Local Company, Local People, Local Expertise

RealLine Diagnostic Kits
Pathogen Detection
Cancer Mutation Detection
Extraction Kits
for Real Time PCR
2013 | 2014
INTRODUCTION
Welcome to BIORON Diagnostics, a company devoted to sharing with you our expertise in the
fast developing areas of Molecular Diagnostics.
BIORON Diagnostics‘ expertise is based on in-depth knowledge of techniques in Molecular
Biology and more than 10 years‘ experience gained by our sister company BIORON GmbH as
a well-known producer of enzymes for molecular biology.
In spite of the fantastic advances in the field of DNA analysis in the last 5 years, real time PCR
remains the most requested technique for practical labs working in DNA/RNA diagnostics.
The majority of BIORON Diagnostics kits for practical applications use real time PCR.
We provide convenient techniques in diagnostics such as lyophilized, ready-to-use mixtures
with a long shelf-life and the ability to be transported at room temperature. All kits are “open
systems” which can be used basically with all current real time PCR machines.
BIORON Diagnostics currently offers the most requested kits for viral / bacterial pathogens detections together with kits unique on the market. BIORON Diagnostics‘ new kits
for Personalized Oncology (Companion Diagnostics) still have limited availability on the
market from other suppliers and we are confident that our solutions will be appreciated by
scientific and medical laboratories.
Continuing our tradition in innovation, new products of BIORON Diagnostics are to be released after setting up the current catalog since quite a lot of products are in the last stages of
development; some are in the R&D pipe-line. Please contact BIORON Diagnostics for updates,
information on the new product in the fascinating area of Molecular Diagnostics. The diagnostic
landscape is changing fast and BIORON Diagnostics team is trying to do everything to help
you in setting up regular and new DNA-diagnostics techniques.
The majority of BIORON Diagnostic Test Kits are CE-marked. We strive to have all our products CE-marked as speedily as possible and, as such, the CE label is clearly marked where
obtained. Our current certification status of all products is clearly indicated in an overview table
in this catalogue. If you have any questions relating to either our CE-marked products or those
for RUO, our sales support team is always glad to help.
Sincerely,
BIORON Diagnostics Team
www.bioron.de
3
TABLE OF CONTENTS
Table of Contents
INTRODUCTION. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
1. PCR KITS FOR PATHOGEN DETECTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Sexually Transmitted Infections (STI). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Candida albicans. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Chlamydia trachomatis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Gardnerella vaginalis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10
Mycoplasma genitalium. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Mycoplasma hominis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Neisseria gonorrhoeae. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
Trichomonas vaginalis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
Ureaplasma urealyticum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Simultaneous detection of two STI. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Candida albicans / Gardnerella vaginalis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16
Chlamydia trachomatis / Mycoplasma genitalium. . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Chlamydia trachomatis / Neisseria gonorrhoeae. . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Chlamydia trachomatis / Trichomonas vaginalis. . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
Chlamydia trachomatis / Ureaplasma urealyticum . . . . . . . . . . . . . . . . . . . . . . . . . . 20
Mycoplasma hominis / Mycoplasma genitalium . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Trichomonas vaginalis / Neisseria gonorrhoeae. . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
Trichomonas vaginalis / Gardnerella vaginalis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
Ureaplasma urealyticum / Ureaplasma parvum. . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
Human Papilloma Virus (HPV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
HPV 16 / 18. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
HPV 31 / 33. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
HPV 35 / 45. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
HPV High Risk, Genotype. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Mycobacterium tuberculosis (TB). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Human Herpesviridae . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Cytomegalovirus (CMV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Eppstein-Barr Virus (EBV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Human Simplex Virus HSV 1/HSV 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30
Human Herpes Virus HHV - 6. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
Human Herpes Virus HHV - 8. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
Varicella-Zoster Virus (VZV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33
Tick Borne Infections. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Anaplasma phagocytophilum / Ehrlichia muris
and Ehrlichia chaffeensis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34
Borrelia burgdorferi s.l. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35
Tick born encephalitis virus (TBEV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36
4
TABLEINTRODUCTION
OF CONTENTS
Rubella . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37
Toxoplasma gondii . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38
Parvovirus B19 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39
Helicobacter pylori . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40
HumanImmunodeficiencyVirus(HIV) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41
Hepatitis C Virus (HCV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Hepatitis B Virus (HBV). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
SUPPLEMENTARY PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Internal Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
Magnetic Rack for Extraction of Nucleic Acids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44
2. KITS FOR CANCER-RELATED MUTATIONS ANALYSIS . . . . . . . . . . . . . . . . . . . . . . . . . . 45
BRAF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46
EGFR . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
KRAS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48
Cancer Mutation DNA Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
3. KITS FOR EXTRACTION OF NUCLEIC ACIDS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
RealLine Transportation Solution . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
Extraction of DNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
RealLine DNA - Express . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50
RealLine DNA - Extraction 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
RealLine DNA - Extraction 3 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51
RealLine FFPE DNA Extraction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
RealLine FFPE DNA Extraction Mag . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
Extraction of DNA and RNA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
RealLine Extraction 100 and 100 (A) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
RealLine Extraction 1000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
4. OVERVIEW TABLES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54
Overview: purpose and use of the RealLine Extraction Kits . . . . . . . . . . . . . . . . . . . . . . 54
Cyclers tested with the RealLine Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55
Available Samples of the RealLine Pathogen Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56
CertificationStatus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58
ALPHABETIC LIST OF PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
IMPRINT / CONDITIONS OF SALES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
www.bioron.de
5
PCR-KITS FOR PATHOGEN DETECTION
INTRODUCTION
PCR-KITS
FOR PATHOGEN DETECTION
RealLine Pathogen Kits
Features:
● Ready to use master mix for detection of DNA or RNA in real time PCR
∞
● Lyophilised Kits with highest stability
∞
● One cycler protocol for the detection of a wide range of pathogens
∞
● Internal Control for reliability and control of extraction and amplification included
∞
● Carry over Protection in DNA detecting kits
∞
● Compatible with the majority of real time PCR detection systems
∞
● Storage at 2 - 8 °C for 12 months
∞
● Transportation: at room temperature for up to 10 days, no cooling required!
∞
● Simultaneous use of different assays, due to the uniform cycler protocol for DNA
∞
detection and nearly the same cycle protocol for RNA detection
Different formats for different cyclers
Str-format: The master mix is lyophilized in strips of 8 x 0.2 ml tubes. Just extract the nucleic
acids (NA) and pipette into the tubes. This format is recommended for block cyclers e.g. BioRad CFX and IQ real-time PCR cycler.
Fla-format: This format can be used for all types of real time PCR cyclers, carousel and
microtiter plate based reactions. 10 reactions (50 µl each) are lyophilized in one vial and
have to be diluted by the recovery solution, dispense the 2-fold concentrated master mix, add
extracted NA and run the test.
Uni-format: The Uni-format can also be used in nearly every cycler, as can be the Strformat.. One tube - one reaction (50 µl). The premix is filled in clear 0.2 ml single PCR tubes
and can be used directly in blockcyclers or dispensed in capillaries, tubes or any kind of
microtiter plates.
6
Explanations
The formats Uni and Str contain the same complete lyophilised master mix. Therefore they
may be used in nearly every cycler. For cycler types without the possibility to use 0.2 ml PCR
tubes directly the master mix of the Uni- and Str-format tubes has to be transferred into the
proprietary plates or capillaries. In this case usage of the Fla-format may offer the advantage
of easier handling by a larger volume for dispensing.
We are pleased to provide you with more information: [email protected]
www.bioron.de
PCR-KITS FOR PATHOGEN DETECTION
PCR-KITS FOR PATHOGEN
INTRODUCTION
DETECTION
7
Candida albicans
Product name
Cat. no
Format
Pack size
RealLine Candida albicans
RealLine Candida albicans
VBD4698
VBD4696
Str
Fla
96 rcs
100 rcs
Candida albicans is a fungus that grows both as yeast and as filamentous cells. Candida albicans infection is an
important cause of morbidity and mortality of immunocompromised patients. Biofilms of Candida albicans may be
formed on the surface of implanted medical devices. Hospital-acquired infections have become a major cause of
health concern.
Applications
The RealLine Candida albicans kits detect Candida albicans DNA in clinical samples by real
time PCR. The kits are designed for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Prevention and control of Candida albicans infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Candida albicans DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla
Fla
Fla, Str
Fla, Str
SEXUALLY TRANSMITTED INFECTIONS (STI)
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS (STI)
Related Products
Product name
RealLine Candida / Gardnerella (Str-format)
RealLine Candida / Gardnerella (Fla-format)
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBD0444
VBD0445
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
96 rcs
100 rcs
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add it
to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
8
Chlamydia trachomatis
SEXUALLY TRANSMITTED INFECTIONS (STI)
0123
Product name
Cat. no
Format
Pack size
RealLine Chlamydia trachomatis
RealLine Chlamydia trachomatis
VBD1998
VBD1996
Str
Fla
96 rcs
100 rcs
0123
Untreated, Chlamydia infections by Chlamydia trachomatis can cause serious reproductive and other health
problems with both short-term and long-term consequences. In both sexes Chlamydia infection can cause
proctitis, trachoma and infertility as well as prostatitis and epididymitis in men, and cervicitis, PID, ectopic
pregnancy and acute/chronic pelvic pain in women.
Chlamydia is known as the “Silent Epidemic” because in women it may not cause any symptoms in 75 % of cases,
and can be latent for months or years before discovered.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
The RealLine Chlamydia trachomatis kits simultaneously detect plasmid and genomic DNA
of Chlamydia trachomatis in clinical samples by real time PCR. The kits are designed for in
vitro diagnostics and provide qualitative detection.
● Prevention and control of Chlamydia trachomatis infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Chlamydia trachomatis
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS
(STI)
INTRODUCTION
Related Products
Product name
Cat. No
Pack size
RealLine Chlamydia / Mycoplasma genitalium (Str-format)
VBD0490
96 rcs
RealLine Chlamydia / Mycoplasma genitalium (Fla-format)
VBD0487
100 rcs
RealLine Chlamydia / Neisseria (Str-format)
VBD0457
96 rcs
RealLine Chlamydia / Neisseria (Fla-format)
VBD0458
100 rcs
RealLine Chlamydia / Trichomonas (Str-format)
VBD0498
96 rcs
RealLine Chlamydia / Trichomonas (Fla-format)
VBD0497
100 rcs
RealLine Chlamydia / Ureaplasma urealyticum (Str-format)
VBD0492
96 rcs
RealLine Chlamydia / Ureaplasma urealyticum (Fla-format)
VBD0491
100 rcs
RealLine DNA – Express
VBC8899
100 rcs
RealLine DNA – Extraction 3
VBC8889
96 rcs
RealLine Extraction 100
VBC8896
48 rcs
RealLine Transport Solution
VBC8894
100 rcs
RealLine Internal Control
VBC8881
250 rcs
RealLine Magnetic Rack
VBE9258 or VBE9291
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection
kits. If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881
and add it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the
protocol.
www.bioron.de
9
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS (STI)
Gardnerella vaginalis
Product name
Cat. no
RealLine Gardnerella vaginalis
RealLine Gardnerella vaginalis
Format
VBD4598
VBD4596
Pack size
Str
Fla
96 rcs
100 rcs
Gardnerella vaginalis is a facultatively anaerobic Gram-variable rod that can cause bacterial vaginosis in some
women as a result of a disruption in the normal vaginal microflora.
Applications
The RealLine Gardnerella vaginalis kits detect the Gardnerella vaginalis DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Gardnerella vaginalis infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Gardnerella vaginalis
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine Candida / Gardnerella (Str-format)
RealLine Candida / Gardnerella (Fla-format)
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBD0444
VBD0445
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
96 rcs
100 rcs
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
10
Mycoplasma genitalium
Product name
RealLine Mycoplasma genitalium
RealLine Mycoplasma genitalium
Cat. no
Format
VBD4396
VBD4394
Str
Fla
Pack size
96 rcs
100 rcs
The Mycoplasma genitalium infection is associated with bacterial vaginosis. In the long term, this infection is
suspected to cause pelvic inflammatory disease (PID).
Applications
The RealLine Mycoplasma genitalium kits detect the Mycoplasma genitalium DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Mycoplasma genitalium infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Saliva
● Urine
● Sperm
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Mycoplasma genitalium
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS
(STI)
INTRODUCTION
Related Products
Product name
RealLine Mycoplasma genitalium / hominis
(Str-format)
RealLine Mycoplasma genitalium / hominis
(Fla-format)
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBD0494
96 rcs
VBD 0493
100 rcs
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
11
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS (STI)
Mycoplasma hominis
Product name
Cat. no
Format
RealLine Mycoplasma hominis
RealLine Mycoplasma hominis
VBD4398
VBD4393
Str
Fla
Pack size
96 rcs
100 rcs
Mycoplasma hominis is a bacterium that infects the mucous membranes of the urethra, cervix, throat and anus.
Various symptoms of infection are known like urethritis (in men), discharge (both sexes), burning while urinating
(both sexes), arthritis/reactive arthritis (mostly men), vaginal itching (women) as well as pain during intercourse
(women).
Applications
The RealLine Mycoplasma hominis kits detect the Mycoplasma hominis DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Mycoplasma hominis infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Saliva
● Urine
● Sperm
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Mycoplasma hominis
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine Mycoplasma genitalium / hominis (Str-format)
RealLine Mycoplasma genitalium / hominis (Fla-format)
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack for Extraction of Nucleic Acids
Cat. no
VBD0494
VBD0493
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBC9291
Pack size
96 rcs
100 rcs
100 rcs
96 rcs
48 rcs
100 rcs
2 × 2 ml
1 unit
We strongly recommend to use the RealLine DNA/RNA extraction along with the corresponding (or relevant) kits.
If other DNA/RNA extraction systems are in use, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples for extraction and real time PCR control according to the protocol.
12
Neisseria gonorrhoeae
Product name
Cat. no
RealLine Neisseria gonorrhoeae
RealLine Neisseria gonorrhoeae
VBD4498
VBD4496
Format
Pack size
Str
Fla
96 rcs
100 rcs
Neisseria gonorrhoeae are gram-negative motile bacteria and the causative agent of Gonorrhoeae, one of the
most common sexually transmitted diseases. In women N. gonorrhoeae can lead to severe symptoms such as
infertility and abortion. In men N. gonorrhoeae can lead to painful urethritis.
