Anti-Chlamydia trachomatis IIFT EUROIMMUN IIFT Infectious Serology

Anti-Chlamydia trachomatis IIFT
Positive reaction
Negative reaction
Antibodies against Chlamydia trachomatis
Indications: Test system for the in vitro determination of antibodies against Chlamydia trachomatis in human serum or plasma for the diagnosis of the following diseases: trachoma,
urogenital tract infections and lymphogranuloma venereum.
Clinical significance: The infectious agent Chlamydia trachomatis belongs to the human pathogenic Chlamydia genus, together with Chlamydia pneumoniae and Chlamydia psittaci. It is one
of the smallest intracellular gram-negative bacteria. Around 700 million people are infected
worldwide, with an annual new infection rate of around 50 million. The disease is transmitted
by contact with infected humans.
C. trachomatis is the agent of non-gonorrheal urethritis, lymphogranuloma venereum, trachoma, inclusion conjunctivitis, neonatal pneumonia and Reiter’s syndrome. Sexually transmitted
non-gonorrheal urethritis is the most frequent venereal disease. In Germany the C. trachomatis
serotypes D to K are responsible. They cause urethritis, epididymitis and prostatitis in men, and
urethritis, cervicitis and salpingitis/adnexitis in women. Lymphogranuloma venereum is caused
by the Chlamydia trachomatis serotypes L1 to L3. It is a rare venereal disease which occurs
worldwide but mainly in tropical areas. In tropical regions, C. trachomatis leads to trachoma
(with serotypes A, B, Ba and C), an eye infection of varying severity. It is caused by direct contact with the mucous membranes of the eye, nose and mouth and can be transmitted by common use of hand towels. Around 400 million people suffer from trachoma, which is worldwide
the most frequent cause of blindness (trachoma blindness). In newborns, particularly premature
infants, prenatally or perinatally transmitted C. trachomatis causes pneumonia (serotypes D to
K) in addition to conjunctivitis (ophthalmia neonatorum). This is noticeably often accompanied
by pneumothorax and lifelong health problems.
Despite distinct clinical symptoms, C. trachomatis antibodies are not necessarily produced in
the serum in localised processes. IgM antibodies are not formed in all cases of florid infection.
An increase in IgG titer is also not always found. In problem cases, it is therefore useful to
determine the presence of Chlamydia in infectious secretions using direct immunofluorescence
or to determine their specific genetic sequences using PCR, which is often unsuccessful in cases
where the infection has taken place some time ago. The fastest and most reliable investigation of specific antibodies in infections with C. trachomatis, even with low antibody titers, is
obtained with MIF (microimmunofluorescence) as “gold standard“, IIFT (indirect immunofluorescence test) and ELISA (enzyme linked immunosorbent assay) using MOMP as the target
antigen and taking into consideration different serotypes. Studies throughout Europe show that
these methods are suited to confirming C. trachomatis-induced infertility in women and men by
the determination of C. trachomatis specific serum IgA and IgG antibodies. Recognised medical
centres therefore recommend C. trachomatis screening for both parents before pregnancy.
Fluorescence pattern (positive reaction): Antibodies against Chlamydia trachomatis cause a
fluorescence of the inclusion bodies located in the cytoplasm. These inclusion particles contain
densely organised elementary bodies (infectious form of Chlamydia, diameter 300 nm) and
reticular bodies (non-infectious form of Chlamydia, diameter 1000 nm). Free elementary and
reticular bodies lying between the cells can also react. Some of the cells in the field of view are
not infected and show no fluorescence.
