Clearblue Digital Pregnancy Test with Conception Indicator is the latest innovation in pregnancy testing. This simple to use product is unique in that not only does it inform a woman whether she is pregnant or not, but also indicates when she conceived. The test is >99% accurate in detecting pregnancy and 92% accurate in estimating time since conception.

Since the Clearblue Digital Pregnancy Test with Conception Indicator is classified as a medical device, it does not require marketing authorisation from the EMEA. Under the In Vitro Diagnostic Medical Devices Directive, the Clearblue Digital Pregnancy Test with Conception Indicator has received a CE marking which entitles it to be sold throughout Europe.

Like other pregnancy tests FDA clearance will be required prior to marketing the Clearblue Digital Pregnancy Test with Conception Indicator in the US. This pregnancy test is not currently available in the US.

The Clearblue Digital Pregnancy Test with Conception Indicator was launched in July 2008 in the UK and in Ireland and launches in other European countries will take place during 2008.

Clearblue has been working closely with consumers and healthcare professionals for over 20 years to deliver trusted, quality products in pregnancy and fertility.

The Clearblue Digital Pregnancy Test with Conception Indicator can be used very simply either by holding the absorbent sampler in the urine stream for 5 seconds or by dipping the absorbent sampler into urine collected in a clean container, for 20 seconds.

Since the Clearblue Digital Pregnancy Test with Conception Indicator is a digital test the result is provided in words and numbers so that there is no line interpretation or ambiguity.

In a study conducted by Clearblue, 114 consumers were asked to complete a questionnaire on their experiences with the Clearblue Digital Pregnancy Test with Conception Indicator. They were asked to indicate whether they found the instructions for the Clearblue Digital Pregnancy Test with Conception Indicator "very easy", "easy" or "not easy" to understand. Over 99% of women found the instructions"very easy" or "easy" to understand. In the same study, 93.8% of women found the Clearblue Digital Pregnancy Test with Conception Indicator "very easy" or "easy" to use.

The Clearblue Digital Pregnancy Test with Conception Indicator is unique and different to other pregnancy tests because it combines a Conception Indicator feature with a pregnancy test.

If the result is ‘Pregnant’ the Conception Indicator provides an estimate of the number of weeks since conception.

We found from research with over 3000 consumers that this was information women wanted once they knew they were pregnant. Discovering when conception took place may assist a woman in planning for the pregnancy. For example a woman may want to modify her lifestyle or seek pre-natal care early on in pregnancy.

The Clearblue Digital Pregnancy Test with Conception Indicator is not a replacement to the healthcare that women receive and therefore this should be maintained. For example, scans and tests normally provided in the first trimester of pregnancy should be continued.

The Clearblue Digital Pregnancy Test with Conception Indicator can be used up to 4 days before a period is due. If the test is used before a period is due and a ‘Not Pregnant’ result is obtained, there is still a chance that a woman may be pregnant but that the level of hCG is still not high enough for the test to detect, and the woman should re-test on the date she expected her period.

The Clearblue Digital Pregnancy Test with Conception Indicator is suitable for most women to use but women taking medication or older women may need to be advised to use caution in interpreting results. Unexpected results may be obtained if a woman has received hCG as fertility treatment, if her periods are irregular, if she has recently been pregnant, or has ovarian cysts, an ectopic or abnormal pregnancy, or is perimenopausal or menopausal. Multiple and ectopic pregnancies can give misleading Conception Indicator results.

This information is explained in the instruction leaflet which can be found inside the Clearblue Digital Pregnancy Test with Conception Indicator. Women can also find further information on the Clearblue website – www.Clearblue.info

The Clearblue Digital Pregnancy Test with Conception Indicator is available in retail chemists, online pharmacies and the Clearblue online shop at www.clearblueonlineshop.inon.com

In the UK, the test will be priced at £9.99 for one test and £13.99 for two tests. This is the same price as the Clearblue Digital Pregnancy Test so essentially consumers are getting the Conception Indicator feature at no extra cost.

