 PREGNANCY ASSAY COMBO TEST |
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| PURPOSE AND PRINCIPLE : |
| The PREGNANCY ASSAY is, a colloidal gold antibody complex based chromatographic immunoassay, used for the qualitative determination of human chorionic gonadotropin (HCG) in serum or urine. This test is for professional use in obtaining a visual qualitative result for the early detection of pregnancy. |
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| SENSITIVITY AND SPECIFICITY : |
| The PREGNANCY ASSAY employs a combination of monoclonal and ployclonal antibodies to selectively identify HCG in the samples with a high degree of sensitivity. In less than 5 minutes , elevated levels of HCG equal to or greater 25 mIU/mL can be detected. At the level of claimed sensitivity, the PREGNANCY ASSAY shows no cross reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at high physiological levels. |
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| PRINCIPLE : |
| .............. Diffuse through the |
| (a) Urine--------------------------- > + anti-HCG antibodies-dye conjugate == > HCG Ag-Ab complex |
| absorbent reaction pack ........ (red color) |
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| Migrates via capillary action |
| (b) HCG Ag-Ab complex ------------------------------------ > + anti-HCG antibody == > |
| along the membrane |
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- A red line in the testing reaction zone (T): HCG>=25 mIU/mL.
- No line in the testing reaction zone (T): absence of HCG.
- A red line in the control reaction zone (C): the reagent and reaction pack is functioning correctly.
- No red line in the control reaction zone (C): the reagent and reaction pack is functioning invalidly.
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