Applications
The RealLine Neisseria gonorrhoeae kits detect Neisseria gonorrhoeae DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Neisseria gonorrhoeae infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Neisseria gonorrhoeae
DNA
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS
(STI)
INTRODUCTION
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Related Products
Product name
RealLine Chlamydia / Neisseria (Str-format)
RealLine Chlamydia / Neisseria (Fla-format)
RealLine Trichomonas / Neisseria (Str-format)
RealLine Trichomonas / Neisseria (Fla-format)
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBD0457
VBD0458
VBD0496
VBD0495
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
96 rcs
100 rcs
96 rcs
100 rcs
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
13
PCR-KITS FOR PATHOGEN DETECTION
INTRODUCTION
SEXUALLY
TRANSMITTED INFECTIONS (STI)
Trichomonas vaginalis
Product name
Cat. no
RealLine Trichomonas vaginalis
RealLine Trichomonas vaginalis
VBD2098
VBD2096
Format
Pack size
Str
Fla
96 rcs
100 rcs
Trichomonas vaginalis causes trichomoniasis, a disease that causes vaginal infections in women and urethritis in
men. The transmission of trichomoniasis occurs through sexual intercourse and is one of the most common
sexually transmitted diseases.
Applications
The RealLine Trichomonas vaginalis kits detect Trichomonas vaginalis genomic DNA in
clinical samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Trichomonas infection through early detection and treatment of
asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Trichomonas
vaginalis DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine Chlamydia / Trichomonas
RealLine Chlamydia / Trichomonas
RealLine Trichomonas / Neisseria
RealLine Trichomonas / Neisseria
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
(Str-format)
(Fla-format)
(Str-format)
(Fla-format)
Cat. no
Pack size
VBD0498
VBD0497
VBD0496
VBD0495
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
96 rcs
100 rcs
96 rcs
100 rcs
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
14
Ureaplasma urealyticum
Product name
Cat. no
Format
Pack size
RealLine Ureaplasma urealyticum
RealLine Ureaplasma urealyticum
VBD2298
VBD2296
Str
Fla
96 rcs
100 rcs
Ureaplasma urealyticum is part of the normal genital flora of both men and women. It is found in about 70% of
sexually active humans. It had also been associated with a number of diseases in humans, including non-specific
urethritis, infertility, chorioamnionitis, stillbirth, premature birth and in the perinatal period, pneumonia,
bronchopulmonary dystroplasia as well as meningitis.
Applications
The RealLine Ureaplasma urealyticum kits detect Ureaplasma urealyticum DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Ureaplasma urealyticum infection through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Ureaplasma
urealyticum DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
SEXUALLY TRANSMITTED INFECTIONS
INTRODUCTION
(STI)
Related Products
Product name
RealLine Ureaplasma urealyticum / parvum (Str-format)
RealLine Ureaplasma urealyticum / parvum (Fla-format)
RealLine Chlamydia / Ureaplasma urealyticum (Str-format)
RealLine Chlamydia / Ureaplasma urealyticum (Fla-format)
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBD2294
VBD2295
VBD2292
VBD2291
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
96 rcs
100 rcs
96 rcs
100 rcs
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
15
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION OF TWO STI
Candida albicans / Gardnerella vaginalis
Product name
Cat. no
Format
Pack size
RealLine Candida / Gardnerella
RealLine Candida / Gardnerella
VBD0444
VBD0445
Str
Fla
96 rcs
100 rcs
Candidiasis encompasses infections that range from superficial, such as oral thrush and vaginitis, to systemic and
potentially life-threatening diseases. Candida albicans infections of the latter category are also referred to as
candidemia and are usually confined to severely immunocompromised persons, such as cancer, transplant, and
AIDS patients, as well as non-trauma emergency surgery patients.
Gardnerella vaginalis is a facultatively anaerobic Gram-variable rod that can cause bacterial vaginosis in some
women as a result of a disruption in the normal vaginal microflora.
The RealLine Candida / Gardnerella kits detect and differentiate DNA from Candida
Applications
albicans and Gardnerella vaginalis in clinical samples by real time PCR. The kits are
designed for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Prevention and control of Candida albicans and Gardnerella vaginalis infections through
early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Urine
● Saliva
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Gardnerella vaginalis
DNA
● ROX (575-602 nm)
Candida albicans DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
16
Chlamydia trachomatis / Mycoplasma genitalium
Product name
RealLine Chlamydia / Mycoplasma genitalium
RealLine Chlamydia / Mycoplasma genitalium
Cat. no
Format
VBD0490
VBD0487
Str
Fla
Pack size
96 rcs
100 rcs
Untreated Chlamydia infections by Chlamydia trachomatis can cause serious reproductive and other health
problems with both short-term and long-term consequences.
Mycoplasma genitalium is often asymptomatic, bacterial, sexually transmitted infection which bears some
similarities to T. gonorrhoea and Chlamydia trichomonas. Because mycoplasma genitalium often occurs in
association with other infections in both men and women, doctors still find it quite difficult to diagnose the
condition on its own.
Applications
The RealLine Chlamydia / Mycoplasma genitalium kits detect and differentiate Chlamydia
trachomatis plasmid and genomic DNA and Mycoplasma genitalium DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Chlamydia trachomatis and M. genitalium infections
through early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Saliva
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Chlamydia trachomatis
DNA
● ROX (575-602 nm)
Mycoplasma.
genitalium DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION
OF TWO STI
INTRODUCTION
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
17
PCR-KITS FOR PATHOGEN DETECTION
INTRODUCTION DETECTION OF TWO STI
SIMULTANEOUS
Chlamydia trachomatis / Neisseria gonorrhoeae
Product name
Cat. no
Format
Pack size
RealLine Chlamydia / Neisseria
RealLine Chlamydia / Neisseria
VBD0457
VBD0458
Str
Fla
96 rcs
100 rcs
Untreated, Chlamydia infections by Chlamydia trachomatis can cause serious reproductive and other health
problems with both short-term and long-term consequences. In both sexes Chlamydia infection can cause
proctitis, trachoma and infertility as well as prostatitis, epididymitis in men and cervicitis, PID, ectopic pregnancy
and acute/chronic pelvic pain, in women.
Neisseria gonorrhoeae are gram-negative motile bacteria and the causative agent of gonorrhea (clap), one of the
most common sexually transferred disease. In women gonorrhea can lead to severe symptoms such as infertility
and abortion. In men gonorrhoea can lead to painful urethritis.
Applications
RealLine Chlamydia / Neisseria kits detect and differentiate DNA from Chlamydia
trachomatis and Neisseria gonorrhoeae in clinical samples by real time PCR. The kits are
designed for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Prevention and control of Chlamydia trachomatis and Neisseria gonorrhoeae infections
through early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Chlamydia trachomatis
DNA
Neisseria gonorrhoeae
DNA
● ROX (575-602 nm)
Validated and Tested
Cyclers
Recommended Kit
Formats
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
18
Chlamydia trachomatis / Trichomonas vaginalis
Product name
Cat. no
Format
RealLine Chlamydia / Trichomonas
RealLine Chlamydia / Trichomonas
VBD0498
VBD0497
Str
Fla
Pack size
96 rcs
100 rcs
Untreated Chlamydia infections by Chlamydia trachomatis can cause serious reproductive and other health
problems with both short-term and long-term consequences.
Trichomonas vaginalis causes trichomoniasis, a disease that causes vaginal infections in women and urethritis in
men.
Applications
Indications for Testing
The RealLine Chlamydia / Trichomonas kits detect the Chlamydia trachomatis and
the Trichomonas vaginalis DNA in clinical samples by real time PCR. The kits are
designed for in vitro diagnostics and provide qualitative detection.
● Prevention and control of Chlamydia trachomatis and Trichomonas vaginalis
infections through early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
● Scrapings of epithelial cells
● Saliva
● Urine
Sample Material
Real Time PCR Detection
Channels
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Chlamydia trachomatis
DNA
Trichomonas
vaginalis DNA
● ROX (575-602 nm)
Validated and Tested Cyclers
Recommended Kit Formats
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION
OF TWO STI
INTRODUCTION
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection
kits. If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881
and add it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the
protocol.
www.bioron.de
19
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION OF TWO STI
Chlamydia trachomatis / Ureaplasma urealyticum
Product name
Cat. no
Format
Pack size
RealLine Chlamydia / Ureaplasma urealyticum
RealLine Chlamydia / Ureaplasma urealyticum
VBD0492
VBD0491
Str
Fla
96 rcs
100 rcs
Untreated Chlamydia infections by Chlamydia trachomatis can cause serious reproductive and other health
problems with both short-term and long-term consequences.
Ureaplasma urealyticum is associated with a number of diseases in humans, including non-specific urethritis,
infertility, chorioamnionitis, stillbirth, premature birth and in the perinatal period, pneumonia, bronchopulmonary
dystroplasia as well as meningitis.
Applications
The RealLine Chlamydia / Ureaplasma urealyticum kits detect and differentiate DNA from
Chlamydia trachomatis and Ureaplasma urealyticum in clinical samples by real time PCR.
The kits are designed for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Prevention and control of Chlamydia trachomatis and Ureaplasma urealyticum infections
through early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Chlamydia trachomatis DNA
● ROX (575-602 nm)
Ureaplasma urealyticum DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
20
Mycoplasma hominis / Mycoplasma genitalium
Product name
Cat. no
Format
RealLine Mycoplasma hominis / genitalium
RealLine Mycoplasma hominis / genitalium
VBD0494
VBD0493
Str
Fla
Pack size
96 rcs
100 rcs
Mycoplasma genitalium, Mycoplasma hominis organisms are thought to be associated with non-gonococcal
urethritis (NGU) and other genitourinary infections in clinical samples. Urethritis, an infection often acquired via
sexual contact, is categorized into gonococcal urethritis or nongonococcal urethritis (NGU) depending on the
presence or absence of Neisseria gonorrhoeae. In NGU, the infection is attributed to the pathogenic role of
Chlamydia trachomatis, which has been detected in 30 to 40% of men with NGU, or to other pathogens, including
mycoplasmas and ureaplasmas, in chlamydia-negative patients.
Applications
The RealLine Mycoplasma genitalium / hominis kits detect and differentiate Mycoplasma
hominis and genitalium DNA in clinical samples by real time PCR. The kits are designed
for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Prevention and control of Mycoplasma genitalium and M.hominis infections through early
detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Saliva
● Urine
Real Time PCR Detection
Channels
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Mycoplasma hominis
DNA
Mycoplasma.
Genitalium DNA
● ROX (575-602 nm)
Validated and Tested
Cyclers
Recommended Kit
Formats
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION
OF TWO STI
INTRODUCTION
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
21
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION OF TWO STI
Trichomonas vaginalis / Neisseria gonorrhoeae
Product name
Cat. no
Format
Pack size
RealLine Trichomonas / Neisseria
RealLine Trichomonas / Neisseria
VBD0496
VBD0495
Str
Fla
96 rcs
100 rcs
Trichomonas vaginalis causes trichomoniasis, a disease that causes vaginal infections in women and urethritis in
men. The transmission of trichomoniasis occurs through sexual intercourse and is one of the most common
sexually transmitted diseases.
Neisseria gonorrhoeae are gram-negative motile bacteria and the causative agent of Gonorrhoeae, one of the
most common sexually transmitted diseases. In women N. gonorrhoeae can lead to severe symptoms such as
infertility and abortion. In men N. gonorrhoeae can lead to painful urethritis.
The RealLine Trichomonas / Neisseria kits detect Trichomonas vaginalis and Neisseria
gonorrhoeae DNA in clinical samples by real time PCR. The kits are designed for in vitro
diagnostics and provide qualitative detection.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● Prevention and control of Trichomonas vaginalis and Neisseria gonorrhoeae infections
through early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
● Scrapings of epithelial cells
● Semen
● Urine
● Prostatic fluid
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Trichomonas vaginalis DNA
● ROX (575-602 nm)
Neisseria gonorrhoeae DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
22
Trichomonas vaginalis / Gardnerella vaginalis
Product name
Cat. no
Format
Pack size
RealLine Trichomonas / Gardnerella
RealLine Trichomonas / Gardnerella
VBD0477
VBD0478
Str
Fla
96 rcs
100 rcs
Trichomonas vaginalis causes trichomoniasis, a disease that causes vaginal infections in women and urethritis in
men. The transmission of trichomoniasis occurs through sexual intercourse and is one of the most common
sexually transmitted diseases.
Gardnerella vaginalis is a facultatively anaerobic Gram-variable rod that can cause bacterial vaginosis in some
women as a result of a disruption in the normal vaginal microflora.
Trichomonas vaginalis and Gardnerella vaginalis have similar clinical presentations and can cause a frothy gray
or yellow-green vaginal discharge, pruritus, and produce a positive "whiff-test." With this assay the both
pathogens can be differentiated and especially treated
The RealLine Trichomonas / Gardnerella kits detect Trichomonas vaginalis and
Gardnerella vaginalis DNA in clinical samples by real time PCR. The kits are designed for
in vitro diagnostics and provide qualitative detection.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● Prevention and control of Trichomonas vaginalis and Neisseria gonorrhoeae infections
through early detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
● Scrapings of epithelial cells
● Semen
● Urine
● Prostatic fluid
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Gardnerella vaginalis DNA
● ROX (575-602 nm)
Trichomonas vaginalis DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION
INTRODUCTION
OF TWO STI
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
23
PCR-KITS FOR PATHOGEN DETECTION
SIMULTANEOUS DETECTION OF TWO STI
Ureaplasma urealyticum / Ureaplasma parvum
Product name
Cat. no
Format
Pack size
RealLine Ureaplasma urealyticum/ parvum
RealLine Ureaplasma urealyticum/ parvum
VBD2294
VBD2295
Str
Fla
96 rcs
100 rcs
Ureaplasma parvum is generally the most common species detected in various clinical specimens. Ureaplasma
urealyticum is apparently more pathogenic in conditions such as male urethritis. Ureaplasma urealyticum is part
of the normal genital flora of both men and women. In about 70% of sexually active humans it is found and is
described to be associated with a number of diseases in humans, including non-specific urethritis (NSU),
infertility, chorioamnionitis, stillbirth, premature birth and others.
Applications
The RealLine Ureaplasma urealyticum / parvum kits detect the Ureaplasma urealyticum
and Ureaplasma parvum DNA in clinical samples by real time PCR and in different
channels. The kits are designed for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Prevention and contro of Ureaplasma urealyticum / U. parvum infections through early
detection and treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Urine
● Prostatic fluid
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Ureaplasma urealyticum DNA
● ROX (575-602 nm)
Ureaplasma parvum DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
24
Human Papilloma Virus (HPV) - High Carcinogenic Risk Types
Product name
RealLine HPV 16 / 18
RealLine HPV 16 / 18
RealLine HPV 31 / 33
RealLine HPV 31 / 33
RealLine HPV 35 / 45
RealLine HPV 35 / 45
Cat. no
Format
Pack size
VBD8473
VBD8474
VBD8471
VBD8480
VBD8469
VBD8477
Str
Fla
Str
Fla
Str
Fla
96 rcs
100 rcs
96 rcs
100 rcs
96 rcs
100 rcs
Human Papilloma Viruses HPV are DNA-Viruses of which more than 100 different types are known. While the
majority of HPVs cause no symptoms, some can cause low severe symptoms like warts and a few are know to
cause cancer, especially cervical cancer in women. The HPV types that are more likely to lead to the
development of cancer are referred to as “high cancer-risk” types HPV.
