Rapid self-test for the detection of hCG (pregnancy) in blood
Intended Purpose
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.
General Points
BABYCHECK-1®WB test is a manual qualitative immunochromatographic screening test for the detection of hCG (human Chorionic Gonadotropin) in women finger prick blood sample. It can be used at home by lay users for self-testing for the detection of pregnancy.
While pregnancy can be detected in urine about 1 week after a missed period, blood testing can detect pregnancy as early as 10 days after impregnation.
Pregnancy blood tests are also known to be more accurate than urine tests. This is the reason why 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 a 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.
In only 5 minutes, it is possible to detect an hCG concentration of 25 IU/L or higher.
Test Procedure
Prepare everything properly before starting the testing procedure. Place the content of the box on a clean, dry and flat surface (e.g. table). Then perform the test as follows:
- Wash your hands thoroughly. Use soap and warm water. Dry your hand with clean towel.
- Prepare the test device and capillary pipette: Take them out from the protective pouch (tear at the notch) and place them in the reach of your hands (you will need them later). Discard the desiccant bag.
- Prepare the lancet. Hold the lancet without touching the trigger button. Unlock the cap twisting it off ¼ turn until you feel it separates from the lancet and then continue twisting it (2-3 rotations). Don’t pull just twist and discard the cap when finished. ①②
- Clean the end of the middle or ring finger with cotton damped with alcohol. Massage the chosen finger towards the tip for 10 to 15 seconds to enhance the blood flow.
- Prick the finger: put the lancet firmly against the side of the previously cleaned finger, and press the release trigger button.③ The lancet will automatically retract into the body of the device. Gently massage the finger to create a nice round blood droplet.④
- Collect the blood with the capillary pipette: Gently touch the blood droplet with the open end of the capillary pipette. It must be filled until the line indicated on the capillary pipette. Do not press the bulb, it fills by itself. Make another blood droplet if the line is not reached. As far as possible, avoid air bubbles. ⑤
- Put the blood collected with the pipette into the sample well of the device, by pressing on the pipette bulb. ⑥
- Wait 30-40 sec for the blood being totally absorbed into the sample well.
- Add the diluent: Unscrew the blue cap of the diluent dropper vial (leave the white cap tightly screwed) and add the diluent as follows: Hold the diluent dropper vial vertically and slowly add exactly 4 drops in the sample well of the device with an interval of 2-3 seconds between each drop. ⑦
- Read the result after 5 minutes. Do not interpret after 10 minutes.
Results Interpretation
The colour and intensity of the lines do not have any importance for the interpretation of the test results.
Analyze
Result
Summary
Positive result
Negative result
Invalid result
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, 25I U/L (determined against W.H.O.* reference) or greater.
*World Health Organization
When should the test be performed?
You can use the BABYCHECK-1® WB Pregnancy test any time of day or night. BABYCHECK-1® WB test can detect pregnancy earlier than a classical urine test because the hCG hormone produced in the placenta is first released in the blood flow and then into the urine. Therefore, there is no more limitation to collect the morning first urine in order to increase the probability of an early pregnancy detection.
Can the result be incorrect?
The results are accurate as long as the instructions are carefully respected. Nevertheless, the result can be incorrect if BABYCHECK-1® WB test gets wet before test performing or if the quantity of blood dispensed in the sample well is not correct. The plastic pipette provided in the box makes sure the collected blood volume is correct.
Certain drugs containing hCG and medical conditions such as cancer or uterine malignancies may lead to a false positive result.
The test may also 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.
How to interpret the test if the colour and the intensity of the T and C lines are different?
The colour and intensity of the lines have no importance for result interpretation. The lines should only be homogeneous and complete. The test should be considered as positive whatever the color intensity of the test line (T), even weak.
What is the line that appears under the mark C (Control) for?
When this line appears, it only means that the test has been performed well.
If I read the result after 10 minutes, will the result be reliable?
No. The test should be read 5 minutes after adding the diluent. The result is reliable up to 10 minutes.
What do I have to do if the result is positive?
If the result is positive, you should consult your general practitioner and/or gynecologist to discuss about your pregnancy and next steps. Early prenatal care is important for a safe follow up of pregnancy.
What do I have to do if the result is negative?
If the test is negative, it is most likely that your blood does either not contain hCG or very low levels of hCG (the test detects hCG concentration as 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 have irregular periods. If your period does not start within a week, repeat the test. If you still get a negative result and your period has not started, you should consult your general practitioner or gynecologist. This delay could be caused by other reasons.
What is the accuracy of BABYCHECK-1® WB?
The BABYCHECK-1® WB test is accurate. Evaluation reports show an overall agreement of 100% (CI95% [96.16 – 100.0]**) with reference methods. Although this test is reliable, false positive or false negative results could be obtained.
** CI 95%: 95% Confidence Interval.