The only test to reassure from start to finish

Pregnancy Test

Confidence and certainty inhome pregnancy testing - nowwith the additional reassuranceof a sample indicator - ColourChange TipWhat does a woman want from a pregnancy test?Whether the prospect of pregnancy provokes panic, stre s s,excitement or joy, she wants a clear result that is accurate.That’s why women trust Clearblue Pregnancy Tests.

Now, the Clearblue Pregnancy Test provides an addedbenefit – the reassurance of a unique Colour ChangeTip that turns completely pink to show that urine isbeing absorbed.

Therefore Clearblue Pregnancy Test with ColourChange Tip provides reassurance from start to finish: • Unique Colour Change Tip quickly turns pink to show

that urine is being absorbed.• A line in the Control Window indicates that the test

has worked.

Clearblue Pregnancy Test also provides certainty: • More than 99% accurate in laboratory tests when

used from the day the period is due.• Sensitive enough (25mIU/ml) to offer women the

choice of testing up to 4 days before their period is due.• Clear ‘Pregnant’ ( + ) or ‘Not Pregnant’ ( – ) result,

with a result key on the Test Stick to aid interpre t a t i o n .

This improved test is available to the consumer at thesame recommended retail price as the previousClearblue Pregnancy Test.

Pregnancy Test

The new Clearblue Pregnancy Test with Colour ChangeTip offers a unique combination of features, ensuringthe position of Clearblue as the pregnancy test mosttrusted by consumers and the brand mostrecommended by doctors in the UK. ClearbluePregnancy Test with Colour Change Tip putslaboratory-quality science into the hands of consumersin an easy-to-use, reliable and user-friendly way.

The Clearblue Pregnancy Test with Colour Change Tipdetects the hormone human Chorionic Gonadotrophin(hCG) in urine and works in a similar way to manyhospital tests. This hormone starts to be producedrapidly in the early stages of pregnancy. ClearbluePregnancy Test is now sensitive enough to detect hCGup to 4 days before a woman’s period is due, thereforeproviding her with the option of testing early.

Clearblue Pregnancy Test is quick and easy to use,producing a reliable result in just 2 minutes. The ColourChange Tip quickly turns pink to show that urine isbeing absorbed. This helps give the user extrareassurance when she performs the test.

After 2 minutes the result is ready to read. A blue linein the Control window gives the user confirmation thatthe test has worked.

In the Result Window a ‘+’ symbol tells the user she ispregnant, or a ‘-’ symbol tells her she is not. Thissimple ‘+’ or ‘-’ result means that the user will findClearblue Pregnancy Test with Colour Change Tipexceptionally easy-to-read and gives greater clarity inthe result.

Clearblue Pregnancy Test nowoffers the choice of testing up to4 days early.For the majority of women, detecting pregnancy asearly as possible is clearly an advantage as it enablesthem to plan appropriately. Market research has shownthat over one third of women are already testing early,and that others want the choice to carry out apregnancy test early1. The Clearblue Pregnancy Testp rovides women with this benefit by offering the optionto test early – up to 4 days before their period is due.

For many women in early pregnancy the amount ofpregnancy hormone in their urine is high enough to bedetected by Clearblue Pregnancy Test even before theirperiod is due. However, some women may haveinsufficient pregnancy hormone present for the test to

detect whether they are pregnant or not. There is clearinformation provided on the pack and in theinstruction leaflet regarding testing early and whatpercentage of pregnant women can expect a‘Pregnant’ result, so the user can make an informedchoice about testing early.

Clearblue Pregnancy Test nowwith Colour Change Tip - aninnovation designed to meetwomen’s needs Even before the introduction of the Colour Change Tip,market research had shown women had a very positiveview of Clearblue Pregnancy Test. Over 90% found thetest easy to use, saying that it gave a clear result,providing them with confidence in the result2. The newClearblue Pregnancy Test with Colour Change Tip hasbeen developed in order to build and support thatconfidence even further.

The Clearblue Pregnancy Test has been proven inextensive laboratory studies to be more than 99%accurate in detecting the hormone hCG – from the daya woman’s period is due.3 In the UK, Clearblue is thepregnancy test most recommended by doctors.

Pregnancy Testing background factsFertilisation and early pregnancy A woman generally produces a single egg each cyclewhich is released from the ovary, a process known asovulation. Once ovulation has occurred the egg travelsdown the Fallopian tube towards the uterus. Within 24hours of ovulation it is possible for the egg to befertilised by a sperm.

The fertilised egg then continues to move down theFallopian tube into the uterus, where it becomesattached to the lining of the uterus. This is known asimplantation and generally happens during the weekafter ovulation.

The pregnancy hormone human ChorionicGonadotrophin (hCG) starts to be produced aroundthe time of implantation. The role of hCG is tostimulate production of the hormones progesteroneand oestrogen. These in turn maintain the uterinelining and prevent menstruation, so allowing thepregnancy to continue.

