The Test that Revolutionizes Home Pregnancy Testing
The Clearblue Advanced Pregnancy Test with Weeks Estimator is the latest innovation in pregnancy testing. It is the first and only pregnancy test that also provides an estimate of time since ovulation, for women testing pregnant.
- It is an over-the-counter semi-quantitative urine test for human chorionic gonadotropin (hCG), which is intended for the detection of pregnancy.
- It is over 99% accurate at determining pregnancy, when testing from the day of the expected period.1
- Uniquely it not only informs a woman whether she is pregnant or not, but, if she is pregnant, it also estimates the time since ovulation, in categories of 1-2, 2-3 and 3+ weeks.
Indications for use: The Clearblue Advanced Pregnancy Test with Weeks Estimator is an over-the-counter urine hCG test which is intended for the detection of pregnancy. The test detects hCG in some cases from 4 days before the expected period (which is 5 days before the day of the missed period).
This test is only intended for individual use at home. It is not intended for use in a healthcare setting.
This test contains a 'Weeks Estimator.' The 'Weeks Estimator' is meant solely as an estimate for the consumer and is not intended as a substitute for a doctor's clinical diagnosis. The ’Weeks Estimator’ is not intended for multiple pregnancies. The estimate provided by the device may be inaccurate in these cases.
This test cannot be used to determine the duration of pregnancy or to monitor the progression of pregnancy. Your doctor determines how many weeks pregnant you are based on the first day of your last menstrual period and ultrasound results. This test provides a different estimate that cannot be substituted for a doctor’s determination of gestational age. Only your doctor can provide a reliable estimate of gestational age and only your doctor can monitor pregnancy progression. You should seek qualified prenatal care if you suspect you are pregnant.
Accurate and sensitive for the detection of pregnancy
The Clearblue Advanced Pregnancy Test with Weeks Estimator is also sensitive enough to be used up to 4 days before the expected period (Table One).2
|Table One. Percentage of pregnancies detected with the Clearblue Advanced Pregnancy Test with Weeks Estimator.1,2|
|Days before expected period||4||3||2||1||0|
|Pregnancy detection rate, %||65.5||90.6||97.9||98.8||99.0|
Unique “Weeks Estimator” feature
- As with other home pregnancy tests, the Clearblue Advanced Pregnancy Test with Weeks Estimator detects hCG, the hormone produced early in pregnancy and excreted in the urine.3
- Uniquely, in addition to detecting hCG, the Clearblue Advanced Pregnancy Test with Weeks Estimator also measures the level of hCG to estimate time since ovulation.
- The Weeks Estimator feature assumes ovulation occurred on the day after the urinary luteinizing hormone (LH) surge4,5 and works on a threshold basis of urinary hCG levels: there are three time bands that give an estimate of 1-2, 2-3 and 3+ weeks since ovulation (Figure One). These thresholds are based on extensive research of urinary hCG rise in early pregnancy.6
Gives the earliest estimation of time since ovulation
Traditionally the day of the last menstrual period (LMP) has been used to date early pregnancy, as in most cases this is the only information available at this stage. However, many women have poor recollection of their LMP7 and it provides an estimate accurate to within a week in only 46% of women.8
The day of fertilization is the most accurate method for dating pregnancy and this can be estimated from the day of ovulation, as studies have shown that the egg survives for only 16-17 hours9 and that a woman’s fertile period ends on the day of ovulation.10–12
The Clearblue Advanced Pregnancy Test with Weeks Estimator is more accurate than LMP.
- It gives an estimate of time since ovulation relative to the LH surge.13
- Agreement of the Weeks Estimator results with other clinical findings ranges widely from 45-99%.14
How the Clearblue Advanced Pregnancy Test with Weeks Estimator results relate to clinical care
The package insert makes it clear that women should seek guidance from a healthcare professional (HCP) on receipt of a positive (Pregnant) result, and also helps to put the results into context with other methods of pregnancy dating; i.e., this test estimates time since ovulation, which can be related to the way a doctor dates pregnancy if an idealized follicular phase (14 days) is added to the Weeks Estimator result. The table below is included in the package insert of the product to enable women to understand how the result from their Clearblue Advanced Pregnancy Test with Weeks Estimator relates to pregnancy dating by HCPs (Table Two). The Clearblue Advanced Pregnancy Test with Weeks Estimator is not a replacement for clinical care, but rather provides information that a woman is immediately interested in once she has received a pregnant result, i.e., “how long is it since I ovulated?”
