Reproductive-endocrine point-of-care testing: current status and limitations

Point-of-care (POC) testing for the detection of pregnancy and the prediction of ovulation has grown and evolved since the introduction of the first qualitative pregnancy test marketed directly to the consumer over three decades ago. Numerous publications have analyzed both pregnancy and ovulation prediction devices for their sensitivity, accuracy and general utility. Despite vast improvements in ease-of-use and sensitivity from their earlier forms, the primary literature regarding the utility of these devices is at times incomplete. This article reviews the literature focusing on the sensitivity and accuracy of the modern urine-luteinizing hormone ovulation prediction devices, and the effect these devices have on fertility rates. In addition, the analytical sensitivity and clinical utility of POC pregnancy tests will be reviewed, along with the potential causes of false negative and false positive results. Clin Chem Lab Med 2010;48:935–42.