Applications
The RealLine HPV Kits are designed for sensitive direct detection of HPV high cancer risk
genotypes in clinical samples by real time PCR. The kits are designed for in vitro
diagnostics, for qualitative or quantitative detection. The detection of the types of Papilloma
viruses are dependent on the different kits. In double kits the named HPV types and the
internal control are detected.
Indications for Testing
● Assess risk of cervical cancer in women of 30 years and above as an adjunct to cytology
results
● Risk analysis of cervical cancer in women who have an ASC-US cervical cytology results
● Estimation of the impact of HPV vaccination on risk of acquisition and on distribution of
individual HPV types in a population
Sample Material
● Blood serum, plasma
● Scrapings of epithelial cells
● Urine
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
HPV genotypes
● ROX (575-602 nm)
HPV genotypes
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
HUMAN PAPILLOMA
VIRUS (HPV)
INTRODUCTION
Related Products
Product name
Cat. no
Pack size
RealLine DNA – Express
VBC8899
100 rcs
RealLine DNA – Extraction 3
VBC8889
96 rcs
RealLine Extraction 100
VBC8896
48 rcs
RealLine Transport Solution
VBC8894
100 rcs
RealLine Internal Control
VBC8881
250 rcs
RealLine Magnetic Rack
VBE9258 or VBE9291
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
25
PCR-KITS FOR PATHOGEN DETECTION
HUMAN PAPILLOMA VIRUS (HPV)
Human Papilloma Virus (HPV) – High Cancer Risk Types – Genotyping
Product name
Cat. no
Format
Pack size
RealLine HPV High Risk, Genotype
RealLine HPV High Risk, Genotype, quantitative
RealLine HPV High Risk, Genotype
VBD8479
VBD8478
VBD8482
Str
Str
Fla
96 rcs
96 rcs
100 rcs
High carcinogenic risk types of Human Papilloma Viruses HPV can lead to invasive cervical cancer in women.
One or more of this types are detected in the tumor cells.
Applications
The genotyping RealLine HPV Kits are designed for sensitive direct detection of HPV high
carcinogenic risk genotypes in clinical samples by real time PCR. The IVD kits are
designed for qualitative or quantitative detection. In the genotyping kits following HPV types
can be detected: 6, 11, 16, 18, 31, 33, 35, 45, 51, 52, 56, 58.
Indications for Testing
● Assess risk of cervical cancer in women of 30 years and above as an adjunct to cytology
results
● Risk analysis of cervical cancer in women who have an ASC-US cervical cytology results
● Estimation of the impact of HPV vaccination on risk of acquisition and on distribution of
individual HPV types in a population
Sample Material
Real Time PCR Detection
Channels
● Blood serum, plasma
● Scrapings of epithelial cells
● Urine
● Cy5 (647-667 nm)
Internal Control IC
● FAM (495-520 nm)
HPV genotypes DNA
● HEX (535-554 nm)
HPV genotypes DNA
● ROX (575-602 nm)
HPV genotypes DNA
HMBS Gene in
quantitative assay
Validated and Tested
Cyclers
Recommended Kit
Formats
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Related Products
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Product name
Cat. no
Pack size
RealLine DNA – Express
VBC8899
100 rcs
RealLine DNA – Extraction 3
VBC8889
96 rcs
RealLine Extraction 100
VBC8896
48 rcs
RealLine Transport Solution
VBC8894
100 rcs
RealLine Internal Control
VBC8881
250 rcs
RealLine Magnetic Rack
VBE9258 or VBE9291
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
26
Mycobacterium tuberculosis
Product name
RealLine Mycobacterium tuberculosis
incl. Extraction
RealLine Mycobacterium tuberculosis
Cat. no
Format
Pack size
VBD2398
Uni
48 rcs
VBD2399
Str
96 rcs
Tuberculosis, also named MBT, TBC or TB, is a world-wide, common and often lethal infectious disease caused
by Mycobacterium tuberculosis. The number of new infections is still increasing. Tuberculosis usually attacks the
lungs, but also other parts of the body can be affected. The infection is spread by droplet infection and causes
symptoms like chronic coughing with blood-tinged sputum, fever, nocturnal sweats and weight loss.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
The RealLine Mycobacterium tuberculosis kit is designed to detect DNA of Mycobacterium
tuberculosis complex isolated from clinical specimens using real time PCR method with
fluorescent detection of an amplified product.
● Detection of Tuberculosis from clinical specimen
● Blood serum, plasma
● Whole blood
● Biopsy material, liquor
● Urine
● Epithelial cells specimens, cultures of microorganisms, swabs of environmental objects
● Bronchopulmonary lavage
● Sputum
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Tuberculosis-complex
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Uni, Str
Uni, Str
Uni, Str
Uni, Str
Uni, Str
Uni, Str
Uni, Str
PCR-KITS FOR PATHOGEN DETECTION
MYCOBACTERIUM TUBERCULOSIS
(TB)
INTRODUCTION
Related Products
Product name
RealLine Transport Solution
RealLine Extraction 100
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8894
VBC8896
VBC8881
VBE9258 or VBE9291
Pack size
100 rcs
48 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
27
PCR-KITS FOR PATHOGEN DETECTION
HUMAN HERPESVIRIDAE
Cytomegalovirus CMV
0123 0123
0123
Product name
Cat. no
Format
RealLine CMV
RealLine CMV
VBD1598
VBD1596
Str
Fla
Pack size
96 rcs
100 rcs
CMV infection is important for certain high-risk groups: patients who are immunocompromised e.g. patients with
HIV, organ transplant recipients, persons with leukemia, foeti and neonatal infants. CMV is one of the TORCH
infections which leads to congenital abnormalities and therefore an early diagnosis of CMV especially for
pregnant women and women of reproductive age is extremely important.
Applications
The RealLine CMV kits are designed for the sensitive direct detection of CMV DNA in
clinical samples by real time PCR. The kits are designed for in vitro Diagnostics and for
qualitative detection.
Indications for Testing
● Identification of active and latent infections.
● Estimation of acute infection appearance risk.
Sample Material
● Scrapings of epithelial cells
● Saliva
● Semen
● Prostatic fluid
● Urine
● Whole blood, serum or plasma
● Leukocytic mass
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
CMV DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8899
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
100 rcs
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
28
Eppstein-Barr-Virus EBV
Product name
Cat. no
Format
RealLine EBV
RealLine EBV
VBD2198
VBD2196
Str
Fla
Pack size
96 rcs
100 rcs
EBV is quite common in population leaving the majority of individuals with a lifelong silent infection. Many children
become infected with EBV asymptomatically. The virus is the causative agent of infectious mononucleosis. EBV is
associated with the development of two epithelial tumors, nasopharyngeal carcinoma and oral hairy leukoplakia.
Applications
The RealLine EBV kits are designed for sensitive direct detection of EBV DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and provide for
qualitative detection.
Indications for Testing
● Identification of active and latent infections
● Epidemiological studies
Sample Material
● Whole blood
● Blood serum, plasma
● Saliva
● Swabs from the nasal mucosa
● Scrapings of the epithelial cells
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
EBV DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
HUMAN HERPESVIRIDAE
INTRODUCTION
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
29
PCR-KITS FOR PATHOGEN DETECTION
HUMAN HERPESVIRIDAE
Herpes Simplex Virus HSV-1/ HSV-2
Product name
Cat. no
Format
Pack size
RealLine HSV-1/ HSV-2
RealLine HSV-1/ HSV-2
VBD2195
VBD2197
Str
Fla
96 rcs
100 rcs
HSV-1 is an oral form of herpes typically affecting the mouth and surrounding areas on the face. In addition, HSV1 can cause encephalitis, keratoconjunctivitis, stomatitis and skin infections. Transmission generally occurs
through saliva and rarely through sex contact. HSV-2 causes most cases of genital herpes as well as the
neurological manifestations such as meningitis and radiculitis. Pregnant women and infants are risk groups for
HSV infections since when infants do contract neonatal herpes, they may suffer serious neurological damage,
mental retardation or death. In addition HSV-2 is known to increase a person’s risk of contracting HIV.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
The RealLine HSV-1 / HSV-2 kit is designed for in vitro diagnostics and the detection and
differentiation of HSV-1 and HSV-2 DNA in clinical samples by real time PCR. The kits are
designed for in vitro diagnostics and provides qualitative detection.
● The RealLine HSV-1 / HSV-2 kits are used for direct detection and genotyping of HSV-1
and HSV- 2 infection in clinical specimens.
● Scrapings of epithelial cells
● Saliva
● Semen
● Prostatic fluid
● Urine
● Whole blood, serum or plasma
● Leukocytic mass
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
HSV-1 DNA
● ROX (575-602 nm)
HSV-2 DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
30
Human Herpes Virus HHV-6
Product name
Cat. no
Format
RealLine HHV-6
RealLine HHV-6
VBD2150
VBD2151
Str
Fla
Pack size
48 rcs
50 rcs
HHV-6 infections can occur early in life asymptomatically with lifelong persistence. Primary infection with HHV-6
causes roseola infantum, a common childhood disease that resolves spontaneously. The virus remains latent in
lymphocytes and monocytes and persists at low levels in cells and tissues. It can reactivate at a later date, and is
believed to contribute to diseases of the bone marrow and/or central nervous system in some patients, including
mononucleosis, illness with fever, lymphadenopathy, hepatitis, fatal encephalitis, chronic fatigue syndrome, and
possibly multiple sclerosis. Transmission of HHV-6 is believed to occur as a result of exposure to saliva.
Applications
The RealLine HHV-6 kits are designed for sensitive direct detection of HHV-6 DNA in
clinical samples by real time PCR. The kits are designed for in vitro diagnostics and a
qualitative detection of HHV-6.
Indications for Testing
● Detection of acute reactivation of HHV-8 infection in clinical samples of
immunocompromised individuals
● Detection of acute reactivation of HHV-6 infection in transplant patients
● HHV-6 detection in the serum during primary roseola infection in pediatric populations
Sample Material
● Scrapings of epithelial cells
● Saliva
● Semen
● Prostatic fluid
● Urine
● Whole blood, serum or plasma
● Leukocytic mass
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
HHV-6 DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
HUMAN HERPESVIRIDAE
INTRODUCTION
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
31
PCR-KITS FOR PATHOGEN DETECTION
HUMAN HERPESVIRIDAE
Human Herpes Virus HHV-8
Product name
Cat. no
Format
Pack size
RealLine HHV-8
RealLine HHV-8
VBD2148
VBD2149
Str
Fla
48 rcs
50 rcs
HHV-8 is a cancer-causing herpes virus. Most people infected with HHV-8 do not know about the infection. After
infection, the virus enters the lymphocytes where it remains latent. HHV-8 mostly causes disease in
immunocompromised individuals. HHV-8 can lead to Kaposi‘s sarcoma, lymphoma, multicentric Castleman‘s
disease, a non Hodgkin‘s Disease and hypergammaglobulinemia.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
The RealLine HHV-8 kits are designed for sensitive direct detection of HHV-8 DNA in clinical
samples by real time PCR. The kits are designed for In vitro diagnostics and qualitative
detection of Human-Herpes-Virus 8.
● Detection of acute reactivation of HHV-8 infection in clinical samples of
immunocompromised individuals
● Scrapings of epithelial cells
● Saliva
● Semen
● Prostatic fluid
● Urine
● Whole blood, serum or plasma
● Leukocytic mass
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
HHV-8 DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
32
Varicella Zoster Virus VZV
Product name
Cat. no
Format
Pack size
RealLine VZV
RealLine VZV
VBD2185
VBD2187
Str
Fla
48 rcs
50 rcs
Primary VZV infection causes chicken-pox in children and serious complications of shingles include postherpetic
neuralgia, zoster multiplex, myelitis, herpes ophthalmicus, or zoster sine herpete in adults, however rarely in
children. In about 10 – 20 % of the cases, VZV reactivates later in life. It most commonly occurs in people over
age 50, and in those with a weakened immune system.
Applications
The RealLine VZV kit is designed for sensitive direct detection of VZV DNA in clinical
samples by real time PCR. The kits are designed for In vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Identification of active and latent infections.
● Detection of primary VZV infection or acute reactivation in pregnant woman or those
considering pregnancy.
● Detection of primary VZV infection in health workers prior to varicella vaccination or after
exposure to VZV.
Sample Material
● Scrapings of epithelial cells
● Saliva
● Semen
● Prostatic fluid
● Urine
● Whole blood, serum or plasma
● Leukocytic mass
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
VZV DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
HUMAN HERPESVIRIDAE
INTRODUCTION
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
2 × 2 ml
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
33
PCR-KITS FOR PATHOGEN DETECTION
TICK BORNE INFECTIONS
Anaplasma phagocytophilium, Ehrlichia muris and E. chaffeensis
Product name
RealLine Anaplasma / Ehrlichia
RealLine Anaplasma / Ehrlichia
Cat. no
Format
Pack size
VBD5398
VBD5399
Str
Fla
48 rcs
50 rcs
Ehrlichiosis or human granulocytic anaplasmosis are diseases which can be caused by Anaplasma
phagocytophilum, Ehrlichia chaffeensis or Ehrlichia muris. Humans and other mammals are infected by bites of
ticks. If the disease is symptomatic it can come to flue-like symptoms up to serious symptoms like
Meningoencepahiltis especially in immunosupressed patients.
Applications
The RealLine Anaplasma / Ehrlichia kits detect and differentiate DNA of Anaplasma
phagocytophilium and of Ehrlichia muris and E.chaffeensis in clinical samples by real time
PCR. The kits are designed for in vitro diagnostics and provide qualitative detection.
Indications for Testing
● Persons with a risk and clinical symptoms of a Ehrlichiosis or Anaplasmosis
Sample Material
● Blood serum, plasma
● Cerebrospinal fluid
● Tick suspension samples
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
Anaplasma
phagocytophilium DNA
● ROX (575-602 nm)
Ehrlichia muris and
chaffeensis DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
34
Borrelia burgdorferi s.l.
Product name
RealLine Borrelia burgdorferi s.l.
RealLine Borrelia burgdorferi s.l.
Cat. no
Format
Pack size
VBD1498
VBD1499
Str
Fla
48 rcs
50 rcs
Lyme disease or borreliosis is considered to be one of the fastest spreading illnesses in the world. Gram negative
spirochetal bacteria from the genus Borrelia, collectively known as the Borrelia burgdorferi sensu lato group,
cause Lyme disease.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
The RealLine Borrelia burgdorferi sensu lato kits detect the B. burgdorferi sensu lato group
(Borrelia afzelii, Borrelia garinii, Borrelia burgdorferi sensu stricto) DNA in clinical samples
by real time PCR. The kits are designed for in vitro diagnostics and provide qualitative
detection.
