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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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1
SPD Development Co., Ltd , Priory Business Park, Bedford, MK44 3UP, UK.

Abstract

BACKGROUND:

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.

OBJECTIVES:

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

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

PMID:
23957730
DOI:
10.1517/17530059.2013.830103
[Indexed for MEDLINE]

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