Objective: To assess the diagnostic efficiency of home pregnancy test (HPT) kits.
Data sources: A literature search of English-language studies was performed with MEDLINE and a review of bibliographies.
Study selection: Studies were included if HPT kits were compared with a criterion standard (laboratory testing), if they used appropriate controls, and if data were available to determine sensitivity and specificity.
Data extraction: Two investigators independently extracted data, and disagreement was resolved by consensus. Sensitivity, specificity, and an effectiveness score (a measure of the discriminatory power of the test, with higher scores implying greater effectiveness) were calculated.
Data synthesis: Five studies evaluating 16 HPT kits met the inclusion criteria. The range of sensitivities for HPT kits was 0.52 to 1.0. In studies where urine samples obtained by the investigators were tested by volunteers, sensitivity was 0.91 (95% confidence interval [CI], 0.84-0.96). However, the sensitivity was less in studies where subjects were actual patients who performed the test on their own urine samples (sensitivity, 0.75 [95% CI, 0.64-0.85]). The test effectiveness score was 2.75 (95% CI, 2.3-3.2) for studies where subjects were volunteers but deteriorated to 0.82 (95% CI, 0.4-1.2) for studies with actual patients.
Conclusions: The diagnostic efficiency of HPT kits is greatly affected by characteristics of the users. Despite the popularity of these kits, the relatively low effectiveness scores of these kits when used by actual patients are of concern. We suggest that manufacturers of HPT kits publish results of trials in actual patients before marketing them to the general public.