U-Chek

HCG Pregnancy Test Kit – Midstream


Description

U-CHEK (One step HCG Pregnancy Test) is a self-performing immunoassay designed for the qualitative determination of human chorionic gonadotropin (HCG) in urine for early detection of pregnancy. This product is in the format of midstream. This is packed and sealed in aluminum foil bags to ensure its validity before its expiration.

Human Chorionic gonadotropin (HCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. During normal pregnancy, HCG can be detected in urine as early as 7 days following conception, doubling every 1.3 to 2 days. At the time of the last missed menstrual period, urine HCG levels are about 100mlU/ml with peak levels of 100,000 to 200,000mlU/ml seen at the end of the first trimester. The presence of HCG soon after conception and its subsequent increase in concentration during early gestational growth make it an ideal marker for the early detection of pregnancy.

The method employs a unique combination of monoclonal dye conjugate and polyclonal-solid phase antibodies to selectively identify the HCG in the test samples with an extremely high degree of sensitivity. In less than 5 minutes, levels of HCG as low as 25mlU/ml can be detected.

As the test sample flows through the absorbent device, the labeled antibody-dye conjugate binds to the HCG forming an antibody-antigen complex. This complex binds to the anti-HCG antibody in the positive reaction zone ("T" area) and produces a pink-purple colored band when the HCG concentration is greater than 25mlIU/ml. In the absence of HCG, there is no line in the positive reaction zone. Unbound conjugate binds to the reagents in the control zone ("C" area), producing a pink-purple band, demonstrating that the reagents are functioning properly.

Intended Use

U-CHEK is used for early diagnosis of pregnancy.

Instructions for use

Test Procedure

Interpretation of results

Positive: If two pink lines appear both in the control area and test area, you can assume that you are pregnant.

Negative: If only one pink line appears in the control area, you can assume that you are not pregnant.

Inconclusive: If there is no distinct pink-purple colored band visible both in the TEST area and CONTROL area the test is inconclusive. It is recommended that in this case the test be repeated right now.

Warning and Precautions

For In Vitro Diagnostic use only

Packaging Presentation

U-CHEK is packed in an aluminium foil pouch with desiccant. Each such Pouch is packed in a box with operating instruction.