The Clearblue PLUS Pregnancy Test is: Easy - one-step urine test, designed to be easiest to use Accurate - over 99% accurate from the day of the expected period Fast - easy-to-read or PLUS Pregnancy Test Designed to be the easiest pregnancy test to use result in just 3 minutes Sensitive - can be used up to 4 days before the expected period (5 days sooner than the day of the missed period) Trustworthy - the tip changes color so the user knows urine has been absorbed For more information about the Clearblue PLUS Pregnancy Test, please visit our websites: www.clearblueeasy.com www.swissprecisiondiagnostics.com SPD Swiss Precision Diagnostics GmbH, 1213 Petit Lancy, Geneva, Switzerland ©2011 SPD Swiss Precision Diagnostics GmbH. All rights reserved. Clearblue is a trademark Clearblue Professional Series: US-CBPPT v1.0 – June 2011 Clearblue Professional Series 3 Clearblue PLUS Pregnancy Test Designed to be easiest to use The Clearblue PLUS Pregnancy Test is the next step in visual home pregnancy tests, designed to be the easiest pregnancy test to use. The innovative Clearblue PLUS Pregnancy Test provides women with six important benefits: About Clearblue • It is over 99% accurate at detecting pregnancy from the day of the expected period1 •It is sensitive enough to be used up to 4 days before the expected period (5 days sooner than the day of the missed Clearblue® is the world’s leading brand in home pregnancy and fertility testing. Consumers trust the Clearblue brand because it delivers the accurate information they want. The Clearblue product range is built on a strong foundation of peer-reviewed science and period)2 •It has an ergonomically designed handle, designed to make the Clearblue PLUS Pregnancy Test the easiest home pregnancy test to use consumer understanding. Clearblue products are also trusted and recommended by • Its Color Change Tip helps women to perform the test more easily doctors, many of whom recognize that Clearblue is supported by 25 years of expertise, • Its integrated Flood Guard helps women to use the test correctly quality, and innovation in consumer diagnostics. • It provides an easy-to-read or result in just 3 minutes. Over 99% accurate at detecting pregnancy from the day of the expected period1 The Clearblue PLUS Pregnancy Test is over 99% accurate at detecting pregnancy from the day of the expected period.1 The Clearblue PLUS Pregnancy Test detects the presence of urinary levels of human chorionic gonadotropin (hCG), a clinically accurate marker of pregnancy. The production of hCG occurs in the earliest stages of pregnancy, where it plays a role in the survival of the corpus luteum3 and has a significant role in the implantation of the blastocyst and protection of the embryo against immune attack at the fetal/maternal boundary. The hormone is initially produced by the embryo and therefore also acts as a marker for its presence.4 Levels of hCG rise rapidly and predictably in the earliest days of pregnancy.5,6 Usually hCG first appears in urine 9-10 days following the estimated day of conception, when using the most sensitive laboratory assays.7 The levels of hCG in early pregnancy have also been found to be highly similar between women.5 This makes hCG an ideal urinary marker for quickly and accurately assessing whether a woman is pregnant or not. 4 5 Can be used up to 4 days before the expected period2 The published literature shows that the level of hCG reaches at least 50 milli-International Units per millilitre (mIU/ml) on the day of the expected period.6,8,9 If the Clearblue PLUS Pregnancy Test is used on or after the day of the expected period, it is more than 99% accurate.1 The high sensitivity of the Clearblue PLUS Pregnancy Test also means that many pregnancies can be detected up to 4 days before the expected period (5 days sooner than the day of the missed period).2 Figure 1 shows a typical rise in urinary hCG from the first detection of pregnancy.6 Day 0 indicates the day of the expected period. As the rise in hCG can vary between women, not all women who test before their period is expected will get a ‘pregnant’ result. Table 1 shows the likelihood that a pregnant woman will achieve a pregnant result on each test day before her period is expected, from a study of 100 women using daily urine samples taken during the early stages of pregnancy.2 If they are pregnant, most women who test up to 4 days before the day of their expected period will have sufficient urinary hCG to provide a positive result. However, this cannot be guaranteed, so if a woman receives a not-pregnant result when testing early, she should test again on the day her period is expected. If she still receives a not-pregnant result, she should test again in 3 days’ time. If this test gives a not-pregnant result and she still has not had her period, she should consult a healthcare professional. Clearblue always recommends that women test from the day of their expected period. However, Clearblue recognizes that many women test earlier and so we provide clear information on the product pack and instruction leaflet about early testing, including guidance on the proportion of pregnant women who can expect a pregnant result. This allows women to make an informed choice about whether or not early testing would be the best procedure for them. Urinary concentration of hCG in early pregnancy Over 99% accuracy for all women, regardless of age 200 Importantly, the Clearblue PLUS Pregnancy Test’s innovative technology means that, although it is highly sensitive, the proportion of ‘false-positive’ results associated with the device is extremely low. Concentrations of hCG in non-pregnant [hCG] (mlU/ml) women