The hCG One Step Pregnancy Combo Test Device (Urine/Serum)

Short Description:

The hCG One Step Pregnancy Combo Test Device (Urine/Serum) is composed of the glass fiber strips of monoclonal antibody against human chorionic gonadotropin (hCG), anti-mouse IgG solid cellulose nitrate membrane and the bonders of absorptive colloidal gold – monoclonal antibody against hCG. It adopts the principles of double antibody sandwich method and immunochromatography to test the hCG in the urine and serum.

The hCG One Step Pregnancy Test Device/strip (Urine) is a rapid, one-step lateral flow immunoassay in device format for the qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated levels of hCG. The assay is conducted by adding urine to the specimen well, and obtaining the result from the colored lines.

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PRECAUTIONS

Please read all the information in this package insert before performing the test.
Do not use after the expiration date printed on the foil pouch.
Store in a dry place at 2-30°C or 36-86°F. Do not freeze.
Do not use if pouch is torn or damaged.
Keep out of the reach of children.
For in vitro diagnostic use. Not to be taken internally.
Do not open the test foil pouch until you are ready to start the test.
The used test should be discarded according to local regulations.

INSTRUCTIONS

1.Remove the test device from the foil pouch and familiarize yourself with the product.

2.Hold the dropper vertically and transfer 3 full drops of samples to the specimen well (S) of the test device, and then begin timing. Avoid trapping air bubbles in the specimen well (S). See

illustration below.

3.As the test begins work, you may notice a light colored flow moving across the test line region (T) and control line region (C) on the test device. Read the result at 5 minutes. If no colored line appears, wait 1 minute longer. Some positive results may be observed in 1 minute or less depending on the concentration of hCG. Do not read the result after 10 minutes.

QUESTIONS & ANSWERS

1.Q: How does the test work?
A: The hCG One Step Pregnancy Combo Test Device detects a hormone in your
urine or Serum that your body produces during pregnancy (hCG-human chorionic
gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.
2.Q: How soon after I suspect that I am pregnant can I take the test?
A: You can test your urine as early as the first day you miss your period. You can perform the
test anytime of the day; however, if you are pregnant, first morning urine contains the
most pregnancy hormone.
3.Q: Do I have to test with first morning urine?
A: Although you can test at any time of the day, your first morning urine is usually the most
concentrated of the day and would have the most hCG in it.
4.Q: How do I know that the test was run properly?
A: The appearance of a colored line in the control region (C) tells you that you followed the
test procedure properly and the proper amount of urine was absorbed.
5.Q: What should I do if the result shows that I am pregnant?
A: It means that your urine or serum contains hCG and you are probably pregnant. See your
doctor to confirm that you are pregnant and to discuss the steps you should take.
6.Q: What should I do if the result shows that I am not pregnant?
A: It means that no hCG has been detected in your urine or serum and probably you are not
pregnant. If you do not start your period within a week of its due date, repeat the test with
a new test device. If you receive the same result after repeating the test and you still do not get your period, you should see your doctor.