Home pregnancy tests in the hands of the intended user

Abstract

ABSTRACT The 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