increase with age and may produce false positive pregnancy tests in non-pregnant peri- or post-menopausal 150 women.10 With one currently marketed home pregnancy test, the manufacturer’s data suggests that as many as 4% of women aged 41-55 years obtained false ‘pregnant’ results. The Clearblue PLUS Pregnancy Test is over 99% accurate from the day of the expected period1, regardless of whether women are pre-, peri- or post-menopausal, so you can be 100 confident that a woman who has received a ‘pregnant’ result with the Clearblue PLUS Pregnancy Test really is pregnant. In a study of 300 urine samples from women who were pre-, peri- or post-menopausal, the ‘false-positive’ rate of Clearblue PLUS Pregnancy Test was 0.08%.11 50 0 -6 -5 -3 -2 -4 Day relative to expected period -1 0 Figure 1: Mean levels of hCG on days relative to the day the period was expected (n=86 women)6 The amount of pregnancy hormone increases rapidly in early pregnancy. In clinical testing with early pregnancy samples, the Clearblue PLUS Pregnancy Test gave the following results: Number of days before the expected period Percentage of samples from pregnant women giving a ‘pregnant’ result -1 98% -2 97% -3 88% -4 56% Table 1: Likelihood that a pregnant woman will achieve a pregnant result with the Clearblue PLUS Pregnancy Test on each early test day.2 6 7 Designed to be the easiest home pregnancy test to use The Color Change Tip helps women perform the test correctly The Clearblue PLUS Pregnancy Test contains a number of innovative features that have been designed to make it the easiest home pregnancy test to use: •It has a long handle with an ergonomically designed stick and grip to help the user hold the device correctly in her urine stream •The Clearblue PLUS Pregnancy Test has a wide 18 mm sampler to help the user obtain an adequate sample from their urine stream •The Clearblue PLUS Pregnancy Test has a Color Change Tip which lets the user know that urine has been absorbed •The Clearblue PLUS Pregnancy Test provides clear and test result line combinations providing an easy-to-read result. Furthermore, the device is made from white laminate reflective material which provides a clear visual contrast against the blue lines in the Test and Control windows •The Clearblue PLUS Pregnancy Test has an integrated Flood Guard feature which helps women to use the test correctly •The Clearblue PLUS Pregnancy Test has a large results window which is designed to be easy to read. To perform a Clearblue PLUS Pregnancy Test, the user simply removes the one-piece Test Stick from its individual foil wrapper, takes off the blue cap and either places the Color Change Tip in her urine stream for 5 seconds or places the Color Change Tip into a container of her urine for 5 seconds. The Color Change Tip will instantly turn pink showing that urine is being absorbed. Throughout testing, the Test Stick is held with the Color Change Tip pointing downwards, or is laid flat until the user is ready to read the results. Provides an easy-to-read or result in just 3 minutes As the test begins to work, blue lines will start to develop in the device windows. After 3 minutes, a blue line should have appeared in the smaller Control Window and the result can be read in the larger Test Window. •A result in the Test Window means that the user is pregnant. It does not matter if one of the lines that make up the symbol is lighter or darker than the other; the result is still ‘pregnant’. •A result in the Test Window means that the user is not pregnant, unless she is testing before the day of her expected period and there is insufficient hCG to generate a ‘pregnant’ result. The Test Window must be read between 3 and 10 minutes after completing the test. If no blue line has appeared in the Control Window after 10 minutes, the test has not worked. 8 9 Helps women to use the test correctly About SPD Swiss Precision Diagnostics GmbH Occasionally excess urine can enter a home pregnancy test. This usually happens because the woman holds the stick incorrectly in her urine stream, or urinates for too long on the test stick wick. This can occasionally cause the test to run incorrectly. No control line is present as the test has not worked. The Clearblue PLUS Pregnancy Test has an integrated ‘Flood Guard’, which collects excess urine and helps women to use the test correctly. Even though this is a problem for only a small number of women, Clearblue aims for all women to have the best products to help them test correctly, and obtain the accurate information that they want. SPD Swiss Precision Diagnostics GmbH is a world leader in the research, design, production, and supply of advanced consumer diagnostic products. Our brands, such as Clearblue®, Fact Plus®, and Accu-Clear®, are familiar in many countries, and are trusted for their accuracy and simplicity by women keen to know more about their own reproductive health. SPD brands are acclaimed for their pioneering innovation: Clearblue was the first brand to introduce a one-step pregnancy test, a one-minute test, a urine sample indicator, and digitally displayed results. At SPD, we are committed to helping people make informed decisions about their health and well-being, through a continuing flow of new and inventive developments. Our research center is at the sharp edge of innovation, and is fully Additional points engaged in the development of reliable diagnostic products for better health and personal self-care. •When testing on or after the day of the expected period, it is not necessary to test with an early morning urine sample. When testing before the day of the expected period, an early morning urine sample