|What does this mean?||Your result is Pregnant and you may be 1-2 weeks since ovulation.||Your result is Pregnant and you may be 2 and up to 3 weeks since ovulation.||Your result is Pregnant and you may be more than 3 weeks since ovulation.|
|How your doctor may date your pregnancy (weeks pregnant)*
||3-4 weeks||4-5 weeks||5+ weeks|
The Clearblue Advanced Pregnancy Test with Weeks Estimator is:
- Accurate - over 99% accurate in detecting pregnancy from the day of the expected period1
- Unique - the FIRST and ONLY pregnancy test that can estimate time since ovulation, for women testing pregnant
- Clinically proven - high level agreement with time since ovulation determined by LH surge13
- Sensitive - can be used up to 4 days before the expected period (5 days sooner than the day of the missed period)2
- Unmistakably clear - results displayed in words and numbers on a digital screen
- Reliable - based on established technology
- Simple to Use - convenient and easy to interpret
- Trustworthy- from Clearblue, the world’s #1 selling brand* in home pregnancy and fertility tests
Always read full instruction leaflet of product before use. This material is intended for healthcare professionals only. It is for general information only with no warranties, representations or undertakings, express or implied, and does not constitute medical advice. It may refer to products not yet registered or approved in a given country. Please ask your local pharmacist or SPD contact for products available in your country. Product images are for illustration only. Clearblue is a trademark of SPD Swiss Precision Diagnostics GmbH (“SPD”). ©2013 SPD (except for any third party content identified as such). All rights reserved.
*Based on international sales in nearly 20 countries compiled using independent market research
1 Data on file: Overall agreement of 99.4% when the Clearblue Advanced Pregnancy Test with Weeks Estimator was compared with quantitative detection of hCG concentration in 300 urine samples, using 3 different batches of device.
2 Data on file: Using urine samples from 135 pregnant women the Clearblue Advanced Pregnancy Test with Weeks Estimator detected 65.5% of pregnancies 4 days before the day of the expected period, 90.6%, 97.9% and 98.8% for 3, 2 and 1 days before, respectively.
3 Vaitukaitis JL. Development of the home pregnancy test. Ann N Y Acad Sci. (2004) 1038: 220–222.
4 Burger HG. Estradiol: the physiological basis of the fertile period. Int J Gynecol Obstet. (1989) Suppl 1: 5–9.
5 Collins WP. Hormonal indices of ovulation and the fertile period. Adv Contracept. (1985) 1: 279–294.
6 Johnson SR, et al. 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: 741–748.
7 Geirsson RT, Busby-Earle RM. Certain dates may not provide a reliable estimate of gestational age. Br J Obstet Gynaecol. (1991) 98: 108–109.
8 Mustafa G, David RJ. Comparative accuracy of clinical estimate versus menstrual gestational age in computerized birth certificates. Public Health Reports. (2001) 116: 15–21.
9 Ferreira-Poblete A. The probability of conception on different days of the cycle with respect to ovulation: an overview. Adv Contracept. (1997) 13: 83–95.
10 Wilcox AJ, et al. Timing of sexual intercourse in relation to ovulation. Effects on the probability of conception, survival of the pregnancy, and sex of the baby. N Engl J Med. (1995) 333: 1517–1521.
11 Dunson DB, et al. Day-specific probabilities of clinical pregnancy based on two studies with imperfect measures of ovulation. Hum Reprod. (1999) 14: 1835–1839.
12 Keulers MJ, et al. The length of the fertile window is associated with the chance of spontaneously conceiving an ongoing pregnancy in subfertile couples. Hum Reprod. (2007) 22: 1652–1656.
13 Johnson S, Perry P, Alonzo T, Zinaman M. Analytical Performance of Home Pregnancy test that estimates time since ovulation based on hCG threshold concentration at week boundaries. Clin Chem (2013) S209;B45
14 Johnson S, et al. Accuracy of a home-based device for giving an early estimate of pregnancy duration compared with reference methods. Fertility and Sterility. (2013) 100: 1635–1641.