● Persons with a risk for Lyme disease and
● Patients with clinical symptoms for Borreliosis
● Blood serum, plasma
● Cerebrospinal fluid
● Tick suspension samples
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Borrelia burgdorferi s.l
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
TICK BORNE
INFECTIONS
INTRODUCTION
Related Products
Product name
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8897
VBC8889
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
96 rcs
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
35
PCR-KITS FOR PATHOGEN DETECTION
TICK BORNE INFECTIONS
Tick Borne Encephalitis Virus TBEV
Product name
Cat. no
Format
Pack size
RealLine TBEV
RealLine TBEV
VBD1198
VBD1199
Str
Fla
48 rcs
50 rcs
TBEV is endemic in an area ranging from northern China and Japan through far-eastern Russia to Europe. TBEV
is transmitted by the bite of infected ticks, or (rarely) through the non-pasteurized milk of infected cows, sheep
and goats. TBEV is a viral infectious disease involving the central nervous system (CNS). The disease is
incurable once manifested, so there is no specific drug therapy for TBEV.
Applications
The RealLine TBEV kit is designed for sensitive direct detection of TBEV RNA in clinical
samples by one-step real time RT-PCR. The kits are designed for in vitro diagnostics and
provides qualitative detection.
Indications for Testing
● Patients with typical CNS symptoms
● Tick bite
Sample Material
● Blood serum, plasma
● Cerebrospinal fluid
● Tick suspension samples
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
TBEV RNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
36
Rubella
0123 0123
0123
Product name
Cat. no
Format
Pack size
RealLine Rubella
RealLine Rubella
VBD2598
VBD2596
Str
Fla
48 rcs
50 rcs
Rubella is a common childhood infection usually with minimal systemic upset although transient arthropathy may
occur in adults. The primary medical danger of Rubella is the infection of pregnant women because it can cause
congenital rubella syndrome (CRS) in the developing fetus which entails a range of incurable serious illnesses.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
The RealLine Rubella kits are designed for sensitive direct detection of Rubella RNA in
clinical samples by one-step real time PCR. The kits are designed for qualitative in vitro
diagnostics.
● Detection of Rubella infection in pregnant woman or those considering pregnancy.
● Analysis prior to vaccination.
● Follow up after exposure to Rubella infection.
● blood serum
● plasma
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Rubella RNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
RUBELLA
INTRODUCTION
Related Products
Product name
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
37
PCR-KITS FOR PATHOGEN DETECTION
TOXOPLASMA GONDII
Toxoplasma gondii
0123
Product name
Cat. no
Format
Pack size
RealLine Toxoplasma
gondii
VBD1798
Str
48 rcs
RealLine Toxoplasma
gondii
VBD1796
Fla
100 rcs
Toxoplasma gondii is a species of parasitic protozoa of the genus Toxoplasma. Early and definitive diagnosis is
very important for recently infected pregnant women in order to prevent infection of the fetus by appropriate
treatment as well as for persons with severely weakened immune systems.
Applications
The RealLine Toxoplasma gondii detection by real time PCR is based on the amplification of
DNA corresponding to a specific region of the pathogen genome.
Indications for Testing
● Detection of acute reactivation of T. gondii infection in clinical samples of
immunocompromised individuals.
● Test of pregnant women with a risk of T. gondii infection.
Sample Material
● blood serum
● plasma
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
Recommended Kit
Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Toxoplasma gondii DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Extraction 2
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8897
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
96 rcs
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We str
ecommend usi
he RealLine DNA/RNA extraction al
ith the RealLine pat
ection
kits. If other DNA/RNA extracti
ems are used, please order the RealLine Internal Control IC #VBC8881
and add it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the
protocol.
38
Parvovirus B19
Product name
Cat. no
Format
Pack size
RealLine Parvovirus B19
RealLine Parvovirus B19
VBD2801
VBD2802
Str
Fla
96 rcs
100 rcs
Parvovirus B19 or just B19, is a small single-stranded DNA virus of the parvovirus family. It can cause several
diseases such as “the fifth disease (erythema infectiosum)” in children. Especially in girls and young women the
disease can develop and affect the joints, known as acute symmetric polyarthropathy. Parvovirus B19 replicates
only in erythroblasts, the progenitors of red blood cells (erythrocytes) in the bone marrow. Therefore, the infection
triggers in each patient a temporary anemia which can cause complications and even death in
immunocompromised individuals. During pregnancy B19 can lead to spontaneous abortions and other
complications such as fetal hydrops, which can seriously harm the fetus if not recognized.
Applications
The RealLine Parvovirus B19 kits detect Parvovirus B19 DNA in clinical samples
by real time PCR. The kits are designed for in vitro diagnostics and provide
qualitative detection.
Indications for Testing
● Prevention and control of Parvovirus B19 infections through early detection and
treatment of asymptomatic infection.
● Reduction of onward transmission to sexual partners.
● Prevention of the consequences of untreated infection.
Sample Material
● Scrapings of epithelial cells
● Semen
● Prostatic fluid
● Urine
Real Time PCR Detection
Channels
Validated and Tested Cyclers
Recommended Kit Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Parvovirus B19 DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
PCR-KITS FOR PATHOGEN DETECTION
PARVOVIRUS
B19
INTRODUCTION
Related Products
Product name
RealLine DNA – Express
RealLine DNA – Extraction 2
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8899
VBC8897
VBC8889
VBC8896
VBC8894
VBC8881
VBE9258 or VBE9291
100 rcs
96 rcs
96 rcs
48 rcs
100 rcs
250 rcs
1 unit
We str
ecommend usi
he RealLine DNA/RNA extraction al
ith the RealLine pat
ection kits.
If other DNA/RNA extractio
stems are used, please order the RealLine Internal Control IC #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
39
PCR-KITS FOR PATHOGEN DETECTION
HELICOBACTER PYLORI
Helicobacter pylori
Product name
Cat. no
Format
Pack size
RealLine Helicobacter pylori
RealLine Helicobacter pylori
VBD3798
VBD3796
Str
Fla
48 rcs
50 rcs
Helicobacter pylori is a gram-negative, microaerophilic bacterium found in the stomach. The most people infected
with H.pylori show no symptoms, but an acute infection may appear as an acute gastritis with abdominal pain
(stomach ache) or nausea. Where an acute gastritis cause a chronic gastritis, the symptoms, are often those of
non-ulcer dyspepsia: stomach pains, nausea, bloating, belching, and sometimes vomiting or black stool. The
presence of H.pylori is a risk factor for gastric cancer.
Applications
The RealLine Helicobacter pylori kits detect Helicobacter pylori DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and
provide qualitative detection.
Indications for Testing
● Initial diagnostics of H. pylori
● Confirmation of the cure
Sample Material
● Stomach tissue samples
Real Time PCR Detection
Channels
Validated and Tested Cyclers
Recommended Kit Formats
● FAM (495-520 nm)
Internal Control IC
● ROX (575-602 nm)
Helicobacter pylori
DNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Fla
Fla
Fla
Str, Fla,
Fla
Fla, Str
Fla, Str
Related Products
Product name
RealLine DNA – Extraction 2
RealLine Extraction 100
RealLine Transport Solution
RealLine Magnetic Rack
Cat. no
VBC8897
VBC8896
VBC8894
VBE9258 or VBE9291
Pack size
96 rcs
48 rcs
100 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please use the special “RealLine Helicobacter Internal Control”
which is provided with the kit and add it to the samples as well as the controls prior to DNA/RNA extraction
procedure as indicated in the protocol.
40
Human Immunodeficiency Virus (HIV)
Product name
RealLine HIV qualitative
RealLine HIV quantitative
RealLine HIV qualitative incl. Extraction
RealLine HIV quantitative incl. Extraction
Cat. no
Format
VBD0196
VBD0195
VBD0198
VBD0199
Str
Str
Uni
Uni
Pack size
96 rcs
96 tcs
48 rcs
48 rcs
Human immunodeficiency virus (HIV) is a member of the genus Lentivirus, part of the family of Retroviridae, that
causes acquired immunodeficiency syndrome (AIDS). Since its discovery in 1981 AIDS has killed more than 25
million people.
Applications
The RealLine HIV kits are designed to direct detection and quantification of HIV
RNA in clinical samples by real time RT-PCR. The kits are designed for in vitro
diagnostics and provides qualitative or quantitative detection.
Indications for Testing
RealLine qualitative detection
● Screening of plasma specimens from blood donors.
● Research on primary HIV infection.
● Identification of individuals with high viral replication (to identify highly
contagious individuals).
● Monitoring of mother-to-child transmission.
Sample Material
RealLine quantitative detection
● Assessing disease progression.
● Monitoring of the effect of anti-retroviral treatment.
● Determination of the level of viral load in the blood.
● Blood serum, plasma
● FAM (495-520 nm)
Internal Control IC
(in quantitative kits:
Standard CS1)
● ROX (575-602 nm)
HIV RNA
(in quantitative kits:
Standard CS2)
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Uni
Uni, Str
Uni, Str
Str, Uni
Uni
Uni, Str
Uni, Str
Real Time PCR Detection
Channels
Validated and Tested Cyclers
Recommended Kit Formats
PCR-KITS FOR PATHOGEN DETECTION
HUMAN IMMUNODEFICIENCY
VIRUS (HIV)
INTRODUCTION
Related Products
Product name
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
41
PCR-KITS FOR PATHOGEN DETECTION
HEPATITIS C VIRUS (HCV)
Hepatitis C Virus (HCV)
Product name
RealLine HCV Genotype qualitative
RealLine HCV Genotype quantitative
RealLine HCV qualitative
RealLine HCV quantitative
RealLine HCV qualitative incl. extraction
RealLine HCV quantitative incl. extraction
Cat. no
Format
Pack size
VBD0793
VBD0797
VBD0795
VBD0794
VBD0798
VBD0799
Uni
Str
Str
Str
Uni
Uni
48 rcs
48 rcs
96 rcs
96 rcs
48 rcs
48 rcs
Hepatitis C virus (HCV) is a public health concern worldwide and a major cause of chronic liver inflammation,
cirrhosis and hepatocellular carcinoma. It is transmitted parenterally, showing a high incidence in hemophiliacs,
hemodialysis patients, drug users using contaminated syringes, and patients with post-transfusion hepatitis.
Applications
Indications for Testing
Qualitative and quantitative RealLine HCV kits are designed for laboratory
diagnostics or high-throughput analysis of HCV RNA by real time PCR.
The RealLine HCV Genotype (quantitative) Kit is a reagent kit for the detection,
quantitative determination and differentiation of HCV genotypes 1, 2 and 3 RNA.
● Protection of the blood supply
● Diagnostics of infection with HCV (HCV RNA is detectable by RT-PCR 1-2 weeks
after exposure).
● Determination whether an individual is a chronic carrier.
● Evaluation of the effect of anti-HCV therapies (interferon (IFN) monotherapy or in
combination with ribavirin).
● Determination of the viral load in an individual who is considering therapy.
● Observation of the rate of decline of viral load during the first few weeks of
treatment as a predictor of complete response.
● Blood serum, plasma
Sample Material
Real Time PCR Detection
Channels
Validated and Tested Cyclers
Recommended Kit Formats
● FAM (495-520 nm)
Internal Control IC
● HEX (535-554 nm)
HCV genotypes RNA
● ROX (575-602 nm)
HCV genotypes RNA
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Uni
Uni, Str
Uni, Str
Str, Uni
Uni
Uni, Str
Uni, Str
Related Products
Product name
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
Pack size
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
42
Hepatitis B Virus (HBV)
Product name
RealLine HBV qualitative
RealLine HBV quantitative
RealLine HBV qualitative incl. extraction
RealLine HBV quantitative incl. extraction
Cat. no
Format
VBD0596
VBD0595
VBD0598
VBD0599
Str
Str
Uni
Uni
Pack size
96 rcs
96 rcs
48 rcs
48 rcs
HBV is a partially double-stranded DNA virus of the Hepadnaviridae family that causes acute and chronic liver
disease with a very high risk of death from liver cirrhosis and cancer. Worldwide an estimated 2 billion people
have been infected with the hepatitis B virus(HBV) and more than 350 million suffer chronic consequences from
the disease.
Applications
The RealLine HBV kits detect the different genotypes of HBV DNA in clinical
samples by real time PCR. The kits are designed for in vitro diagnostics and
provide qualitative or quantitative detection.
Indications for Testing
● Screening of plasma specimens from blood donors.
● Perform screens of plasma specimens from blood donors.
● Identification of individuals with high viral replication.
● Determination if someone is a HBV chronic carrier.
● To detect previous infection (with subsequent immunity).
● Analysis of small subgroups of patients who are HBeAg negative but carry the
HBV virion.
● Assess disease progression.
● Monitoring the efficacy of antiviral therapy.
● Detect the occurrence of drug-resistant mutants.
Sample Material
● Blood serum, plasma
● FAM (495-520 nm)
Internal Control IC (in
quantitative kits:
Standard CS1)
● ROX (575-602 nm)
HBV DNA (in
quantitative kits:
Standard CS2)
● Bio-Rad CFX96™, iQ™ (Bio-Rad, USA)
®
● Rotor-Gene 3000/6000 (QIAGEN, Germany)
● Eco Cycler (Illumina, USA)
● DTPrime, DTLite (DNA-Technology, Russia)
®
● LightCycler 480 and 2.0 (Roche, Switzerland)
● AB 7300/7500 (Applied Biosystems, USA)
● Mastercycler (Eppendorf, Germany
Str, Uni
Uni, Str
Uni, Str
Str, Uni
Uni
Uni, Str
Uni, Str
Real Time PCR Detection
Channels
Validated and Tested Cyclers
Recommended Kit Formats
PCR-KITS FOR PATHOGEN DETECTION
HEPATITISINTRODUCTION
B VIRUS (HBV)
Related Products
Product name
RealLine Extraction 100
RealLine Extraction 1000
RealLine Transport Solution
RealLine Internal Control
RealLine Magnetic Rack
Cat. no
VBC8896
VBC8895
VBC8894
VBC8881
VBE9258 or VBE9291
Pack size
48 rcs
48 rcs
100 rcs
250 rcs
1 unit
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, please order the RealLine Internal Control (IC) #VBC8881 and add
it to the samples as well as the controls prior to DNA/RNA extraction procedure as indicated in the protocol.
www.bioron.de
43
PCR-KITS FOR PATHOGEN DETECTION
SUPPLEMENTARY PRODUCTS
Internal Control for RealLine Pathogen Kits
Product name
Cat. no
Pack size
RealLine Internal Control
VBC8881
250 rcs
An Internal Control, IC, should be included in each sample in order to verify that all procedures starting from the
extraction of DNA or RNA to the detection and analysis are functioning correctly.
Normally Internal Control is supplied together with RealLine DNA/RNA extraction kits.
We strongly recommend using the RealLine DNA/RNA extraction along with the RealLine pathogen detection kits.
If other DNA/RNA extraction systems are used, the IC should be added to the samples and to the controls prior to
DNA/RNA extraction procedure as indicated in the protocol.
Target DNA/RNA should be isolated jointly with Internal control IC for the extraction and real
time PCR efficiency control in each sample.
