Home pregnancy tests in the hands of the intended user

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. Pa...

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Bibliographic Details
Published in:Journal of immunoassay & immunochemistry 2019-11, Vol.40 (6), p.642-652
Main Authors: Boxer, Jackie, Weddell, Sarah, Broomhead, David, Hogg, Cameron, Johnson, Sarah
Format: Article
Language:English
Subjects:
accuracy
Adult
Chorionic gonadotropin
Chorionic Gonadotropin - urine
Clinical trials
Component reliability
Europe
Female
Gonadotropins
Home medical tests
Home pregnancy tests
human chorionic gonadotropin
Humans
in vitro diagnostic device regulation
Middle Aged
Performance evaluation
Pituitary (anterior)
Pregnancy
Pregnancy Tests
Reproducibility of Results
sensitivity
Standardization
Urine
Usability
validation testing
Young Adult
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Summary: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
ISSN:1532-1819
1532-4230
DOI:10.1080/15321819.2019.1671861