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Rapid HCG Pregnancy Test Cassettes
Rapid HCG Pregnancy Test Cassettes

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1.CE0197 Mark. 2. HCG the early detection pregnancy.
3 For qualitative detection of human chorionic gonadotropin
(hCG) i

INTENDED USE
One Step hCG Pregnancy Test Cassette is a rapid chromatographic immunoassay for the qualitative detection of human chorionic gonadotropin (hCG) in urine, as an aid for the early detection of pregnancy.

 

PRINCIPLE
The hCG One Step Pregnancy Test is a qualitative, solid phase, two-site sandwich immunoassay (5 – 6 ) for the detection of human chorionic gonadotropin (hCG) in urine. The membrane is pre-coated with anti-hCG antibodies on the test line region and anti-mouse antibodies on the control line region. During testing, the urine sample reacts with the dye conjugate that has been pre-coated in the test device. The mixture migrates upward on the membrane chromatographically by capillary action to react with anti-hCG antibodies on the membrane and generate a red line. Presence of this red line indicates a positive result, while its absence indicates a negative result. Regardless of the presence of hCG as the mixture continues to migrate across the membrane to the immobilized goat anti-mouse region, a red line at the control line region will always appear. The presence of this red line serves as verification for sufficient sample volume and proper flow and as a control for the reagents.

 

PERFORMANCE CHARACTERISTICS
Sensitivity: One Step hCG Test Cassette detects urine hCG concentrations of 25 mIU/ml. A total of 180 tests were performed, at the three hCG concentrations. hCG specimens were prepared at the following concentrations using hCG free urine; 0 mIU/ml,25 mIU/ml and 600,000 mIU/ml. All tests were negative with the hCG negative urine and positive with the 25 mIU/ml and 600,000 mIU/ml samples.
Specificity: The specificity of One Step hCG Test Cassette was determined from cross reaction studies with known amounts of Luteinizing Hormone (hLH), Follicle Stimulating Hormone (hFSH), and Thyroid Stimulating Hormone (hTSH). Samples containing 300 mIU/ml hLH, 1000 mIU/ml hFSH and 1000 mIU/ml hTSH all gave negative results.
Accuracy: The accuracy of One Step hCG Test Cassette was determined by comparing with the results of a reference laboratory test, as follows: Urine samples from normal women (n=61) and pregnant women (n=66) were tested with One Step hCG Test Cassette and the reference laboratory test. A 100% correlation was observed between the two tests. No false positive or false negative results were obtained. The accuracy of the test was >99% in urine.

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