Applications
RealLine Magnetic Rack
Product name
RealLine Magnetic Rack, exchangeable plastic covers
Realline Magnetic Rack, fix plastic cover
Cat. no
Pack size
VBE9291
VBE9258
1 unit
1 unit
There are two magnetic racks available for the simple and fast magnetic spheres based DNA/RNA extraction
procedures:
- with exchangeable plastic covers for prevention of contamination
- fix autoclavable plastic
One magnetic rack enables to perform 12 to 16 simultaneous DNA/RNA extractions with magnetic spheres based
extraction systems.
Related Products
Product name
RealLine DNA – Extraction 3
RealLine Extraction 100
RealLine Extraction 1000
44
Cat. no
Pack size
VBC8889
VBC8896
VBC8895
96 rcs
48 rcs
48 rcs
Kits for Cancer Mutation Analysis
The RealLine Oncoline kits are a new generation of cancer mutations detection kits based on AlleleSpecific real time PCR detection and fast analysis.
BRAF
BRAF, a serine-threonine kinase, is one members of the RAF protein kinase family. Activating
mutations in BRAF were described in cases of melanoma, papillary thyroid cancer, testicular, ovarian
and colon cancers. Most common (~80%) of these somatic mutations is a missense mutation T1799A
within the kinase domain of the BRAF that leads to change of Valine (Val) to Glutamic acid (Glu) at
position 600 (V600E). The selective inhibitor of BRAF – Zelboraf (Vemurafenib/PLX4032) (Roche) was
designed for the target therapy of melanoma which harbours BRAF-V600E mutation.
CANCER MUTATION DETECTION
CANCER MUTATION DETECTION
KRAS
Colorectal cancer (mCRC) is the fourth most common cancer among men and women. About 40% of
mCRC patients have mutations of the KRAS gene in the tumor. Tumors with KRAS mutations in
codons 12 or 13 are resistant to anti-EGFR therapy. Accordingly, anti-EGFR therapy of mCRC using
Erbitux® or Vectibix® is recommended only for tumors without such mutations.
EGFR
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer. About 10% of NSCLC
cases have activating mutations in the epidermal growth factor receptor (EGFR) gene. Most of these
somatic mutations (~90%) are within the tyrosine kinase (TK) domain of EGFR and occur as either an
in-frame deletion of 3-6 amino acids that corresponds to codons 746-750 (del 746-750), or a missense
mutation T2573G that leads to change of Leu to Arg at position 858 (L858R). The European Society
for Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) recommend EGFR
mutation testing for selection of NSCLC patients who could benefit from anti-EGFR therapy.
www.bioron.de
45
CANCER MUTATION DETECTION
CANCER MUTATION DETECTION
BRAF
Product name
RealLine BRAF Detect V600E, Kit for Real Time PCR
RealLine BRAF Detect V600E, Kit for Real Time PCR
Applications
Indications for Testing
Sample Material
Cat. no
Pack size
MED20701
MED20710
12 rcs
36 rcs
The kits are designed to detect missense mutation GTG→GAG at codon 600 of the BRAF
gene which is associated with the sensitivity to the therapy with BRAF inhibitors. Also
mutations of GTG to GAA, GAT, and AAG are detected by allele specific real time PCR.
● melanoma tumours and other BRAF associated tumors
● screening of the mutation for the decision of the therapy selection for the patient
● DNA extracted from fresh, fresh-frozen or formalin-fixed paraffin-embedded, (FFPE)
tumor tissue section can be tested.
● FAM (495-520 nm)
Real Time PCR Detection
Channels
BRAF-V600E
● ROX (575-602 nm)
Internal Control IC
Validated and Tested
Cyclers
● Bio-Rad iQ™, iQ™5, CFX96™ (Bio-Rad, USA)
● LightCycler® Nano System (Roche, Switzerland)
● DTPrime, DTLite (DNA-Technology, Russia)
Related Products
Product name
46
Cat. no
Pack size
RealLine FFPE DNA Extraction Kit
MED20301
50 rcs
BRAF Standard DNA Kit
MED32001
4 x 100 ng
EGFR - Epithelial Growth Factor Receptor
Product name
RealLine EGFR Detect, L858R, Kit for real-time PCR
RealLine EGFR Detect, L858R, Kit for real-time PCR
EGFR Detect del 746-750, Kit for Standard PCR
EGFR Detect del 746-750, Kit for Standard PCR
Cat. no
Pack size
MED20501
MED20510
MED20601
MED20610
12 rcs
36 rcs
12 rcs
36 rcs
The real time PCR EGFR-L858R kit is designed to detect missense mutation CTG>CGG at
codon 858 of EGFR gene. Detection is made by allele-specific real time PCR-based assay.
The kit is designed for in vitro diagnostics and provides qualitative detection. (new line)
The EGFR-Del746-750 kit is designed to detect micro deletions in tyrosine kinase domain of
EGFR gene that correspond to 746-750 amino acids in the protein sequence.
Applications
Indications for Testing
Sample Material
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
● Patients with tumors harboring either of these mutant forms of EGFR are extremely
®
sensitive to the selective EGFR tyrosine kinase (TK) inhibitors gefitinib (IRESSA ) or
®
erlotinib (TARCEVA ).
● DNA extracted from fresh-frozen or formalin-fixed paraffin-embedded (FFPE) tumor tissue
sections can be tested.
● FAM (495-520 nm)
EGFR Mutation-L858R
● ROX (575-602 nm)
Internal Control IC
CANCER MUTATION DETECTION
CANCER MUTATION DETECTION
● Bio-Rad iQ™, iQ™5, CFX96™ (Bio- Rad, USA)
● AB 7500 (Applied Biosystems, USA)
● LightCycler® Nano System (Roche, Switzerland)
Related Products
Product name
Cat. no
Pack size
RealLine FFPE DNA Extraction Kit
MED20301
50 rcs
EGFR Standard DNA Kit, L858R
MED32201
4 x 100 ng
EGFR-ex19del standards Kit
MED32301
3 x 100 ng
EGFR standards Kit
MED32401
7 x 100 ng
www.bioron.de
47
CANCER MUTATION DETECTION
CANCER MUTATION DETECTION
KRAS
Product name
RealLine KRAS Detect, Kit for Real Time PCR
RealLine KRAS Detect, Kit for Real Time PCR
Cat. no
Pack size
MED20401
MED20410
12 rcs
36 rcs
The RealLine KRAS Detect kit is designed for the detection of 7 mutations in the codons 12
and 13 of the kRas gene by real-time PCR.
Number
Applications
Mutation, amino acid
1
G12C
2
G12S
3
G12R
4
G12V
5
G12D
6
G12A
7
G13D
* mutated nucleotide is underlined and marked in red.
Mutant codon,
nucleotides*
TGT
AGT
CGT
GTT
GAT
GCT
GAC
Indications for Testing
● Targeted therapy of metastatic colorectal cancer (mCRC)
Sample Material
● DNA extracted from fresh, fresh-frozen or formalin-fixed paraffin-embedded (FFPE) tumor
tissue section.
Real Time PCR Detection
Channels
Validated and Tested
Cyclers
● FAM (495-520 nm)
KRAS mutations
● ROX (575-602 nm)
Internal Control IC
● Bio-Rad iQ™, iQ™5, CFX96™ (Bio-Rad, USA)
● AB 7500 (Applied Biosystems, USA)
● LightCycler® Nano System (Roche, Switzerland)
Related Products
Product name
48
Cat. no
Pack size
RealLine FFPE DNA Extraction Kit
MED20301
50 rcs
KRAS Standard DNA Kit
MED32101
2 x 200 ng
Standard DNA for the Detection of Cancer Mutations
Product name
BRAF Standard DNA Kit
EGFR Standard DNA Kit, L858R
EGFR Standard DNA Kit, del 746-750
EGFR Standard DNA Kit, L858R & del 746-750
KRAS Standard DNA Kit
Cat. no
Pack size
MED32001
MED32201
MED32301
MED32401
MED32101
4 x 100 ng
4 x 100 ng
3 x 100 ng
7 x 100 ng
2 x 200 ng
DNA Standards containing the relevant KRAS, EGFR or BRAF mutations as positive
mutation control and validation for in-house protocols.
Applications
Related Products
Product name
Cat. no
Pack size
RealLine FFPE DNA Extraction Kit
MED20301
50 rcs
RealLine EGFR Detect, L858R, Kit for real-time PCR
RealLine EGFR Detect, L858R, Kit for real-time PCR
EGFR Detect del 746-750, Kit for Standard PCR
EGFR Detect del 746-750, Kit for Standard PCR
RealLine BRAF Detect V600E, Kit for Real Time PCR
RealLine BRAF Detect V600E, Kit for Real Time PCR
RealLine KRAS Detect, Kit for Real Time PCR
RealLine KRAS Detect, Kit for Real Time PCR
MED20501
MED20510
MED20601
MED20610
MED20701
MED20710
MED20401
MED20410
12 rcs
36 rcs
12 rcs
36 rcs
12 rcs
36 rcs
12 rcs
36 rcs
www.bioron.de
CANCER MUTATION DETECTION
CANCER MUTATION DETECTION
49
EXTRACTION KITS
EXTRACTION OF
KITS
DNA
Transportation Solution
Product name
Cat. no
Pack size
RealLine Transportation Solution
VBC8894
100 rcs
RealLine Transportation Solution is designed for the transportation and storage of clinical material for subsequent
detection of pathogens using real time PCR. The RealLine Transportation Solution is compatible with most DNA
extraction kits. The kit includes 100 sample tubes with 300 µl solution each.
The Transportation Solution is intended for the storage of biological samples
Specimens can be stored:
• At room temperature – up to 2 days
• At (2 – 8) °С – up to 2 weeks
• Frozen at -20 °С – up to 2 months
● Biopsies
● Urine
● Sperm
● Epithelial cells specimen from:
● Cervical mucosa
● Urethra
● Vagina
● Posterior wall of the larynx
Applications
Sample Material
RealLine DNA-Express
RealLine DNA-Express
Product name
Cat. no
Pack size
RealLine DNA-Express
VBC8899
100 rcs
Reagent kits for rapid extraction of DNA. Allows independent extraction of DNA from 100 clinical samples.
Applications
RealLine DNA-Express kit is intended for use in clinical practice in the process of
diagnostics of sexually transmitted infections (STI) or other infections.
Sample Material
● epithelial cells e.g. from the mucosa of the cervical canal, urethra, vagina
● urine
● sperm
Related Products
Product name
RealLine Transport Solution
RealLine Internal Control
50
Cat. no
Pack size
VBC8894
VBC8881
100 rcs
250 rcs
RealLine DNA - Extraction 2
Product name
Cat. no
Pack size
RealLine DNA - Extraction 2
VBC8897
96 rcs
RealLine DNA - Extraction 2 kit is intended for DNA extraction for in vitro diagnostics
analysis. Allows to perform 4 independent extraction procedures of 24 samples per batch
Applications
● Whole blood, serum, plasma
● Blood serum, plasma
● Biopsy material
● Liquor
● Urine
● Epithelial cells specimens
Sample Material
EXTRACTION KITS
EXTRACTION
OF KITS
DNA
EXTRACTION
RealLine DNA - Extraction 3
Product name
Cat. no
Pack size
RealLine DNA - Extraction 3
VBC8889
96 rcs
Applications
Sample Material
RealLine DNA - Extraction 3 kit is intended for DNA extraction on a magnetic rack for in
vitro diagnostics analysis. Allows to perform 6 independent extraction procedures of 16
samples per batch (including controls).
● Blood serum, plasma
● Urine
● Sperm
● Epithelial cells specimens
Related Products
Product name
RealLine Transport Solution
RealLine Magnetic Rack
Cat. no
Pack size
VBC8894
VBE9258 or VBE9291
100 rcs
1 unit
www.bioron.de
51
EXTRACTION KITS
EXTRACTION OF
KITS
DNA & RNA
RealLine Extraction 100 and 100 (A)
Product name
Cat. no
Pack size
RealLine Extraction 100, CE - IVD
RealLine Extraction 100 (A)
VBC8896
VBC8883
48 rcs
96 rcs
RealLine Extraction 100 and 100 (A) are reagent kits for the extraction of DNA and RNA
of 100 µl of clinical samples and optimised for use together with the RealLine kits. This
extraction kit is designed for the simultaneous extraction of DNA and RNA from most
clinical samples.
RealLine Extraction 100A is optimized for the use in automatic systems.
Applications
● Whole blood, serum, plasma
● Biopsy material
● Fluid
● Urine
● Tick suspension
● Epithelial cell scrapings
Sample Material
RealLine Extraction 1000
Product name
RealLine Extraction 1000
Applications
Sample Material
Cat. no
Pack size
VBC8895
48 rcs
RealLine Extraction 1000 is a reagent kit for the extraction of nucleic acids (DNA and
RNA) of pathogens from blood serum (plasma). This kit is designed for the extraction of
DNA and RNA from higher volumes (up to 1ml) to achieve high sensitive results and is
intended for use together with the RealLine kits.
● Whole blood
● serum
● plasma
Related Products
Product name
RealLine Transport Solution
RealLine Magnetic Rack
52
Cat. no
VBC8894
VBE9258 or VBE9291
Pack size
100 rcs
1 unit
RealLine FFPE DNA Extraction Kit
Product name
RealLine FFPE DNA Extraction
RealLine FFPE DNA Extraction Mag
RealLine FFPE DNA Extraction Mag
Cat. no
Pack size
MED20301
MED32501
MED32502
50 rcs
12 rcs
36 rcs
The RealLine FFPE DNA – Extraction Kit is designed for extraction and purification of genomic DNA from
formalin-fixed and paraffin-embedded (FFPE) tissue. The methods are fast and provide high DNA recovery
particularly critical for small biopsies. Purified DNA can be used in PCR and real-time PCR.
Applications
Indications for Testing
Sample Material
Kit for the extraction of formalin-fixed paraffin embedded tissue (FFPE). The kit can be used
for difficult and small sections of cancer tissue with a very high efficiency for the extractions
of DNA.
Patients with tumors harboring from mutant forms of EGFR, KRAS, BRAF
Other tumors for testing of mutant genes
EXTRACTION KITS
EXTRACTION
OF KITS
DNA
EXTRACTION
● Sections of formalin-fixed paraffin-embedded (FFPE) tissue can be used for DNA
extraction.
Related Products
Product name
Cat. no
Pack size
RealLine BRAF Detect V600E, Kit for Real Time PCR
RealLine BRAF Detect V600E, Kit for Real Time PCR
BRAF Standard DNA Kit
MED20701
MED20710
MED32001
12 rcs
36 rcs
4 x 100 ng
RealLine EGFR Detect, L858R, Kit for real-time PCR
RealLine EGFR Detect, L858R, Kit for real-time PCR
EGFR Detect del 746-750, Kit for Standard PCR
EGFR Detect del 746-750, Kit for Standard PCR
EGFR Standard DNA Kit, L858R
MED20501
MED20510
MED20601
MED20610
MED32201
12 rcs
36 rcs
12 rcs
36 rcs
4 x 100 ng
EGFR-ex19del standards Kit
MED32301
3 x 100 ng
EGFR standards Kit
MED32401
7 x 100 ng
RealLine KRAS Detect, Kit for Real Time PCR
RealLine KRAS Detect, Kit for Real Time PCR
KRAS Standard DNA Kit
MED20401
MED20410
MED32101
12 rcs
36 rcs
2 x 200 ng
www.bioron.de
53
PCR-KITS FOR PATHOGEN DETECTION
OVERVIEW TABLES
Overview: purpose and use of the RealLine Extraction Kits
Product
Cat.no.