EUROIMMUN IIFT
Infectious Serology
Viruses:
Adenoviruses
Chikungunya virus
Coxsackieviruses
Crimean Congo fever virus (CCHFV)*
Cytomegalovirus (CMV)
Dengue viruses types 1-4 (DENV)
ECHO virus
Epstein-Barr virus capsid antigen (EBV-CA)
Epstein-Barr virus early antigen (EBV.EA)
Epstein-Barr virus nuclear antigen (EBNA)
Hantaviruses (types Hantaan, Puumala, Seou
Saaremaa, Dobrava, Sin Nombre, Andes)*
Herpes simplex virus types 1 and 2 (HSV-1/2)
Human herpes virus type 6 (HHV-6)
HIV-1 and -2*
Influenza virus types A and B
Japanese encephalitis virus (JEV)*
Measles virus
Mumps virus
Parainfluenza viruses types 1-4
Respiratory syncytial virus (RSV)
Rubella virus*
Sandfly fever virus*
(types Sicilian, Naples, Toscana, Cyprus)
SARS Coronavirus (SARS-CoV)
Tick-borne encephalitis (TBE) virus
Varicella zoster virus (VZV)
West Nile virus (WNV)
Yellow fever virus (YFV)
Bacteria:
Afipia felis*
Bartonella henselae
Bartonella quintana
Bordetella parapertussis
Bordetella pertussis
Borrelia afzelii
Borrelia burgdorferi
Borrelia garinii
Campylobacter coli*
Campylobacter jejuni*
Chlamydia pneumoniae
Chlamydia psittaci
Chlamydia trachomatis
Haemophilus influenzae*
Helicobacter pylori
Klebsiella pneumoniae*
Legionella bozemanii*
Legionella dumoffii*
Legionella gormanii*
Legionella jordanis*
Legionella micdadei*
Legionella pneumophila serotypes 1-14
Listeria monocytogenes 1/2 a, 4b*
Mycoplasma hominis
Mycoplasma pneumoniae
Treponema pallidum
Treponema phagedenis
Ureaplasma urealyticum
Yersinia enterocolitica*
Bacteria antigens (EUROPLUS):
Borrelia VlsE (recombinant)
Borrelia OspC
Yeasts:
Candida albicans
Candida glabrata*
Candida krusei*
Candida parapsilosis*
Candida tropicalis*
Parasites:
Echinococcus granulosus
Leishmania donovani
Plasmodium falciparum HRP-2/MSP-2 (rec.)*
Plasmodium vivax MSP/CSP (recombinant)*
Toxoplasma gondii
Profiles:
Accompanying hepatitis profile
Central nervous system profile
Exanthema profile
Fever profile South East Asia
Flavivirus profile
Gastrointestinal tract profile
Infectarthritis profile
Infectarthritis profile (The Tropics)
Lymphadenitis profile
Myocarditis profile
Ophthalmology profile
Otitis profile
Pregnancy profile
Respiratory tract profile
Sexually transmitted diseases (STD) profile
TORCH profile
* Currently not available as IVD in the EU.
Special substrate combinations
on request
Made in Germany
EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Phone +49 451 58550 · Fax 5855591 · E-mail [email protected] · www.euroimmun.de
Test Characteristics
Anti-Chlamydia trachomatis IIFT
EUROIMMUN IIFT
Autoimmune Diagnostics
tissue/cell substrates:
adrenal gland, monkey
bladder, rat
cartilage (trachea), monkey*
cerebellum, monkey
cerebrum, monkey
Crithidia luciliae
erythrocytes, human*
eye, monkey*
granulocytes, human (ethanol-fixed)
granolocytes, human (formaldehyde-fixed)
granulocytes, human (methanol-fixed)
heart, monkey
HEp-2 cells
HEp-20-10 cells
HUVEC
hypothalamus, monkey*
intestine, monkey
kidney, monkey
kidney, mouse
kidney, rat
lacrimal gland, monkey
lip, monkey*
liver, monkey
liver, mouse
liver, rat
lobus temporalis, monkey*
lung, monkey
lymph nodes, monkey*
lymphocytes, human*
mamma, monkey*
mouth mucosa, monkey*
nerve, monkey
oesophagus, monkey
oesophagus, rat
ovary, monkey
pancreas, monkey
parathyroid gland, monkey
parotid gland, monkey
pituitary gland, monkey
placenta, monkey*
prostate, monkey
Saccharomyces cerevisiae
skeletal muscle, monkey
spermatozoa, human
spleen, monkey*
spinal cord, monkey
stomach, monkey
stomach, mouse
stomach, rat
synovium, monkey
testis, monkey
thrombocytes, human
thymus, monkey
thyroid gland, monkey
tongue, monkey
VSM47 cells
umbilical cord, human
EUROPLUS™ substrates:
AIH (LC-1 + SLA/LP)
AMA-M2
gliadin
intrinsic factor
myeloperoxidase (MPO)
PBC (AMA M2 + Sp100)
proteinase 3 (PR3)
ribosomal P-proteins + Jo-1
SS-A + SS-B
SS-B + ribosomal P-proteins + Jo-1
SS-B + Scl-70 + Jo-1
thyroglobulin (TG)
BIOCHIP MosaicsTM:
ANA global test: HEp-20-10/monkey liver
Autoantibody Profile: combination of