As with other home pregnancy tests, the Clearblue Digital Pregnancy Test with Conception Indicator detects human Chorionic Gonadotropin (hCG), a hormone which is present in urine and blood very early on in pregnancy¹.

The Conception Indicator feature is designed to estimate the time since conception occurred. This estimate assumes that conception occurred on the day of ovulation, which is defined as the day after the urinary luteinising hormone (LH) surge. The Conception Indicator feature 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 or more weeks since conception. These thresholds are based on extensive research of urinary hCG rise in early pregnancy determined using the LH surge as a marker for the day of conception. Clinical studies have shown that conception is most likely to occur on the day of LH surge or the day after (LH+1)³.

Using the latest advances in micro-semiquantitation the test measures hCG at three thresholds on two test strips to determine the amount of hormone in the sample and thus calculate time since conception.

In laboratory tests the Clearblue Digital Pregnancy Test with Conception Indicator is more than 99%² accurate in detecting pregnancy, when used from the day the period is due.

The Conception Indicator feature is 92%² accurate in estimating the time since conception, when using first urine of the day. This is based on levels of hCG in the urine.

Numerous clinical and consumer studies have been conducted to establish the accuracy of the Clearblue Digital Pregnancy Test with Conception Indicator.

In a study involving 400 women who were attempting to conceive, the Clearblue Digital Pregnancy Test with Conception Indicator demonstrated over 99% accuracy in detecting pregnancy when compared to an extremely sensitive automated laboratory method².

To validate the Conception Indicator feature in estimating the time since conception a study was conducted amongst women who had conceived. Over 2500 first morning urine samples were collected each day during the first cycle in which the women became pregnant. Each sample was tested using the Clearblue Digital Pregnancy Test with Conception Indicator. Results of the Conception Indicator feature were compared to estimated time since conception based on detection of LH in the urine and taking LH+1 as the day of conception. The overall accuracy of the Clearblue Conception Indicator was 92%².

On an individual basis on any given day, the actual levels of hCG detectable in women are different but nevertheless fall within a well-defined and statistically limited range⁴. Studies have shown that levels of hCG in serum and urine rise rapidly and predictably during the first days of pregnancy⁴ and that absolute levels of hCG in urine are highly similar between women on each day following first detection of hCG². Moreover, in clinical studies, absolute levels of hCG have been used to define gestational ageing^5,6.

The Conception Indicator feature gives an estimate of time since conception that ranges in weeks (1-2, 2-3 and over 3 weeks). In order to calculate this, hCG levels from approximately 3000 pregnant samples were analysed. The data generated enabled Clearblue to establish the likely hCG concentration in each of these time bands and from this the thresholds on which the test works were set.

The overall accuracy of the Clearblue Conception Indicator has been clinically proven to be 92%. The accuracy of the Clearblue Conception Indicator is 96.5% in the 1-2 week range, 76.1% in the 2-3 week range and 96.9% in the 3+ weeks range.

The Clearblue Conception Indicator gives only an estimate of time since conception because individual hCG levels vary from woman to woman, within a well-defined range, on a day-to-day basis^4,7. It would therefore be difficult to define thresholds for the test which calculate the exact time of conception.

In the trial on approximately 3000 individual pregnant samples there was a consistent pattern to urinary hCG levels only up to the first three weeks following conception². After that, levels varied too widely from woman to woman to be able to provide an accurate estimate of time since conception.

Several recent studies have indicated that the menstrual cycle length varies widely from woman to woman, and from month to month in any given woman ^2,4,7. Studies have shown that it is the length of the follicular phase of a menstrual cycle that is the cause of menstrual length variability^2,7. Therefore using the LMP to determine time of ovulation and conception is unreliable. Studies have shown that urinary hCG levels relative to the day of the LH surge to estimate time since conception is a more accurate method².