Note: Sample Line False results may occur if urine level goes above Sample Note: Line False results may occur if urine level goes above Sample Line Positives can be read as soon as the control line appears Positives can be read as soon as the hCG-Urine Test ® Rev.
KEY TO COmPONENT LABELING Use by YYYY-MM Batch code Catalog number Contents sufficient for tests In vitro diagnostic medical device Temperature limitation Manufacturer/Manufactured by Consult instructions for use Authorized representative in the European Community Caution, consult accompanying documents.
® hCG-Urine Test CLIA Complexity: Waived FOR LABORATORY AND PROFESSIONAL IN VITRO DIAGNOSTIC USE ONLY Intended Use For the qualitative determination of human chorionic gonadotropin (hCG) in urine for early detection of pregnancy. Summary and Explanation of Test The hormone hCG is produced by the placenta (1) . Urine hCG provides an early indication of pregnancy.
• • • • Because of the high degree of sensitivity of the assay, specimens tested as positive during the initial days after conception may later be negative due to natural termination of the pregnancy. Overall, natural termination occurs in 22% of clinically unrecognized pregnancies and 31% of other pregnancies (12) . In the presence of weakly positive results, it is good laboratory practice to sample and test again after 48 hours.
Performance Characteristics Sensitivity Urine specimens containing as low as 25 mIU/mL hCG (calibrated against WHO 3rd IS 75/537) will yield positive results when tested with the OSOM hCG-Urine Test. Interference Testing The following substances were tested individually in hCG-free urine and urine containing 25 mIU/mL hCG.
REFERENCES 1. Seifer, D.B., and Flynn, S.D., Clinical Application of Human Chorionic Gonadotropin, in Clinical Diagnosis & Management by Lab Methods, Henry, J. B., Ed., W. B. Saunders Co., Philadelphia, 1991, 474. 2. Lenton E.A., Neal, L.M., and Sulaiman, R., Plasma Concentrations of Human Chorionic Gonadotropin from the Time of Implantation Until the Second Week of Pregnancy, Fertility and Sterility, 37, 773, 1982. 3.
