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This booklet introduces the new Clearblue Digital Pregnancy Test. It highlights the key features and benefits of the product, gives background facts about pregnancy testing, and explains how the product works. Also contained within this booklet is information about Unipath and its other products.

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Introduction to Clearblue Digital Pregnancy Test

Background Facts about Pregnancy Testing

How the Test Works

Additional Information

Unipath’s Product Range

introducingClearblue pregnancy test

the easiest test ever

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• Fully integrated, easy, one-step test

• Unmistakably clear results in words – ‘Pregnant’ or ‘Not Pregnant’ shown on the Display

• Over 99% accuracy from the day the period is due for confidence in the result

• Reassurance throughout the testing process with clear symbols on the digital display to show

test progression and error messages

• Sensitive enough (2�mIU/ml) to offer women the choice of testing up to 4 days before their

period is due

Clearblue – committed to certainty

Easy to use with unmistakably clear results – Clearblue Digital Pregnancy Test is the easiest test ever.

The first ever one-step digital pregnancy test which gives a result in words, Clearblue Digital Pregnancy Test is a fully integrated pregnancy test. As a result of extensive consumer insight and years of industry experience, Clearblue Digital Pregnancy Test has been developed to offer women a test they can perform with ease and a result they can have confidence in. The new test also now offers women the choice of testing up to 4 days before their period is due.

Clearblue Digital Pregnancy Test is easy to use. The user simply removes the one-piece Test Stick from its individual foil wrapper, removes the cap and places the Absorbent Sampler in her urine stream for � seconds. Alternatively she can place the Sampler into a container of her urine for 20 seconds. Within � minutes the liquid crystal display (LCD) on the Test Stick will show a ‘Pregnant’ or ‘Not Pregnant’ result.

The Clearblue Digital Pregnancy Test has been designed to ensure women feel confident in their result. Whilst the test is running, a flashing ‘wait’ symbol will be shown on the Display. When the symbol stops flashing, the result will appear. If an error should occur whilst the test is running then this will be shown clearly on the Display.

Introduction to Clearblue Digital Pregnancy Test

A ‘book’ symbol will appear for a user error such as too much or too little urine sample, and a blank screen will be shown for a device error. The user can therefore be confident that she has interpreted the result correctly.

Women can be certain of their result when using Clearblue Digital Pregnancy Test. The test is over 99% accurate in laboratory tests when used from the day the period is due �, and the result is shown as a definitive ‘Pregnant’ or ‘Not Pregnant’ on the Display thus eliminating uncertainty in interpreting the result*.

For the majority of women, detecting pregnancy as early as possible is clearly an advantage as it enables them to plan appropriately. Market research has shown that women are already testing early, and that others want the choice to carry out a pregnancy test early 2. The Clearblue Digital Pregnancy Test provides women with this benefit by offering the option to test early – up to 4 days before their period is due.

For many women in early pregnancy the amount of pregnancy hormone in their urine is high enough to be detected by Clearblue Digital Pregnancy Test even before their period is due. However, some women may have insufficient pregnancy hormone present for the test to detect whether they are pregnant or not. There is clear information provided on the pack and in the instruction leaflet regarding testing early and what percentage of pregnant women can expect a ‘Pregnant’ result, so the user can make an informed choice about testing early.

New Clearblue Digital Pregnancy Test is the easiest pregnancy test ever

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The new Clearblue Digital Pregnancy Test is the easiest test ever, combining one-step testing with clear results in words, and offering a unique package of benefits to ensure Clearblue’s position as the pregnancy test most trusted by consumers and the brand most recommended by doctors in the UK.

Ease of use and unmistakably clear results – Clearblue Digital Pregnancy Test is now the easiest test ever

* Clearblue Digital Pregnancy Test may also be available with language specific

results, and in some markets the result will be shown in symbols (‘+’ or ‘-‘).

Testing EarlyClearblue recommend that women test from the day their period is due. However, the pregnancy hormone increases rapidly in early pregnancy and Clearblue can be used to test up to 4 days before their period is

due. In clinical testing with early pregnancy samples Clearblue Digital Pregnancy Test gave the following results:

Number of days before the period is due

-�-2-�-4

% of samples from pregnant women giving a ‘Pregnant’ result

9�%90%82%��%

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A woman generally produces a single egg each cycle, which is released from the ovary in a process known as ovulation. Once ovulation has occurred, the egg travels down the Fallopian tube towards the uterus. Within 24 hours of ovulation it is possible for the egg to be fertilised by a sperm.

The fertilised egg then continues to move down the Fallopian tube into the uterus, where it becomes attached to the lining of the uterus. This is known as implantation and generally happens during the week after ovulation.

The pregnancy hormone, human Chorionic Gonadotrophin (hCG), starts to be produced around the time of implantation. The role of hCG is to stimulate production of the hormones progesterone and estrogen. These in turn maintain the uterine lining and prevent menstruation, so allowing the pregnancy to continue. The level of hCG increases rapidly during early pregnancy, doubling every 2 - � days, and soon reaches a level that can be detected in blood and urine.

While the level of hCG can vary between pregnant women, published literature �,4 has shown that the level of hCG is expected to reach at least �0 milli-International Units per millilitre (mIU/ml) on the day the period is due.

The sensitivity of the new Clearblue Digital Pregnancy Test is 2�mIU/ml, enabling pregnancy to be detected up to 4 days before the period is due. For many women in early pregnancy the amount of pregnancy hormone in their urine is high enough for Clearblue Digital Pregnancy Test to detect it even before their

Background Facts about Pregnancy Testing

period is due. However, some women may have insufficient pregnancy hormone present for the test to detect whether they are pregnant or not. If a woman receives a ‘Not Pregnant’ result when testing early it may be because there was too little hormone present to be detected by the test and she should test again on the day her period is due. However if a woman receives a ‘Pregnant’ result when testing early, she can rely on the result. There is clear information provided on the pack and in the instruction leaflet regarding testing early and what percentage of pregnant women can expect a ‘Pregnant’ result, so the user can make an informed choice about testing early.