Clinical Material
Extraction Detection of
of
RealLine DNA-Express
CE-IVD
RealLine DNA-Extraction 2
CE-IVD
RealLine DNA-Extraction 3
CE-IVD
RealLine Extraction 100
CE-IVD
RealLine Extraction 100A
(for automation)
54
Rcs
100
96
VBC8899
epithelial cell
specimen,
urine,
sperm,
saliva
VBC8897
epithelial cell
specimen,
urine,
liquor,
biopsy material,
blood serum/plasma
VBC8889
epithelial cell
specimen,
urine
blood serum/plasma
96
48
VBC8896
VBC8883
96
RealLine Extraction 1000
RUO
48
VBC8895
RealLine FFPE DNA
Extraction Kit
RUO
50
MED20301
epithelial cell
specimen,
liquor
biopsy material
blood serum/plasma
blood serum/plasma
Formalin-fixed and
embedded tissue
(FFPE tissue)
DNA
DNA
DNA
Sexually Transferred
Diseases
Human Herpes Viruses
HPV types
Parvovirus B19
Helicobacter pylori
and most other pathogens
Sexually Transferred
Diseases
Human Herpes Viruses
HPV types
Parvovirus B19
Borrelia and Anaplasma
RNA
and
DNA
Sexually Transferred
Diseases
Toxoplasma gondii
Rubella,
Borrelia, TBEV, Anaplasma
Human Herpes Viruses;
HPV types
Parvovirus B19
HIV, HCV, HBV
RNA
and
DNA
HIV, HCV, HBV
Borrelia, TBEV
DNA
KRAS, BRAF, EGFR
OVERVIEW
INTRODUCTION
TABLES
Cyclers tested with the RealLine Kits
Tested Cyclers
Bio-Rad
iQ™ + iQ5™ iCycler
CFX96™
Qiagen
Rotor-Gene® 3000
Rotor-Gene® 6000
DNA-Technology
DT-Prime
DT-Lite
Illumina
Eco Real Time PCR Cycler
Roche
LightCycler® 1.5-2.0
LightCycler® 480 I+II
LightCycler® Nano System
Applied Biosystems
ABI 7500
ABI 7300
Eppendorf
Mastercycler
Recommended Kit Formats
Str-format and Fla-format
Str-format and Fla-format
Fla-format
Fla-format
Str-format and Fla-format
Str-format and Fla-format
Fla-format
Fla-format and Uni-format
Fla-format and Uni-format
Fla-format and Uni-format
Fla-format and Str-format
Fla-format and Str-format
Str-format and Fla-format
For the recommended formats please see ‟Different formats for different cyclers” on page 6.
Comments:
The RealLine kits are designed for the use with block cyclers iQ™ iCycler, iQ5™ iCycler, CFX96™
(Bio-Rad, USA), DT96 (DNA-Technology Research and Production Company ZAO, Russia); rotor type
cyclers Rotor-Gene® 3000, Rotor-Gene® 6000 and Rotor-Gene® Q (Qiagen, Germany),
The use of
- other suppliers' Extraction Kits for nucleic acids from clinical specimens
- other real-time PCR devices
- appropriate reaction volumes, other than the volumes indicated in the protocols
have to be validated in the laboratory by the user.
Special notes regarding the Internal Control IC must be followed stringently.
www.bioron.de
55
PCR-KITS FOR PATHOGEN DETECTION
OVERVIEW TABLES
Available Samples of the RealLine Pathogen Kits
Cat.no.
RealLine Extraction 100
SVBC8896
12
VBC8896
DNA and RNA Extraction
RealLine Extraction 1000
SVBC8895
12
VBC8895
DNA and RNA Extraction
RealLine DNA - Extraction 2
SVBC8897
24
VBC8897
DNA Extraction
RealLine DNA - Extraction 3
SVBC8889
24
VBC8889
DNA Extraction
RealLine DNA- Express
SVBC8899
30
VBC8899
DNA Extraction
RealLine Internal control
SVBC8881
50
VBC8881
Internal Control
RealLine Transportation Solution
SVBC8894
30
VBC8894
Transportation Solution
SVBD0195
12
VBD0199
VBD0195
HIV quantitative
SVBD0196
12
VBD0198
VBD0196
HIV qualitative
SVBD0595
12
VBD0599
VBD0595
HBV quantitative
SVBD0596
12
VBD0598
VBD0596
HBV qualitative
RealLine HCV quantitative (Str-format)
Matching Extraction: RealLine Extraction 100 (SVBC8896)
SVBD0794
12
RealLine HCV qualitative (Str-format)
Matching Extraction: RealLine Extraction 100 (SVBC8896)
SVBD0795
12
RealLine HSV 1, 2 (Str-format)
Matching Extraction: RealLine DNA- Extraction 3
(SVBC8889)
SVBD2193
24
RealLine HIV quantitative (Str-format)
Matching Extraction: RealLine Extraction 100 (SVBC8896)
RealLine HIV qualitative (Str-format)
Matching Extraction: RealLine Extraction 100 (SVBC8896)
RealLine HBV quantitative (Str-format)
Matching Extraction: RealLine Extraction 100 (SVBC8896)
RealLine HBV qualitative (Str-format)
Matching Extraction: RealLine Extraction 100 (SVBC8896)
RealLine HSV 1, 2 (Fla-format)
Matching Extraction: RealLine DNA- Extraction 3
(SVBC8889)
RealLine HPV High Risk, Genotype qualitative (Strformat)
Matching Extraction Kit: RealLine DNA- Extraction 3
(SVBC8889)
RealLine HPV High Risk, Genotype quantitative (Strformat)
Matching Extraction: RealLine DNA- Extraction 3
(SVBC8889)
RealLine Mycobacterium tuberculosis (Uni-format) incl.
Extraction
RealLine TBEV (Str-format)
56
Rcs
Sample method is comparable to the
following catalogue numbers/ kits
Available Samples
SVBD2194
30
SVBD8479
24
VBD0799
VBD0797
VBD0794
VBD0798
VBD0793
VBD0795
VBD2195
VBD2185
VBD1598
VBD2198
VBD2150
VBD2148
VBD2193
VBD2197
VBD2187
VBD1596
VBD2196
VBD2151
VBD2149
VBD2194
HCV quantitative
HCV qualitative
Herpes Virus Family
HSV, EBV, HHV, VZV,
CMV
VBD8482
VBD8479
HPV Genotypes
SVBD8478
24
VBD8478
SVBD2398
12
VBD2398
TBC Tuberculosis
SVBD1198
12
VBD2598
TBEV; Rubella
OVERVIEW
INTRODUCTION
TABLES
Available Samples
Cat.no.
Rcs
Matching Extraction: RealLine Extraction 100 (SVBC8896)
RealLine TBEV (Fla-format)
Matching Extraction Kit: RealLine Extraction 100
(SVBC8896)
VBD1198
SVBD1199
20
RealLine Borrelia burgdorferi (Str-format)
Matching Extractions: RealLine Extraction 100 (SVBC8896)
or RealLine DNA Extraction 3 (SVBC8889)*
SVBD1498
12
RealLine Borrelia burgdorferi s.l. (Fla-format)
Matching Extractions: RealLine Extraction 100 (SVBC8896)
or RealLine DNA Extraction 3 (SVBC8889)*
SVBD1499
20
RealLine Chlamydia trachomatis (Str-format)
Matching Extractions: RealLine DNA- Extraction 3
(SVBC8889) or RealLine DNA-Express (SVBC8899)*
SVBD1998
24
RealLine Chlamydia trachomatis (Fla-format)
Matching Extractions: RealLine DNA- Extraction 3
(SVBC8889) or RealLine DNA-Express (SVBC8899)*
SVBD1996
30
RealLine Trichomonas / Neisseria (Str-format)
Matching Extraction Kit: RealLine DNA- Extraction 3
(SVBC8889) or RealLine DNA-Express (SVBC8899)*
SVBD0496
24
RealLine Trichomonas / Neisseria (Fla-format)
Matching Extraction Kit: RealLine DNA- Extraction 3
(SVBC8889) or RealLine DNA-Express (SVBC8899)*
Sample method is comparable to the
following catalogue numbers/ kits
SVBD0495
30
VBD2596
VBD1199
VBD3798
VBD5398
VBD1798
VBD2801
VBD1498
VBD3796
VBD5399
VBD1796
VBD1499
VBD1998
VBD2098
VBD2298
VBD4396
VBD4398
VBD4498
VBD4598
VBD4698
VBD1996
VBD2096
VBD2296
VBC4394
VBD4393
VBD4496
VBD4596
VBD4696
VBD0490
VBD0492
VBD0498
VBD0494
VBD2294
VBD0444
VBD8473
VBD8471
VBD8469
VBD8465
VBD8464
VBD8475
VBD0496
VBD0477
VBD0491
VBD0497
VBD0487
VBD0493
VBD2295
VBD0445
VBD8474
VBD8480
VBD8477
VBD8463
VBD8461
VBD8481
VBD0495
VBD0478
Borrelia,
Anaplasma/Ehrlichia,
Helicobacter, Parvovirus
B19 and Toxoplasma
STI (sexually transferred
diseases)
STI Double Kits
HPV Double Kits
www.bioron.de
57
OVERVIEW TABLES
Certification Status
PCR KITS FOR PATHOGEN DETECTION
58
Sexually Transmitted Infections (STI)
RealLine Candida albicans (Str-format)
RealLine Candida albicans (Fla-format)
VBD4698
VBD4696
CE-IVD
CE-IVD
RealLine Chlamydia trachomatis (Str-format)
RealLine Chlamydia trachomatis (Fla-format)
VBD1998
VBD1996
CE-IVD
CE-IVD
RealLine Gardnerella vaginalis (Str-format)
RealLine Gardnerella vaginalis (Fla-format)
VBD4598
VBD4596
CE-IVD
CE-IVD
RealLine Mycoplasma genitalium (Str-format)
RealLine Mycoplasma genitalium (Fla-format)
VBD4396
VBD4394
CE-IVD
CE-IVD
RealLine Mycoplasma hominis (Str-format)
RealLine Mycoplasma hominis (Fla-format)
VBD4398
VBD4393
CE-IVD
CE-IVD
RealLine Neisseria gonorrhoeae (Str-format)
RealLine Neisseria gonorrhoeae (Fla-format)
VBD4498
VBD4496
CE-IVD
CE-IVD
RealLine Trichomonas vaginalis (Str-format)
RealLine Trichomonas vaginalis (Fla-format)
VBD2098
VBD2096
CE-IVD
CE-IVD
RealLine Ureaplasma urealyticum (Str-format)
RealLine Ureaplasma urealyticum (Fla-format)
VBD2298
VBD2296
CE-IVD
CE-IVD
STI Multiplexing Kits
RealLine Candida / Gardnerella (Str-format)
RealLine Candida / Gardnerella (Fla-format)
VBD0444
VBD0445
CE-IVD
CE-IVD
RealLine Chlamydia / Ureaplasma urealyticum (Str-format)
RealLine Chlamydia / Ureaplasma urealyticum (Fla-format)
VBD0492
VBD0491
RUO
RUO
RealLine Chlamydia / Neisseria (Str-format)
RealLine Chlamydia / Neisseria (Fla-format)
VBD0457
VBD0458
RUO
RUO
RealLine Chlamydia / Trichomonas (Str-form)
RealLine Chlamydia / Trichomonas (Fla-format)
VBD0498
VBD0497
RUO
RUO
RealLine Chlamydia / Mycoplasma genitalium (Str-format)
RealLine Chlamydia / Mycoplasma genitalium (Fla-format)
VBD0490
VBD0487
RUO
RUO
RealLine Mycoplasma hominis/ genitalium (Str-format)
RealLine Mycoplasma hominis/ genitalium (Fla-format)
VBD0494
VBD0493
CE-IVD
CE-IVD
OVERVIEW
INTRODUCTION
TABLES
RealLine Ureaplasma urealyticum/ parvum (Str-format)
RealLine Ureaplasma urealyticum/ parvum (Fla-format)
VBD2294
VBD2295
CE-IVD
CE-IVD
RealLine Trichomonas / Neisseria (Str-format)
RealLine Trichomonas / Neisseria (Fla-format)
VBD0496
VBD0495
CE-IVD
CE-IVD
RealLine Trichomonas / Gardnerella (Str-format)
RealLine Trichomonas / Gardnerella (Fla-format)
VBD0477
VBD0478
CE-IVD
CE-IVD
Human Papilloma Virus (HPV)
RealLine HPV 16 / 18 (Str-format)
RealLine HPV 16 / 18 (Fla-format)
VBD8473
VBD8474
CE-IVD
CE-IVD
RealLine HPV 31 / 33 (Str-format)
RealLine HPV 31 / 33 (Fla-format)
VBD8471
VBD8480
CE-IVD
CE-IVD
RealLine HPV 35 / 45 (Str-format)
RealLine HPV 35 / 45 (Fla-format)
VBD8469
VBD8477
CE-IVD
CE-IVD
RealLine HPV high carcinogenic risk, Genotype (Str-format)
RealLine HPV high carcinogenic risk, Genotype (Fla-format)
VBD8479
VBD8482
CE-IVD
CE-IVD
RealLine HPV high carcinogenic risk, Genotype, quant. (Strformat)
VBD8478
Mycobacterium tuberculosis (TB)
RealLine Mycobacterium tuberculosis (Uni-format) incl.
