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Expert Opin Med Diagn. 2013 Sep;7(5):435-41. doi: 10.1517/17530059.2013.830103. Epub 2013 Aug 19.

Comparison of volunteers' experience of using, and accuracy of reading, different types of home pregnancy test formats.

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SPD Development Co., Ltd , Priory Business Park, Bedford, MK44 3UP, UK.



Women suspecting pregnancy need an accurate result when they conduct a home pregnancy test. A variety of tests are available from simple professional style strips to midstream tests with a digitally displayed result. However, it is not known whether all these formats can be used and read correctly by untrained women.


The aim of this study is to evaluate usability and reading accuracy of home pregnancy test formats.


Female volunteers, 18 - 45 years (Manchester, UK) completed questionnaires on their home-use experience of six pregnancy tests (strip, cassette, midstream visual and digital formats). These volunteers then evaluated device results using hCG-urine standards at a study centre, thereafter completing a questionnaire and ranking evaluation.


Data were available from 111 volunteers. Women preferred midstream test formats; > 70% scored branded midstream digital and easy-use visual tests as 1or 2 (7-point Likert score), compared with ∼ 30% for store-brand and branded midstream visual tests, and < 10% for cassette or strip tests. Many cassette tests (23%) failed to provide a result (4, ≤ 2% for strips, midstream, respectively). Volunteers disagreed with study co-ordinator reading of test results in 30 and 40% of cases for the cassette and strip test results, respectively, compared with < 3% when using midstream digital or easy-use visual tests. Volunteers preferred the branded midstream digital, followed by branded midstream easy-use and visual tests.


In this study, the branded midstream digital test was superior to other tests evaluated and fulfilled the criteria of being an easy-to-use and interpret test; strip and cassette tests showed poor performance in women's hands.

[Indexed for MEDLINE]

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