Abstract
ABSTRACTThe objectives of this study were to investigate the usability and performance of seven visual home pregnancy tests, available in Europe. Part one of the study was home-based and involved volunteers testing a selection of four home pregnancy tests. The tests used and order of use were randomized. Part two, performed at a study site, involved volunteers reading and interpreting the results of the same selection of home pregnancy tests used in part one, but using urine standards representing early pregnancy (25 mIU/mL human chorionic gonadotropin) or a ‘not pregnant’ (0 mIU/mL human chorionic gonadotropin) sample. The volunteers completed a questionnaire after each test in both parts. Three of the seven tests met their accuracy/reliability claims: tests A (99.8%), B (100%), and F (97.6%) (not statistically different from the claimed 99% accuracy). The remaining four tests had accuracies/reliabilities of <99% at 81.6% (C), 89.0% (E), 92.5% (D), and 95.9% (G), respectively. Test A was the highest-rated test for each attribute tested in both settings. Test D was ranked the lowest in part one and test C was ranked lowest overall for part two. Home pregnancy tests vary in performance and usability, therefore requiring better standardization and performance evaluation in Europe.Clinical Trials Reference Number: NCT03589534
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