High Accuracy HCG Pregnancy Test strip, 3mm strip, urine specimen, professional use

INTENDED USE:

One Step HCG pregnancy Urine Test strip is a rapid pregnancy test, which you can easily carry out yourself. It detects the presence of human chorionic gonadotropin ("HCG"), which appears in urine very early during pregnancy. For in vitro self-testing use only. For external use only.

TEST PRINCIPLE:

Human chorionic gonadotropin (hCG) is a hormone, produced by the developing placenta shortly after the conception and secreted into the urine. The pregnancy test contains antibodies which specifically react with this hormone. When the strip is immersed into a urine specimen, capillary action carries the specimen to migrate along the membrane. When hCG in the sample reaches the test zone region of the membrane, it will form a colored line. Absence of this colored line suggests a negative result. To serve as a procedure control, a colored line will appear at the control zone region, if the test has been performed properly

TEST PROCEDURE

1. The test strip and urine have to be at room temperature (15-30°C) for testing.

2. Remove the test strip from the sealed pouch.

3. Immerse the strip into the urine with the arrow pointing towards the urine. Take the strip out after 3 seconds and lay the strip flat on a clean, dry, nonabsorbent surface (such as the mouth of the urine container). IMPORTANT Do not allow the urine level to exceed the MAX (marker line), otherwise the test will not perform correctly.

4. Read results in five minutes. Do not read results after more than 5 minutes.

LIMITATIONS:

1. As it is with any diagnostic procedure, a confirmed pregnancy diagnosis should only be made by a physician after evaluating all clinical and laboratory findings.
2. If a urine sample is too dilute (ie. low specific gravity) it may not contain a representative level of hCG. If pregnancy is still suspected, another urine specimen should be collected 48 hours later and tested.
3. Low concentration of hCG in a very early pregnancy can give a negative result. In this case, another specimen should be obtained at least 48 hours later and tested.
4. Elevated levels of hCG can be caused by a few conditions other than pregnancy. Therefore. the Presence of hCG in urine specimen should not be used to diagnose pregnancy unless these conditions have been ruled out.
5. A normal pregnancy can not be distinguished from an ectopic pregnancy based on hCG levels alone Also, spontaneous miscarriage may cause confusion in interpreting test results.
6. Sterility treatments, based on hCG. may cause false results. Consult your physician