The graph below shows an example of the rise in hCG in urine from the first detection of pregnancy using an autoimmunoassay (Unipath assay configured onto AutoDelfia (Wallac)). Data is from the cycle of a woman who became pregnant, and was collected from LH surge detection �. NB day 0 is the day the period was due.

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The new Clearblue Digital Pregnancy Test is an integrated one-step test. Each Test Stick incorporates a liquid crystal display (LCD) that shows the result in words - ‘Pregnant’ or ‘Not Pregnant’. In addition the Display illustrates test progression and any error messages with clear symbols.

The technology used in the test is similar to that used in the traditional Clearblue Pregnancy Test. However, the lines produced cannot be read by eye. Instead an optical system is used to measure the density of the lines in the control and result zones in the test. A red light shines onto these specific areas, and the light reflected is converted into an electrical signal.

To perform a Clearblue Digital Pregnancy Test, the user simply removes the one-piece Test Stick from its individual foil wrapper, removes the cap and places the Absorbent Sampler in her urine stream for � seconds. Alternatively she can place the Sampler into a container of urine for 20 seconds. It is important that throughout testing the Test Stick is never held with the Absorbent Sampler pointing upwards.

When urine is applied to the Absorbent Sampler it is detected by the test, which then automatically calibrates itself. A flashing ‘wait’ symbol is shown on the Display demonstrating that the test is working correctly. When the symbol stops flashing, the result will appear.

How the Test Works

The test monitors the control line and once a valid control line has been detected the test line is monitored. Within � minutes the Display will show a ‘Pregnant’ or ‘Not Pregnant’ result. This result will continue to be shown on the Display for approximately 24 hours.

The test has inbuilt control features. It measures the flow of urine. If the urine moves through the test too quickly as a result of over-sampling, or too slowly as a result of under-sampling, then the Display will show a ‘book’ symbol to indicate a user error (this is explained in the instruction leaflet). The error symbol will be displayed for approximately 24 hours. If an error occurs within the test itself, or if the test becomes too wet, the Display will remain blank indicating a device error. In either case the user will need to perform another test.

It is very easy to dispose of the product after use. The battery should be removed from the Test Stick by inserting a coin into the slot on the back of the Test Stick and breaking open the plastic circle containing the battery. The battery should then be disposed of according to the national regulations for battery disposal. The Test Stick should be disposed of with other electronic devices.

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What might affect the Clearblue Digital Pregnancy Test result

There are some factors which might affect the result of the test and the following considerations should be made:

• Although it is not necessary to test with an early morning urine sample when testing on the day the period is due or after, when testing sooner an early morning sample should be used. Whenever the test is done, excessive fluid intake should always be avoided beforehand. A ‘Not Pregnant’ result may be obtained if the urine sample is too dilute

• The manufacturer’s instructions for 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 �4 days) after administration can give a false ‘Pregnant’ result

• Ectopic pregnancy can result when the fertilised egg does not reach the uterus and continues to grow in the Fallopian tube. The production of hCG in an ectopic pregnancy may be lower than in a normal pregnancy and this may lead to 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

Additional Information

• Ovarian cysts, menopause and some very rare medical conditions can give misleading results

• A recent pregnancy, miscarriage or termination can give misleading results. HCG may be found in the body for up to � weeks after birth and can remain in the body for up to 9 weeks after a miscarriage or termination. Whilst hCG remains in the body it is possible for a pregnancy test to detect it and show a false ‘Pregnant’ result

• If a ‘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

• Unexpected results should be discussed with a doctor.

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Unipath – Leaders in Women’s Health Consumer Diagnostics

Unipath is one of the world’s leading women’s health consumer diagnostics organisations. With over �00 employees based at its head office in Bedford, it manufactures a comprehensive and innovative range of women’s health products which are available in more than 80 countries.

Unipath has been active in research, design, production, marketing and sales of women’s health branded diagnostics since its formation in �984. Its market leading range includes Clearblue, and PERSONA and the professional range of rapid clinical tests, including Clearview and Inverness Medical TestPack Plus brands.

Unipath is a division of Inverness Medical Innovations of Waltham Massachusetts, USA. Both companies are pioneers in the area of self-monitoring diagnostics, and under the experienced management of Inverness Medical Innovations, Unipath continues to introduce innovative new products into the diagnostics market.

For more information on the range of products manufactured by Unipath please visit their websites.

Clearblue – www.Clearblue.infoClearview – www.clearview.comTestPack – www.testpack.com

For more information about Unipath please visit www.unipath.com

Unipath’s Product Range

References:� Clearblue has been shown to be over 99% accurate from the day the period is due when compared to a reference method in laboratory studies using urine samples supplied for pregnancy testing. Reference method used: Perkin Elmer Delfia hCG.2 Unipath market research (200�) - data on file� Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human Chorionic Gonadotrophin from the time of implantation until the second week of pregnancy. Fertil. Steril. �982;�� (�) :���-84 Chard T. Pregnancy tests – a review. Hum.Reprod. �992;� (�): �0�-�0� Miro, F.M., et al. Dynamics of urinary levels of hCG in early pregnancy. Manuscript in preparation.

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Unipath Ltd, Bedford, MK44 �UP, UKClearblue is a trademark.

Unipath is a division of Inverness Medical Innovations.©Unipath 200