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Home pregnancy tests reviewed

A characteristic of modern life is the availability of pregnancy testing kits bought from pharmacies and elsewhere to allow women to confirm or exclude that they are pregnant. How reliable are they? A review of studies [1] suggests that all is not as simple as it seems, and that they need to be looked at with a cold and fishy eye.


A thorough search strategy identified 55 studies, of which 45 were immediately excluded because they were reviews or because the kit examined was not compared with a reliable laboratory standard. Of the remaining 10, five more were excluded because studies had no control groups of non-pregnant patients, sensitivity and specificity could not be calculated from data given, the kit demonstrated poor performance or was not available, or because the study was small. In this latter category was the report which tested kits on three (yes, 3) subjects.


That left five reasonable studies.


Home pregnancy testing kits usually claim accuracy of over 95% (whatever that may mean). The reality is that the literature contains information on only four kits evaluated as they are intended to be used - by women testing their own urine. The results we have suggest that for every four women who use such a test and are pregnant, one will get a negative test result. It also suggests that for every four women who are not pregnant, one will have a positive test result.

Many important decisions will hinge on the results of a home pregnancy test - whether to see a doctor, decisions about termination, decisions about relationships. In the circumstances, the paucity and quality of published information could be regarded as a scandal. While results in the hands of experienced technicians may be adequate, it is clear that in the situation in which they are intended to be used, the tests do not work well enough. Women should know this.


  1. LA Bastian et al. Diagnostic efficiency of home pregnancy kits. Archives of Family Medicine 1998 7: 465-469.
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