One Step HCG Test Cassette
CE 0197 Mark
hcg rapid test is for the qualitative detection of human chorionic gonadotropin (hCG) in urine.
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.
SUMMARY
Human chorionic gonadotropin (hCG) is a glycoprotein hormone secreted by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both serum and urine as early as 7 to 10 days after conception (1 – 4 ). HCG levels continue to rise very rapidly, frequently exceeding 100 mIU/ml by the first missed menstrual period ( 2 – 5 ), and peaking in the 100 - 200 mIU/ml range about 10 – 12 weeks into pregnancy. The appearance of hCG in both the urine and serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. The hCG One Step Pregnancy Tests is a rapid urine test to qualitatively detect the presence of hCG in urine specimens at the sensitivity of 25 mIU/ml. The test utilizes monoclonal antibody to selectively detect elevated levels of hCG in urine. At the level of claimed sensitivity, hCG One Step Pregnancy Test shows no cross – reactivity interference from the structurally related glycoprotein hormones hFSH, hLH and hTSH at physiological levels.
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.