extraction
RealLine Mycobacterium tuberculosis (Str-format)
VBD2398
CE-IVD
CE-IVD
CE-IVD
Human Herpes Viruses (HHV)
RealLine CMV (Str-format)
RealLine CMV (Fla-format)
VBD1598
VBD1596
CE-IVD
CE-IVD
RealLine EBV (Str-format)
RealLine EBV (Fla-format)
VBD2198
VBD2196
CE-IVD
CE-IVD
RealLine HSV-1/ HSV-2
RealLine HSV-1/ HSV-2
VBD2195
VBD2197
CE-IVD
CE-IVD
RealLine HHV - 6 (Str-format)
RealLine HHV - 6 (Fla-format)
VBD2150
VBD2151
CE-IVD
CE-IVD
RealLine HHV - 8 (Str-format)
RealLine HHV - 8 (Fla-format)
VBD2148
VBD2149
CE-IVD
CE-IVD
RealLine VZV (Str-format)
RealLine VZV (Fla-format)
VBD2185
VBD2187
CE-IVD
CE-IVD
www.bioron.de
59
PCR-KITS FOR PATHOGEN DETECTION
OVERVIEW TABLES
60
Tick Borne Infections
RealLine TBEV (Str-format)
RealLine TBEV (Fla-format)
VBD1198
VBD1198
VBD1199
CE-IVD
CE-IVD
CE-IVD
RealLine Borrelia burgdorferi s.l. (Str-format)
RealLine Borrelia burgdorferi s.l. (Fla-format)
VBD1498
VBD1499
CE-IVD
CE-IVD
RealLine Anaplasma / Ehrlichia (Str-format)
RealLine Anaplasma / Ehrlichia (Fla-format)
VBD5398
VBD5399
CE-IVD
CE-IVD
Rubella
RealLine Rubella (Str-format)
RealLine Rubella (Fla-format)
VBD2598
VBD2596
CE-IVD
CE-IVD
Toxoplasma
RealLine Toxoplasma gondii (Str-format)
RealLine Toxoplasma gondii (Fla-format)
VBD1798
VBD1796
CE-IVD
CE-IVD
Parvovirus B19
RealLine Parvovirus B19 (Str-format)
RealLine Parvovirus B19 (Fla-format)
VBD2801
VBD2802
RUO
RUO
Helicobacter pylori
RealLine Helicobacter pylori (Str-format)
RealLine Helicobacter pylori (Fla-format)
VBD3798
VBD3796
CE-IVD
CE-IVD
HIV (Human Immunodeficency Virus)
RealLine HIV qualitative (Uni-format) incl. extraction
RealLine HIV quantitative (Uni-format) incl. extraction
VBD0198
VBD0199
RUO
RUO
RealLine HIV quantitative (Str-format),
RealLine HIV qualitative (Str-format)
VBD0195
VBD0196
RUO
RUO
HCV (Hepatitis C Virus)
RealLine HCV qualitative (Uni-format), incl. extraction
RealLine HCV quantitative (Uni-format), incl. extraction
VBD0798
VBD0799
RUO
RUO
RealLine HCV qualitative (Str-format)
RealLine HCV quantitative (Str-format)
VBD0795
VBD0794
RUO
RUO
RealLine HCV Genotype qualitative (Uni-format)
RealLine HCV Genotype quantitative (Str-format)
VBD0793
VBD0797
RUO
RUO
HBV (Hepatitis B Virus)
RealLine HBV qualitative (Uni-format) incl. extraction
RealLine HBV quantitative (Uni-format), incl. extraction
VBD0598
VBD0599
RUO
RUO
RealLine HBV, qualitative (Str-format)
RealLine HBV, quantitative (Str-format)
VBD0596
VBD0595
RUO
RUO
SUPPLEMENTARY PRODUCTS
RealLine Internal Control (2 x 2 ml)
VBC8881
RUO
RealLine Magnetic Rack
RealLine Magnetic Rack with exchangeable covers
VBE9258
VBE9291
OVERVIEW
INTRODUCTION
TABLES
KITS FOR CANCER RELATED MUTATIONS ANALYSIS
BRAF
RealLine BRAF Detect, V600E, Kit for real-time PCR
RealLine BRAF Detect, V600E, Kit for real-time PCR
BRAF Standard DNA Kit
MED20701
MED20710
MED32001
RUO
RUO
RUO
EGFR
RealLine EGFR Detect, L858R, Kit for real-time PCR
RealLine EGFR Detect, L858R, Kit for real-time PCR
EGFR Detect del 746-750, Kit for Standard PCR
EGFR Detect del 746-750, Kit for Standard PCR
RealLine EGFR Detect, L858R, Kit for real-time PCR
RealLine EGFR Detect, L858R, Kit for real-time PCR
EGFR Detect del 746-750, Kit for Standard PCR
MED20501
MED20510
MED20601
MED20610
MED20501
MED20510
MED20601
RUO
RUO
RUO
RUO
RUO
RUO
RUO
KRAS
RealLine KRAS Detect, DNA for real-time PCR
RealLine KRAS Detect, Kit for real-time PCR
KRAS Standard DNA Kit
MED20401
MED20410
MED32101
RUO
RUO
RUO
KITS FOR EXTRACTION OF NUCLEIC ACIDS
Transportation solution
VBC8894
CE-IVD
RealLine DNA - Express
VBC8899
CE-IVD
RealLine DNA - Extraction 2
RealLine DNA - Extraction 3
VBC8897
VBC8889
CE-IVD
CE-IVD
RealLine Extraction 100
RealLine Extraction 100 (A)
RealLine Extraction 1000
VBC8896
VBC8883
VBC8895
CE-IVD
RUO
RUO
RealLine FFPE DNA Extraction Kit
RealLine FFPE DNA Extraction Mag
RealLine FFPE DNA Extraction Mag
MED20301
MED32501
MED32502
RUO
RUO
RUO
For RealLine Kits which are marked with RUO*, certification is still in process
www.bioron.de
61
ALPHABETICAL LIST OF PRODUCTS
Alphabetical Product List
A
Anaplasma phagocytophilum page
RealLine Pathogens
34
RealLine Pathogens
46
35
RealLine Pathogens
RealLine Pathogens
RealLine Pathogens
RealLine Pathogens
RealLine Cancer
RealLine Cancer
8, 16
9, 17
28
28
45
45
RealLine Extraction
50
RealLine Pathogen
RealLine Cancer
RealLine Pathogen
RealLine Pathogen
RealLine Extraction
RealLine Pathogen
29
47
34
34
50
29
RealLine Extraction
53
RealLine Pathogen
10, 16
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
RealLine Pathogen
40
30
25
28
41
42
43
41
42
43
25
30
31
RealLine Pathogen
RealLine Extractions
6, 44
6, 44
B
Borrelia burgdorferi s.l. BRAF RealLine Cancer
C
Candida albicans Chlamydia trachomatis Cytomegalovirus (CMV) CMV
Cancer Colorectal cancer D
DNA
E
EBV EGFR
Ehrlichia muris Ehrlichia chaffeensis Extraction DNA/RNA Eppstein Barr Virus (EBV) F
FFPE G
Gardnerella vaginalis H
Helicobacter pylori Herpes Simplex Virus 1&2 (HSV 1,2) Human Papilloma Virus (HPV) Human Herpes Viruses (HHV) Human Immunodeficiency Virus (HIV) Herpes C Virus (HCV) Herpes B Virus (HBV) HIV HCV HBV HPV HSV HHV I
Internal Control (IC) IC
62
ALPHABETICAL LISTINTRODUCTION
OF PRODUCTS
K
KRAS
RealLine Cancer
48
RealLine Cancer
47
RealLineSupplementory Products
RealLine Pathogens
RealLine Pathogens
RealLine Pathogens
RealLine Extractions
RealLine Cancer Mutation 44
11
12
27
50
45
Neisseria gonorrhoeae
RealLine Pathogen
13
Oncogenes
R
Rubella
RNA
RealLine Cancer 45
RealLine Pathogens
RealLine Extractions
37
52
RealLine Pathogens
RealLine Pathogens
8, 16
8, 16
RealLine Extractions
RealLine Pathogens
RealLine Pathogens
RealLine Pathogens
50
14
34
36
RealLine Pathogens
RealLine Cancer
15
45
RealLine Pathogens
RealLine Pathogens
33
33
L
Lung cancer
M
Magnetic rack
Mycoplasma genitalium
Mycoplasma hominis
Mycobacterium tuberculosis
Magnetic beads
Melanoma
N
O
S
STI
Sexually Transmitted Diseases (STI)
T
Transport Solution
Trichomonas vaginalis
Tick-Borne- Encephalitis Virus (TBEV)
TBEV
U
Ureaplasma urealyticum
Tumor
V
Varicella Zoster Virus (VZV)
VZV
www.bioron.de
63
CONDITION OF SALES
General terms and conditions of BIORON Diagnostics GmbH
I
General information
Scope Warning
1. Deliveries and performance from BIORON Diagnostics shall be executed solely in accordance with the following standard terms of contract. These standard terms of contract shall apply to
transactions conducted with businessmen and entrepreneurs in compliance with § 14 BGB (Federal Statutes at Large). These standard terms of contract shall apply to all future transactions
between the partners to the agreement, without special further reference. They shall also apply to future agreements even if BIORON Diagnostics does not explicitly quote the terms, in particular when BIORON Diagnostics having knowledge of alternative terms of purchase or of terms deviating from the standard terms of delivery or performance stipulated in the contract. You
have already been notified of the standard terms of contract by means of our standard forms as well as via e-mail messages and publications in the Internet. The scope of application of these
standard terms of contract shall also be valid in all supplier countries
2. BIORON Diagnostics products are exclusively designed for application within the research and laboratory sector. A usage in connection with persons, animals, in households or in other forms
of private use is forbidden. The application of the products in the diagnostic or therapeutic sector is forbidden. The resale of BIORON Diagnostics products to private individuals is not permitted.
BIORON Diagnostics shall not be liable for damage to objects or injury to persons caused by improper application, treatment or storage. We draw special attention to the regulations stated in
Sections VII. to IX. Unless explicitly stated, no licence or immunity under any patent is either granted or implied by the sale of any of our products. BIORON Diagnostics does not warrant that
the resale or use of its products delivered will not infringe the claims of any patents, trademarks or copyright covering use of the product itself, or its use in combination with any other products,
or its use in the operation of any process. Furthermore, the purchaser assumes all risks of patent, trademark or copyright infringement associated with any such use, combination or operation.
3. Some of the BIORON Diagnostics products may be toxic or hazardous and are therefore designated as such in compliance with the statutory regulations. An omission of safety hazard warnings
on the labels of BIORON Diagnostics products does not mean that the respective product is harmless. BIORON Diagnostics also draws special attention to the regulations defined in Sections
VII. to IX here.
4. BIORON Diagnostics has the intent to supply solely to commercial enterprises, public research-, analytical laboratories and educational facilities. Customers who do not belong to this specified
clientele shall be obliged to provide BIORON Diagnostics with information pertaining to the status and/or business operations of their company res. person on establishment of contact res.
placement of order. If the relevant information is not furnished, BIORON Diagnostics shall be exempted from any liability resulting thereof. BIORON Diagnostics shall be entitled to reject orders
if there is a possibility that their products may be used in an unauthorized manner.
II
Tenders and Conclusion of Agreement
Performance
1. BIORON Diagnostics tenders to the prospective customer shall be subject to confirmation. The placing of an order by the customer shall be binding. The acceptance of the order will follow within
four (4) weeks by means of the dispatching of a confirmation of order or unconditional execution of the consigned deliveries or performance.
2. The technical data and descriptions in the respective product information or advertising material from BIORON Diagnostics shall not present a guarantee for the quality or durability of goods
delivered or supplied by BIORON Diagnostics. Warranties will not be furnished unless these have been explicitly agreed upon in separate contracts.
3. In connection with the above mentioned Paragraph 2 BIORON Diagnostics draws particular attention to the fact that BIORON Diagnostics gives all information related to the origin, state, nature,
condition, quality and the manufacturing process of the primary product and.In this context, BIORON Diagnostics is mostly depending and relying on the information, promises, assurances,
confirmations and certificates provided by its suppliers. BIORON Diagnostics at its stage of production is not able to conduct extensive product testing with all products. As for these reasons it
is not possible to trace back in every single case, BIORON Diagnostics denies all liability in that respect.
4. In the case of sales in accordance with samples or specimens, this shall merely describe the professional compliance with the sample or specimen, but shall not be a guarantee for the composition or durability of the goods to be delivered by BIORON Diagnostics or the performance to be executed.
III Prices
Terms of payment
Default of payment
1. The prices determined by the conclusion of the respective agreement, in particular the prices stipulated in the order form res. the confirmation of order in EURO shall be valid. If a price is not
explicitly defined, the prices, which are valid at the time when the agreement is concluded in accordance with the current BIORON Diagnostics price list, should be valid. The statutory valueadded tax valid on the day of delivery shall be added to the defined prices.
2. The products shall be delivered ex factory. The prices shall include the costs of packaging required for the regular shipment of goods together with the reimbursement for the disposal of the
sales-, and transport packaging. The prices do not include transport costs or costs for a transportinsurance, if this has not been previously agreed upon. The terms of packaging and transport
must be concluded separately for goods to be delivered abroad.
3. BIORON Diagnostics shall reserve the right to modify prices in a reasonable manner if alterations in costs e.g. due to wage settlements, price increases by suppliers, fluctuations in the monetary
exchange rates or other important reasons should arise after the conclusion of the agreement.
4. Invoices received from BIORON Diagnostics must be paid within ten days from receipt of the invoice minus two percent (2%) discount, if no other terms have been concluded. The customer
shall be in default of payment after the expiry of the settlement date stated in the invoice in compliance with § 286 Section 2 No. 2 BGB (Federal Statutes at Large). In compliance with § 288
BGB (Federal Statutes at Large) default interest will be calculated from the day of expiry of the settlement date with reservation to assertion of further claims.
5. The customer may only exercise the option of offsetting or retention if his counter-claims have been legally justified and BIORON Diagnostics have neither recognized nor disputed the claims
within two (2) weeks of notification.
6. If the customer should not pay invoices due, after the term of credit has expired, or if the financial circumstances of the customer should deteriorate following the conclusion of the agreement or
if BIORON Diagnostics should receive unfavorable information pertaining to the customer that queries the solvency of the customer, BIORON Diagnostics shall be justified in taking measures
to procure the entire residual amount from the customer and via an amendment of the payment terms concluded advance payment or collateral security or immediate settlement of all its claims.
This shall apply, in particular, if the customer does not meet his payments, or a cheque from the customer is dishonoured, a bill of draft furnished by the customer shall not be redeemed, a
bankruptcy process relating to the assets of the customer has been petitioned or initiated or when insolvency proceedings have not been initiated due to insufficient assets.
IV Time of delivery and performance
Default
1. The validity of delivery schedule shall be considered roughly stated if a fixed delivery date has not been concluded in writing. However, when BIORON Diagnostics has exceeded determined
delivery schedules due to justifiable circumstances, the customer shall have the option to withdraw from the agreement after an additional respite following the fruitless expiry of a reasonable
period stated by the customer. The withdrawal from the agreement must be furnished in writing.
2. BIORON Diagnostics shall only be in default following the expiry of a reasonable additional respite of time. In cases of Force Majeure (Act of God) and other unforeseeable, extraordinary circumstances, which cannot be influenced by BIORON Diagnostics such as like disturbance in operation as a result of fire, water and similar circumstances, breakdown of production systems and
machinery, exceeding the term of delivery or failure to deliver on the part of suppliers together with interruptions in operation due to a shortage of raw materials, energy or working force, strikes,
shut-out, problems with the acquisition of transport, traffic disturbance, official administrative measures, BIORON Diagnostics – as far as BIORON Diagnostics is hindered to fulfil its obligations
not due to its own fault – shall be entitled to postpone delivery or performance until the extraordinary circumstances have been alleviated and shall be granted a reasonable respite. If delivery
or performance should be delayed by more than two months hereby, both BIORON Diagnostics and the customer shall be entitled to furnish written notice of withdrawal from the agreement
under the ruling out of claims to indemnification with regard to the bulk amount influenced by the disturbance in delivery.
