BABYCHECK-1 WB

Overview

Rapid self-test for detection of hCG (pregnancy) in blood.

BABYCHECK-1 WB test is a self-testing rapid test for the determination of the hCG  (human Chorionic Gonadotropin) in whole blood sample for the diagnosis of pregnancy.

While pregnancy can be detected in urine about 1 week after a missed period, whole blood testing can detect pregnancy as early as a few days after impregnation.

Pregnancy whole blood tests are also known to be more accurate than urine tests. This is the reason why whole blood/serum pregnancy tests are widely used in laboratories/hospitals.

In addition, the volume of ingested liquids which may affect the urine test results (dilution of hCG) is not affecting whole blood test. The test accuracy is indeed very important as a pregnancy necessarily implies precautions as well as a change in lifestyle such as stopping smoking or drinking alcohol, reducing or even eliminating medications as well as certain foods. It is possible to detect an hCG concentration of 25 IU/L.

Who is the test for?

 For individuals aiming to assess their hCG level for pregnancy confirmation, a result equal to or exceeding 25 IU/L signifies a positive pregnancy indication.

How to use

  1. Prepare the test device, the pipette and the diluent dropper vial. Take them out from the protective pouch (tear at the notch. Remove the screw cap of the diluent dropper vial and leave it nearby).
  2. Clean the tip of the middle finger or ring finger with cotton wool moistened with alcohol. Press the lancet firmly against the side of the previously cleaned finger and press the release button.
  3. Without pressing the bulb, put in contact the plastic pipette with the blood sample. The whole blood migrates into the pipette through capillarity to the line indicated on the pipette.
  4. Dispense the blood into the sample well of the cassette, pressing down on the bulb of the pipette. Wait 30-40 seconds for blood absorption. Unscrew the blue capfrom the dropper bottle, keeping the white cap secure. Add 4 drops of diluent to the well, spacing each drop 2-3 seconds apart. Read the result within 5 to 10 minutes. Do not interpret after 10 minutes.

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Results and recommendations

Analyze

Result

Summery

  The test is positive
Two coloured lines appear in thewindow under the marks T (Test) and C (Control). Thecolour intensity of the T line may be clearer than theintensity of the C line. The test is positive indicating thatthe hCG level is than 25 IU/L or higher and that you arepregnant.
 Test is negative
Only one coloured line appearsunder the mark C (Control). The test is negativeindicating that the hCG level is below 25 IU/L.
 Invalid result
No line appears or a coloured lineappears under the mark T (Test) without any lineunder the mark C. In this case, it is not possible tointerpret the test, which must be considered as invalid.It is recommended to repeat the test with anotherBABYCHECK-1® WB test and new blood sample.

Questions and answers

How does BABYCHECK-1® WB work?

When a woman becomes pregnant, her body begins to produce a hormone, human chorionic gonadotropin (hCG), which is released in the blood where its concentration rises over time. BABYCHECK-1® WB Pregnancy test detects the hCG hormone in blood. The BABYCHECK-1® WB test uses a specific pair of antibodies detecting the hCG hormone in blood when the hormone level is, at least, 25 IU/L (determined against W.H.O.* reference) or greater.

*World Health Organization

You can use the BABYCHECK-1® WB Pregnancy test any time of day ornight. BABYCHECK-1® WB test can detect pregnancy earlier than a classicalurine test because the hCG hormone produced in the placenta is firstreleased in the blood flow and then into the urine. Therefore, there is nomore limitation to collect the morning first urine in order to increase theprobability of an early pregnancy detection.
The results are accurate as long as the instructions are carefully respected.Nevertheless, the result can be incorrect if BABYCHECK-1® WB test gets wetbefore test performing or if the quantity of blood dispensed in the samplewell is not correct. The plastic pipette provided in the box makes sure thecollected blood volume is correct. Certain drugs containing hCG or which are used in combination with hCG(such as Pregnyl, Porfasi, Pergonal) and rare medical conditions may leadto a false positive result. Alcohol, analgesics, antibiotics, birth controlpills, hormone therapies containing clomiphene citrate (such as Clomid,Serophen) or painkillers should not affect the test result. The test may show a false positive result if you have had a miscarriage,abortion or have given birth within the past 8 weeks. This is due to the test detecting hCG still present in your body.
The colour and intensity of the lines have no importance for resultinterpretation. The lines should only be homogeneous and complete. Thetest should be considered as positive whatever the color intensity of the testline (T), even weak.
When this line appears, it only means that the test has been performed well.
No. The result should be read within 5 minutes after adding the diluent. Theresult is reliable up to 10 minutes.
If the result is positive, you should consult your general practitioner and/orgynecologist to discuss about your pregnancy and next steps. Early prenatalcare is important for a safe follow up of pregnancy.
If the test is negative, it is most likely that your blood does either notcontain hCG or very low levels of hCG (the test detects hCG concentrationas low as 25 IU/L) and that you are most probably not pregnant. However,you may have miscalculated the date of your period, especially if you haveirregular periods. If your period does not start within a week, repeat thetest. If you still get a negative result and your period has not started, youshould consult your general practitioner or gynecologist. This delay could becaused by other reasons

The BABYCHECK-1® WB test is accurate. Evaluation reports show an overall agreement higher than 98% [95.2 – 99.5**] with reference methods. Although this test is reliable, false positive or false negative results could be obtained.

** CI 95%: 95% Confidence Interval.