30 different tissues per slide
CIBD Profile: monkey pancreas/intest. goblet cells (culture)/
granulocytes (EOH)/Saccharomyces cerevisiae
Basic Profile: HEp-20-10/monkey liver/
rat kidney/rat stomach
EUROPLUS endomysium + gladin:
monkey intestine/monkey liver/gliadin
Granulocyte Mosaic: granulocytes (EOH)/
granulocytes (HCHO)/HEp-2/monkey liver
Liver Mosaic: HEp-2/monkey liver/rat liver
rat kidney/rat stomach/monkey heart
Neuronal Antibody Screen: monkey cerebellum/
monkey nerve/monkey intestine
Polyendocrinopathy Mosaic: monkey thyroid/
monkey pancreas/monkey adrenal/
monkey ovary/monkey testis/monkey stomach
Other mosaics also available
Special substrate combinations
on request
Test principle: The indirect immunofluorescence test is a
standardized in vitro assay for the determination of specific
antibodies against C. trachomatis. BIOCHIPs are coated with
C. trachomatis infected cells and fixed onto the reaction
fields of a microscope slide. With EUROIMMUN BIOCHIP
Mosaics®, different substrates can be positioned next to each
other in one reaction field and incubated with one drop of
diluted serum, allowing a detailed patient antibody profile to
be established with a single test.
Test procedure: EUROIMMUN BIOCHIP slides are incubated
using the proprietary TITERPLANE™ Technique, which enables multiple samples to be incubated next to each other
and simultaneously under identical conditions. Results are
evaluated by fluorescence microscopy. Incubation of the
substrate with the positive and negative control sera provided in each kit verifies correct performance of the test and
aids evaluation.
Incubation with the
TITERPLANE™ Technique
Reagent
tray
Slide
fitted with
BIOCHIPs
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Inter-lot reproducibility: Inter-lot reproducibility was tested with more than 10 different lots.
The deviation in the fluorescence intensity of the IIFT amounted to to no more than ± 1 intensity
level for all samples.
Reference range: titer 1: < 10 (IgM), titer 1: < 100 (IgA), titer 1: < 320 (IgG)
The following antibody prevalences were determined for healthy blood donors (origin of
samples: Germany): IgG: 22% (n = 100); IgA: 1% (n = 200); IgM: 3% (n = 200).
Specificity and sensitivity:
Substrate
Reference (number and origin of samples)
Specificity
C. trachomatis
(IgG)
Clinical specificity (healthy blood donors, n = 100, Germany)
Direct detection (n = 100, Germany)
78%
C. trachomatis
(IgA)
Anti-Chlamydia trachomatis ELISA (n = 106, Germany)
Anti-Chlamydia trachomatis ELISA (n = 32, Germany)
86%
C. trachomatis
(IgM)
Clinical specificity (healthy blood donors, n = 200, Germany)
Direct detection (n = 32, Germany)
98%
Sensitivity
79%
85%
63%
Technical Data:
Antigen substrate
Chlamydia trachomatis infected cells (species EU 70).
Sample dilution
Serum or plasma.
Qualitative evaluation: 1:10 (IgM), 1:100 (IgA), 1:320 (IgG)
Quantitative evaluation: from 1:10 (IgM), 1:100 (IgA), 1:320 (IgG)
Test procedure
30 min (sample) / 30 min (conjugate), room temperature.
Microscopy
Objective 20x
Excitation filter: 488 nm, colour separator: 510 nm, blocking filter: 520 nm
Light source: EUROIMMUN LED or mercury vapour lamp, 100 W
Reagents
Ready for use, with the exception of the PBS-Tween buffer (for dilution
and washing).
Stability
All kit components are stable for up to 18 months from the date of
manufacture.
Standard kit formats
10 or 20 slides, each containing 3, 5 or 10 test fields.
Kits include all necessary reagents (except EUROSORB for the RF
absorption, order no.: ZF1270-0145).
Order no.
FI 2191-1005 A, G or M
(test kits with 10 slides, each with 5 test fields)
Related products
FI 2191-1005-3 G (Anti-Chlamydia MIF)
* Currently not available as IVD in the EU.
Made in Germany
Version: 08/08
FI_2191_D_UK_B01
EUROIMMUN AG · D-23560 Luebeck (Germany) · Seekamp 31 · Phone +49 451 58550 · Fax 5855591 · E-mail euroimmun[email protected] · www.euroimmun.de
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