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The Clearblue PLUS Pregnancy Test is: PLUS Pregnancy Test Easy - one-step urine test, designed to be easiest to use Designed to be the easiest pregnancy test to use Accurate - over 99% accurate from the day the period is due Fast - easy-to-read or result in just 3 minutes Sensitive - can be used up to 4 days before the period is due Trustworthy - the tip changes colour so the user knows urine has been absorbed For more information about the Clearblue PLUS Pregnancy Test, please visit our websites: www.clearblue.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 trade mark Clearblue Professional Series Clearblue Professional Series: ROW-CBPPT v1.0 – June 2011 3 Clearblue PLUS Pregnancy Test As accurate as a doctor’s urine test1 The Clearblue PLUS Pregnancy Test is the next step in visual home pregnancy tests, designed to be the easiest pregnancy test to use, whilst also being as accurate as a doctor’s urine test.1 The innovative Clearblue PLUS Pregnancy Test provides women with six important benefits: 2 • It is over 99% accurate at detecting pregnancy from the day the period is due 3 About Clearblue • It is sensitive enough to be used up to 4 days before the period is due • It has an ergonomically designed handle, designed to make the Clearblue PLUS Pregnancy Test the easiest Clearblue® is the world’s leading brand in home pregnancy and fertility testing. home pregnancy test to use Consumers trust the Clearblue brand because it delivers the accurate information • Its Colour Change Tip helps women to perform the test more easily they want. The Clearblue product range is built on a strong foundation of • Its integrated Flood Guard helps women to use the test correctly peer-reviewed science and consumer understanding. Clearblue products are also • It provides an easy-to-read or result in just 3 minutes. trusted and recommended by doctors, many of whom recognise that Clearblue is supported by 25 years of expertise, quality, and innovation in consumer diagnostics. Over 99% accurate at detecting pregnancy from the day the period is due2 The Clearblue PLUS Pregnancy Test is over 99% accurate at detecting pregnancy from the day the period is due.2 This makes the Clearblue PLUS Pregnancy Test as accurate as a doctor’s urine test.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 luteum4 and has a significant role in the implantation of the blastocyst and protection of the embryo against immune attack at the foetal/maternal boundary. The hormone is initially produced by the embryo and therefore also acts as a marker for its presence.5 Levels of hCG rise rapidly and predictably in the earliest days of pregnancy.6,7 Usually hCG first appears in urine 9-10 days following the estimated day of conception, when using the most sensitive laboratory assays.8 The levels of hCG in early pregnancy have also been found to be highly similar between women.6 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 period is due3 If they are pregnant, most women who test up to 4 days before the day their period is due 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 due. If she still receives a The published literature shows that the level of hCG reaches at least 50 milli-International Units per millilitre not pregnant result, she should test again in 3 days’ time. If this test gives a not-pregnant result and she still (mIU/ml) on the day that a pregnant woman’s period is due.7,9,10 If the Clearblue PLUS Pregnancy Test is used on has not had her period, she should consult a healthcare professional. or after the day the period is due, it is more than 99% accurate.2 Clearblue always recommends that women test from the day their period is due. The high sensitivity of the Clearblue PLUS Pregnancy Test also means that many pregnancies can be detected up to 4 days before the period is due.3 Figure 1 shows a typical rise in urinary hCG from the first detection of However, Clearblue recognises that many women test earlier and so we provide clear information on the pregnancy.7 Day 0 indicates the day the period was due. As the rise in hCG can vary between women, not product pack and instruction leaflet about early testing, including guidance on the proportion of pregnant all women who test before their period is due will get a ‘pregnant’ result. Table 1 shows the likelihood that a women who can expect a pregnant result. This allows women to make an informed choice about whether or pregnant woman will achieve a pregnant result on each test day before her period is due, from a study of 100 not early testing would be the best procedure for them. women using daily urine samples taken during the early stages of pregnancy.3 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 women increase with age and may produce false positive pregnancy tests in non-pregnant 150 peri- or post-menopausal women.11 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 the period is due1, regardless of whether women are 100 pre-, peri- or post-menopausal, so you can be 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 [hCG] (mlU/ml) 50 were pre-, peri- or post-menopausal, the ‘false-positive’ rate of Clearblue PLUS Pregnancy Test was 0.08%.12 0 -6 -5 -4 -3 -2 -1 0 Day relative to expected period Figure 1: Mean levels of hCG on days relative to the day the period was due (n=86 women)7 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: Percentage of samples from pregnant women giving a Number of days before the period was due ‘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.3 6 7 Designed to be the easiest home pregnancy test to use The Colour 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 Colour 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 To perform a Clearblue PLUS Pregnancy Test, the user simply removes the one-piece Test Stick from its test correctly individual foil wrapper, takes off the blue cap and either places the Colour Change Tip in her urine stream for 5 seconds or places the Colour Change Tip into a container of her urine for 5 seconds. The Colour Change Tip • The Clearblue PLUS Pregnancy Test has a large results window which is designed to be easy to read. will instantly turn pink showing that urine is being absorbed. Throughout testing, the Test Stick is held with the Colour 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 her period is due and there is insufficient hCG to generate a ‘pregnant’ result.