3. In every case of default the liability of BIORON Diagnostics to pay compensation is limited by the stipulation of the regulations in Section VIII No. 1 to 6.
4. BIORON Diagnostics is entitled to furnish partial deliveries or performance within the scope of the agreed times of delivery and performance if this is acceptable to the customer.
V Passing of risk
Handling of packaging
1. Risk and costs shall pass to the customer upon shipment in so far as no deviating provisions have been defined. The risk of accidental perishing, loss or destruction and of incidental deterioration
of the object of delivery passes to the customer on surrender of the consignment to the haulage company (even in the case of deliveries which have been insured against transport damage by
BIORON Diagnostics).
2. Packaging and containers may not be used for other purposes or for storage of other products. They are exclusively intended for the transport of goods delivered by BIORON Diagnostics.
Labels may not be removed. BIORON Diagnostics will not take one-way packaging back. The customer must dispose of this packaging in the authorized manner. In particular it must be ensured
that emptied containers must not be employed for the storage of other materials. The disposal costs have been included into our prices by means of a corresponding compensation (Section
III. Paragraph 2., Regulation 2). If another deviating provision has been concluded, BIORON Diagnostics shall inform the customer or a third party who will accept the packaging in accordance
with the statutory legislation pertaining to packaging disposal in return for reasonable remuneration.
VI Customer obligations
Reservation of title
1. BIORON Diagnostics shall retain title to the delivered products until the entire payment of the purchase price and all pending additional, current or future demands resulting from business
relations with the customer has been settled. The settlement of the in an outstanding invoice and the acceptance of the balance of another invoice shall not affect the reservation of title.
2. The customer shall be obliged to treat the purchased goods carefully, in particular he shall be obliged to insure the goods with the cost price against loss and damage and destruction, e.g.
against damage caused by fire, water and theft at his own costs. The customer shall cede his claims resulting from the insurance policies to BIORON Diagnostics at once. BIORON Diagnostics
shall accept the assignment of the claims herewith.
3. The customer may neither pledge nor give as a security the goods for which BIORON Diagnostics has the reservation of title. However, he shall be entitled to sell the delivered goods within the
scope of a correct business transaction in accordance with the following terms. The previously mentioned justification shall not hold in as far as the customer transfers or pledges claims against
his contractual partner, resulting from the resale of the goods, to a third party or has concluded an effective prohibition of assignment in advance.
4. The customer shall immediately assign to BIORON Diagnostics all – including future and contingent – accounts receivable to be acquired from a resale of the goods delivered by BIORON
Diagnostics for the securing of the fulfilment of claims dealt with in Section VI No. 1 together with all ancillary rights at a sum of 110% gross of the value of the delivered goods which will take
precedence over the residual sum of his accounts receivable. BIORON Diagnostics shall accept the assignment herewith.
64
CONDITION
INTRODUCTION
OF SALES
5. As long as and as far as the customer settles his payment obligations to BIORON Diagnostics, he shall be entitled to the collection of claims assigned to BIORON Diagnostics within the scope
of the regular management. However, he shall not be entitled to conclude an current accounts agreement to a third party or prohibition of assignment with his customers in relation to these
claims or to transfer or pledge these to third parties. If in contrast to regulation 2 a current account agreement should exist between the customer and the purchaser of BIORON Diagnostics’s
reservation goods, the previously assigned claim shall also relate to the accepted balance as well as to the existing balance in the case of insolvency of the purchaser.
6. On demand of BIORON Diagnostics the customer shall be required to establish the accounts receivable which he has assigned to BIORON Diagnostics separately and to notify his debtors of
the assignment with the request to pay all outstanding invoices to BIORON Diagnostics up to the value of the claims to the customer. BIORON Diagnostics shall be entitled to notify the debtors
of this arrangement at any time and to collect the claims, if necessary. However BIORON Diagnostics will only make use of this authorization if the customer fails to meet his financial obligations
or is in default, or when an insolvency process has been initiated against the customer, or the customer ceases to pay the invoices. If one of the aforementioned cases should arise, BIORON
Diagnostics can demand that the customer notifies BIORON Diagnostics of the assigned claims and the debtors thereof in detail and furnishes all relevant information pertaining to the collection
of the accounts receivable and hands over the respective documents.
7. In the case of seizures or any other interference of third parties, the customer shall immediately (without undue delay) inform BIORON Diagnostics in writing in order to enable BIORON Diagnostics to react in an appropriate manner and, if necessary, to bring an action according to § 771 Code of Civil Procedure.
8. BIORON Diagnostics shall be obliged to release all securities furnished by the customer, if he requires, in the event when realisable value of the securities should exceed BIORON Diagnostics’s
account receivables from the customer by more than twenty percent (20%).
9. In the case of customer behaviour which is contrary to the terms of the agreement, in particular in the case of default of payment exceeding ten percent (10%) of the balance due for a not
insignificant period of time, BIORON Diagnostics – irrespective of further outstanding or pending (compensation) claims – shall be entitled to withdraw from the agreement and demand return of
the goods delivered. BIORON Diagnostics shall be authorized to reprocess the returned goods in the required manner. The profits resulting from the reprocessing of the goods must be credited
to the outstanding accounts payable to BIORON Diagnostics by the customer minus the appropriate reprocessing expenses.
VII Duties on receiving of incoming goods
Rights of customer in case of non-conformity
1. The customer is obliged to subject the delivered goods to the customs control on receiving, immediately.
2. Obvious defects, delivery of wrong goods, and variation in quantity must be reported to BIORON Diagnostics by the customer immediately (without undue delay), or must be reported in writing
within seven (7) days, at the latest from the receiving of the goods. Hidden defects must be reported to BIORON Diagnostics in writing within a period of eight (8) days following the discovery
of non-conformity. Notice of hidden defects in quality or quantity shall be excluded and shall be deemed belated after three (3) months beginning with the passing of the risk to the customer
according to Section V No. 1,in the case of the hidden defects were reasonably recognizable. In the case of a belated or not appropriate notice of defect according to Section VII, the customer
shall loose all rights to indemnification, except if the defect was fraudulently concealed by BIORON Diagnostics.
3. In the case of non-conformity of goods supplied by BIORON Diagnostics, BIORON Diagnostics shall only be obliged to rework the goods or deliver goods free from defects (subsequent fulfilment
of contractual obligations). If BIORON Diagnostics is not prepared to carry out reworking or is not in a position to fulfils these measures, due to the fact that the time to get these measures could
be prolonged for reasons for which BIORON Diagnostics is responsible or if the reworking or fulfilment of the obligations should not succeed for other reasons, the customer shall be entitled
to withdraw from the contract or to demand a reduction of the purchase price. A reworking shall be deemed to have failed following the third unsuccessful attempt if no other measures have
been stipulated. If the customer has incurred damage or suffered from futile expenditures resulting from non-conformity of goods delivered by BIORON Diagnostics, the liability of BIORON
Diagnostics in this case is stipulated in Section VII No. 1, Section VIII No. 1 to 6 and Section IX.
VIII Rights and obligations of BIORON Diagnostics
1. A liability on the part of BIORON Diagnostics for damage or futile expenditures – irrespective of the legal basis – shall only arise in the case where the damage or futile expenditures:
● have been caused by BIORON Diagnostics or by one of their authorized personnel or subcontractors by means of culpable violation of a significant contractual obligation or
● are due to a grossly negligent or intentional violation of obligations on the part of BIORON Diagnostics or one of their subcontractors.
1. In compliance with Section VIII No. 1 Letter a) and b) BIORON Diagnostics shall not be liable for damage or futile expenditures, which have been caused by consulting measures or information
provided, were not settled separately, but solely in the case of intentional or grossly negligent breach of obligations, in so far as the breach of duties has not led to material defect according to
§ 434 BGB in the goods delivered by BIORON Diagnostics.
2. If BIORON Diagnostics should be liable for the violation of a fundamental contractual duty in compliance with Section VIII No. 1 letter a), without evidence of gross negligence or intent, the
liability to compensation shall be limited to the foreseeable and typically arising damage. In this case BIORON Diagnostics shall not be held liable for loss of profit to the customer and also not
for unforeseeable consequential damages. The previously mentioned limitations in accordance with regulations 1 and 2 are equally applicable for damages resulting from gross negligence or
intent on the part of BIORON Diagnostics personnel or authorized persons.
3. BIORON Diagnostics shall not be liable for consequential loss of the customer, which arise because of assertion of a claim to contract penalties of a third party.
4. If BIORON Diagnostics shall be liable for the infringement of a fundamental contractual obligation in compliance with Section VIII No. 1 letter a), without evidence of gross negligence or intent,
their liability is limited to the sum of 1,0 Mio Euros per event of damage. BIORON Diagnostics shall be obliged to effect and maintain an insurance to cover claims up to 1.5 million Euros.
5. The liability limitations mentioned in Section VIII No. 1 to 3 shall not apply if BIORON Diagnostics’s liability is in compliance with the regulations contained in the Product Liability Law, or when
claims have been raised due to loss of life, injury to body or health, or when BIORON Diagnostics has guarantied a special property; BIORON Diagnostics shall only be liable for such damage
which is covered by the property.
6. BIORON Diagnostics is not liable to pay an extent compensation other than stipulated in Section VIII No. 1 to 4, irrespective of the nature of valid claims. This especially applies to damage claims
resulting from negligence in the course of conclusion of the agreement in compliance with § 311 Section 3 BGB, violation of contractual duty in compliance with § 280 BGB or due to claims in
tort in compliance with § 823 BGB.
7. In the case the liability for damages is excluded or limited in compliance with Section VIII No. 1 to 5, this shall also apply for all personal liability for damages of the staff, personnel, colleagues,
representatives and subcontractors as well as vicarious agents employed or engaged by BIORON Diagnostics.
IX Limitation of claims
1. Customer claims pertaining to defects in goods delivered by BIORON Diagnostics or relating to unauthorized performance on the part of BIORON Diagnostics – including claims for compensation and claims to replacement of futile expenditure – shall be limited to a period of two (2) years from the beginning of the statutory limitation period, in as far as no other provisions have been
defined in the following Section IX No. 2 and 3.
2. If BIORON Diagnostics has provided incorrect consulting that is not invoiced separately (1) either without delivering goods in connection with incorrect consulting or (2) without incorrect
consulting creating a defect of the goods delivered because of incorrect consulting (§ 434 BGB), the respective claims of the customer shall be subject to a limitation period of one year from
the beginning of the statutory limitation period. Claims raised by the customer against BIORON Diagnostics resulting from the violation of contractual, pre-contractual or statutory obligations
pertaining to substances delivered by BIORON Diagnostics which do not exhibit non-conformity in compliance with § 434 BGB shall also be subject to a limitation period of one year from the
beginning of the statutory limitation period.
In so far as the mentioned breach of obligations is responsible for non-conformity of products delivered by BIORON Diagnostics in compliance with § 434 BGB because of wrong consulting or
advice, claims dealt with shall be subject to the same statutory period of limitation as contained in Number 1 above.
3. The provisions covered by sections 1 and 2 shall not apply to the limitation of claims resulting from loss of life, injuries to body and health as well as the limitation of claims in compliance with
the legislation pertaining to product liability. Furthermore, they shall not apply to the limitation of claims submitted by BIORON Diagnostics’s customers made on the basis that non-conformity
of substances delivered by BIORON Diagnostics has been fraudulently concealed or a contractual obligation has been intentionally violated or in cases of gross negligence. The statutory term
of limitation shall apply to limitation in the case of any of these aforementioned cases.
X Assignment and Transfer of Claims
Contractual obligations of BIORON Diagnostics or claims raised against BIORON Diagnostics, in particular resulting from non-conformity of products delivered by BIORON Diagnostics or from
the breach of contractual obligations on the part of the BIORON Diagnostics cannot be completely or partially transferred or pledged to third parties without the explicit written agreement of
BIORON Diagnostics; § 354 a of the Handelsgesetzbuch (Code of Commercial Law) shall be untouched by these measures.
XI Place of performance
Place of jurisdiction
Applicable law
Trade stipulations
1. The Place of performance and the sole place of jurisdiction for all claims between BIORON Diagnostics and business or legal entities of a statutory company or where statutory fund assets are
involved is Ludwigshafen/Rhein; in so far as there are no mandatory statutory regulations in contradiction to these measures. However, BIORON Diagnostics shall also have the right to initiate
legal proceedings against a customer in the District Court at the place of jurisdiction of the customer.
2. Exclusively the legislation of the Federal Republic of Germany shall apply to the legal relations between BIORON Diagnostics and the customer, as is customary between German businessmen
and which can be effectively agreed upon within the respective supplier countries (see Section I of these terms of sales). The application of regulations pertaining to the Unified international
Purchase Laws (CISG – UN Purchase Law) and the German Private Law is explicitly excluded.
3. In so far as trade stipulations have been agreed in compliance with International Commercial Terms (INCOTERMS), the latest edition of the INCOTERMS shall be valid (currently INCOTERMS
2000).
XII Final provisions
1. Should one of the above mentioned provisions be invalid, partially invalid or excluded by a special agreement, this shall hereby not affect the validity of the remaining provisions.
2. BIORON Diagnostics will store the data of its customers within the scope of their mutual business relations in accordance with the legislation of the Federal Republic of Germany relating to data
protection.
The General Manager of BIORON Diagnostics GmbH
(December 2010)
www.bioron.de
65
IMPRINT
Imprint
BIORON Diagnostics GmbH
Rheinhorststr. 18
67071 Ludwigshafen
Germany
Phone +49 621 5459 0070
Fax
+49 621 5459 0068
[email protected]
www.bioron.de
Legal form: Limited liability company
Managing Director: Dr. Ferdinand Holzinger
Commercial register: AG Ludwigshafen HRB 62298
Registered Office: Ludwigshafen
Value Added Tax Identification Number
(VAT ID) DE 274 094 961
German tax No. 27/656/0100/9
Conditions of Sales/ Export
Please view
the Conditions of Sales at our Website
www.bioron.de.
66
www.bioron.de
67
BIORON Diagnostics GmbH
is a worldwide acting trader of diagnostic
products.
Our customers are distributors, hospitals &
diagnostic labs, research institutes and
biotech companies of all sizes. We have
experience in OEM- & Tender businesses.
We focus on research and innovation in all
sectors where superior technology is required,
such as
Affordable molecular pathogen diagnostic
PCR Thermocycler
● Laboratory equipment
●
●
BIORON products fulfill highest quality &
health standards. Our customers value us for
our individual concern and support.
BIORON Diagnostics GmbH (Germany)
Telefon: 0049 621 545 900 70
Telefax: 0049 621 545 900 68
E-mail:[email protected]
www.bioron.de
`