Sure-Vue - rapid chromatographic immunoassay
Performed at authorized locations by point of care operators. Human Chorionic Gonadotropin (HCG) detection is most often used to confirm pregnancy.
Negative results are expected in healthy non-pregnant women and healthy men.
•False negative results may occur when the levels of hCG are below the sensitivity level of the test. Diluted urine specimens with low specific gravity may not contain enough hCG for detection. If pregnancy is still suspected, a first morning specimen should be obtained.
•A number of conditions other than pregnancy, including trophoblastic disease, and certain non-trophoblastic neoplasms; including testicular tumors, prostate tumors, breast cancer and lung cancer cause elevated levels of hCG.
•This test reliably detects intact hCG up to 500,000 mIU/mL. It does not reliably detect hCG degradation products, including free-beta hCG and beta core fragments. Quantitative assays used to detect hCG, may detect hCG degradation products and therefore may disagree with the results of this rapid test.
• This test provides a presumptive diagnosis for pregnancy. A confirmed pregnancy diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
•Obtain a midstream, clean-catch urine specimen. Concentrated first morning specimens are preferred.
•Urine specimens exhibiting visible precipitates should be centrifuged or allowed to settle to obtain a clear specimen.
For more test specific information, please refer to the test procedure found on the Michigan Medicine POC website: https://www.pathology.med.umich.edu/point-of-care