should always be used. Regardless of when the test is performed, excessive fluid intake should be avoided before testing as a false not-pregnant result If you are a healthcare professional and wish to contact a member of the Clearblue support team about any product in the Clearblue range, please send an email to [email protected] may be obtained if the urine sample is too dilute. •The manufacturer’s instructions regarding any medication being taken should be read before conducting the test. •Fertility drugs containing hCG can affect the result. These are usually given by injection, and testing too soon (within 14 days) after administration of the drug can give a false not-pregnant result. However, other symptoms are likely to be experienced, and if an ectopic pregnancy is suspected then immediate medical advice must be sought. •Ovarian cysts, menopause and some very rare medical conditions, notably gestational trophoblastic diseases such as hydatidiform mole, choriocarcinoma and cervical intraepithelial neoplasia can give misleading results.12 •A recent pregnancy, miscarriage or termination can give misleading results. It is possible for hCG to be found in the body for up to 3 weeks after giving birth13 and for up to 9 weeks after a miscarriage or termination14. Whilst hCG remains in the body it is possible for a pregnancy test to detect it and show a false •If a SPD Swiss Precision Diagnostics GmbH 47 Route de Saint-Georges 1213 Petit Lancy pregnant result. •Ectopic pregnancy can result in the production of lower levels of hCG than in a normal pregnancy, which may lead to a false Alternatively, you could write to us at: pregnant result. pregnant result is obtained and the woman later finds out that she is not pregnant, then it is possible that this is due to natural loss of the pregnancy, which can occur in the early stages. It is estimated that only 30% of pregnancies result in live birth, though most losses are preclinical, with approximately 30% being considered an early pregnancy loss and 30% implantation failure.16,17 The remaining 10% of pregnancies are clinical miscarriage.16,17 Both early pregnancy losses and clinical miscarriages are likely to have hCG present in urine at the time of the expected period. • Women should be encouraged to discuss any unexpected results with a healthcare professional. Geneva Switzerland www.swissprecisiondiagnostics.com 10 11 References 1. Data on file. When compared to a laboratory reference method, Clearblue PLUS Pregnancy Test has been shown to be over 99% accurate from the day of the expected period when using urine samples supplied for pregnancy testing. Reference method used: Perkin Elmer Delfia hCG. 2.Data on file. Clearblue recommends that women test from the day of the expected period. However, the pregnancy hormone increases rapidly in early pregnancy and Clearblue PLUS Pregnancy Test can be used to test up to 4 days before the expected period, which is 5 days sooner than waiting for the missed period. In clinical testing, Clearblue PLUS Pregnancy Test detected the pregnancy hormone in 56% of women when testing 4 days before their expected period, 88% at 3 days before their expected period, 97% at 2 days before their expected period, and 98% at 1 day before their expected period. 3.Baird DD, Weinberg CR, McConnaughey DR, Wilcox AJ. Rescue of the corpus luteum in human pregnancy. Biol Reprod 2003;68(2):448-56. 4.Perrier d’Hauterive S, Berndt S, Tsampalas M, Charlet-Renard C, Dubois M, Bourgain C, et al. Dialogue between blastocyst hCG and endometrial LH/ hCG receptor: which role in implantation? Gynecol Obstet Invest 2007;64(3):156-60. 5.Nepomnaschy PA, Weinberg CR, Wilcox AJ, Baird DD. Urinary hCG patterns during the week following implantation. Hum Reprod 2008;23(2):271-7. 6.Johnson SR, Miro F, Barrett S, Ellis JE. Levels of urinary human chorionic gonadotrophin (hCG) following conception and variability of menstrual cycle length in a cohort of women attempting to conceive. Curr Med Res Opin 2009;25(3):741-8. 7.Wilcox AJ, Baird DD, Weinberg CR. Time of implantation of the conceptus and loss of pregnancy. N Engl J Med 1999;340(23):1796-9. 8.Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human chorionic gonadotropin from the time of implantation until the second week of pregnancy. Fertil Steril 1982;37(6):773-8. 9. Chard T. Pregnancy tests: a review. Hum Reprod 1992;7(5):701-10. 10.Snyder JA, Haymond S, Parvin CA, Gronowski AM, Grenache DG. Diagnostic considerations in the management of hCG in aging women. Clin Chem 2005 Oct;51(10):1830-5. 11.Data on file. Study of 300 pre-, peri- and post-menopausal urine samples comparing the result from the Clearblue PLUS Pregnancy Test with quantitative hCG levels measured using AutoDelfia (Perkin Elmer). 12.Stenman UH, Tiitinen A, Alfthan H, Valmu L. The classification, functions and clinical use of different isoforms of HCG. Hum Reprod Update 2006 NovDec;12(6):769-84. 13.Korhonen J, Alfthan H, Ylöstalo P, Veldhuis J, Stenman UH. Disappearance of human chorionic gonadotropin and its alpha- and beta-subunits after term pregnancy. Clin Chem 1997 Nov;43(11):2155-63. 14.Steier JA, Bergsjø P, Myking OL. Human chorionic gonadotropin in maternal plasma after induced abortion, spontaneous abortion, and removed ectopic pregnancy. Obstet Gynecol 1984 Sep;64(3):391-4. 15.Chard T. Frequency of implantation and early pregnancy loss in natural cycles. Baillieres Clin Obstet Gynaecol 1991 Mar;5(1):179-89. 16.Macklon NS, Geraedts JP, Fauser BC. Conception to ongoing pregnancy: the ‘black box’ of early pregnancy loss. Hum Reprod Update 2002 JulAug;8(4):333-43.
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