Performance of qualitative urinary hCG assays.

Abstract

Significant differences in the sensitivity of eight frequently used qualitative urine human chorionic gonadotropin (hCG) tests in Belgium were observed in this study. Although most manufacturers claimed to detect hCG levels as low as 25 mIU/ml, only two out of six tests for home use and one out of two tests for professional use only, achieved the claimed detection limit. According to a survey, we performed among 20 acute care hospitals, 80% of the surveyed hospitals claimed to use these types of hCG analysis in a diagnostic setting. Unsatisfactory performance of these point-of-care testing (POC) assays for urinary hCG could have major consequences in a hospital setting, exposing the early pregnant woman to harmful diagnostic and therapeutic procedures. Although qualitative urine hCG tests are rapid and convenient, determination of hCG in blood remains the gold standard for the diagnosis of pregnancy.