The level of hCG increases rapidly during earlypregnancy, doubling every 2 - 3 days, soon reaching alevel that can be detected in blood or in urine. Basedon published literature, this level is expected to reachat least 50mIU/ml on the day the period is due.4,5

The Clearblue Pregnancy Test is now sensitive enoughto give women the option of testing before their periodis due. The sensitivity of the Clearblue Pregnancy Testis 25mIU/ml when read at 2 minutes.

The graph below shows an example of the rise in hCGin urine from first detection of pregnancy using anautoimmunoassay (Unipath assay configured ontoAutoDelfia (Wallac)). Data is from the cycle of a womanwho became pregnant, and was collected from LH surg edetection6. NB day 0 is the day the period was due.

Testing EarlyC l ea r b l u e recommend that women test from the daytheir period is due. However, the pregnancy horm o n ei n c reases rapidly in early pregnancy and C l ea r b l u e c a nbe used to test up to 4 days before their period is due.

In clinical testing with early pregnancy samplesC l ea r b l u e gave the following re s u l t s :

Number of days beforethe period is due

% of samples fro mp regnant women giving

a ‘Pregnant’ re s u l t

-1-2-3-4

87%84%74%53%

How does the ClearbluePregnancy Test with ColourChange Tip work?Please note these are abbreviated instructions. A user mustalways read the in-pack leaflet before carrying out a test.

If testing from the day the period is due, the user cantest at any time of the day. If testing early, the firsturine of the day should be used.

The user holds the Colour Change Tip in her urinestream, or dips it into a collected sample for 5 seconds.The Colour Change Tip will quickly turn pink to showthat urine is being absorbed.

After 2 minutes the result is ready to read. A blue line i nthe Control Window indicates that the test has worked. Ahorizontal blue line appears in the Result Wi n d o w. If hCGis present in the urine, it will react with antibodies in thetest to form a vertical blue line in the Result Window.These lines will produce a ‘Pregnant’ ( + ) symbol inthe Result Window that tells the user she is pregnant.

If there is no hCG or insufficient hCG to be detected inthe urine, only the horizontal blue line appears. Thisproduces a ‘Not Pregnant’ ( – ) symbol that tells theuser she is not pregnant.

If testing early it may be that there is insufficientpregnancy hormone in the urine to be detected. It isrecommended that a further test is done when theperiod is due.

Clearblue Pregnancy Test with Colour Change Tipprovides women with:• A result that is more than 99% accurate when used

from the day the period is due.3

• A clear ‘Pregnant’ ( + ) or ‘Not Pregnant’ ( – ) resultin just 2 minutes, with a result key on the Test Stick to aid interpretation.

• A test that is sensitive enough to be used up to 4 days before the period is due.

• A test that incorporates reassurance from start to finish.

Additional points• Excessive fluid intake should be avoided before testing.• Clearblue Pregnancy Test results should be read

within 10 minutes of doing a test. Any changes afterthis should be disregarded.

• The manufacturers’ instructions for any medication being taken should be read before conducting a test.

• Fertility drugs containing hCG can give misleading results (these fertility drugs are usually given by injection and testing too soon after administration may give a false ‘Pregnant’ result).

• Other fertility therapies (such as clomiphene citrate),painkillers and hormonal contraceptives (e.g. contraceptive pill) should not affect the result.

• If a woman has recently stopped using hormonal contraception or is using fertility therapies like clomiphene citrate, her periods may be irregular,leading her to test too soon.

• If a woman has recently been pregnant (even if not carried to full term) she may get a false ‘Pregnant’ result.

• Ectopic pregnancy, ovarian cysts, menopause, and some very rare medical conditions can give misleading results.

• Unexpected results should be discussed with a doctor.• If a woman has a ‘Pregnant’ result it is possible that

she later finds that she is not pregnant due to natural loss of the pregnancy which can occur in theearly stages.

R e f e re n c e s :1 Unipath Market Research (2005) – data on file2 Evaluation of C l ea r b l u e P regnancy Test with 100 women. 3 C l ea r b l u e has been shown to be over 99% accurate when compared

with a quantitative method for hCG in laboratory studies using urine samples supplied for pregnancy testing. Unipath data on file.

4 Lenton EA, Neal LM, Sulaiman R. Plasma concentrations of human Chorionic Gonadotrophin from the time of implantation until the second week of pre g n a n c y. Fertil. Steril. 1982;37(6): 773-8.

5 Chard T. Pregnancy tests – a re v i e w. Hum. Reprod. 1992;7(5):701-106 Miro, F.M., et al. Dynamics of urinary levels of hCG in early pre g n a n c y.

Manuscript in pre p a r a t i o n .

Unipath Ltd, BedfordMK44 3UP, UK.

Clearblue is a trademark.

Unipath is part of the Inverness Medical Innovations Group.

February 2006.