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HCG Test
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HCG Urine Cassette

Catalog No.            Product Name

ABT-IDT-B6            HCG Urine Cassette


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

PERFORMANCE CHARACTERISTICS
Sensitivity:
The Pregnancy Test 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.
Hook Effect:
There was no hook effect at hCG levels up to 600,000 mIU/ml in urine or serum.
Accuracy:
URINE:

Urine samples from normal women (n=61) and pregnant women (n=66) were tested with the Pregnancy Test 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.
SERUM:

Serum samples containing no detectable hCG (n=70) and hCG positive serum (n=154) were tested with the Pregnancy Test and the reference laboratory test. A 99.6% correlation was observed between the two tests. No false positive or false negative results were obtained. The accuracy of the test was >99% in serum.
Specificity:
The specificity of the Pregnancy Test 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.
STANDARDIZATION
The sensitivity of the Pregnancy Test was established using urine standards calibrated to the WHO 3rd IS 75/537 and the WHO 1st IRP 75/537 respectively.

LIMITATIONS

1. A number of conditions, other than pregnancy, including trophoblastic disease and certain non-trophoblastic neoplasm cause elevated levels of hCG. These conditions should be considered with appropriate clinical evidence.
2. A dilute urine specimen may not contain sufficient levels of hCG to give a positive result. If pregnancy is still suspected, a first morning urine should be obtained from the patient 24-48 hours later and retested.
3. As with all diagnostic tests, a definitive clinical diagnosis should not be based on the result of a single test, but should only be made by the physician after all clinical and laboratory findings have been evaluated