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INTRODUCTION

One step hCG is a qualitative, two site sandwich immunoassay for the detection of Human Chorionic Gonadotropin (hCG), which is a marker for pregnancy, in human urine samples. hCG is a glycoprotein hormone which is secreted by viable placental tissue during pregnancy. The appearance of hCG in urine soon after conception and its rapid rise in concentration makes it an ideal marker for early detection and confirmation of pregnancy. The concentration of hCG continues to rise rapidly, frequently exceeding 100 mIU/ml by the first missed menses and peaking in the 30,000 ~ 100,000 mIU/ml range by 10 to 12 weeks into pregnancy. The test is very rapid and sensitive, that the results are interpreted by the end of five minutes. Test results can be read visually without any instrumentation.

 PRINCIPLE:

hCG, One Step Pregnancy Test is a membrane based immunochromatographic test. The membrane contains a test region “T” coated with goat anti- hCG monoclonal antibodies and a control region “C” coated with goat anti-rabbit antibodies. When the test sample flows through the membrane assembly, the anti- hCG monoclonal antibody-colloidal gold conjugate complexes with the hCG present in the sample. This complex moves further on the membrane and gets immobilized at the test region by the anti-hCG coated on the membrane, leading to the formation of a pink/purple coloured band at “T”, confirming a positive result. Absence of this band indicates a negative result. The unreacted conjugate moves further on the membrane assembly and ends up forming the control line at “C”, immobilized by the anti-rabbit antibodies. This control band “C” served to validate the test result. No band at “C” indicates that the test is invalid.
Instructions for Use:
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