DIAGNOSTIC EFFICIENCY OF HOME PREGNANCY TEST KITS - A METAANALYSIS

Objective: To assess the diagnostic efficiency of home pregnancy test (HPT) kits. Data Sources: A literature search of English-language stud ies was performed with MEDLINE and a review of bibliographies. Study S election: Studies were included if HPT kits were compared with a crite rion 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 d isagreement was resolved by consensus. Sensitivity, specificity, and a n effectiveness score (a measure of the discriminatory power of the te st, with higher scores implying greater effectiveness) were calculated . Data Synthesist Five studies evaluating 16 HPT kits met the inclusio n criteria. The range of sensitivities for HPT kits was 0.52 to 1.0. I n studies where urine samples obtained by the investigators were teste d by volunteers, sensitivity was 0.91 (95% confidence interval [Cr], 0 .84-0.96). However, the sensitivity was less in studies where subjects were actual patients who performed the test on their own urine sample s (sensitivity, 0.75 [95% CI, 0.64-0.85]). The test effectiveness scor e was 2.75 (95% CI, 2.3-3.2) for studies where subjects were volunteer s but deteriorated to 0.82 (95% CI, 0.4-1.2) for studies with actual p atients. Conclusions: The diagnostic efficiency of HPT kits is greatly affected by characteristics of the users. Despite the popularity of t hese 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 market ing them to the general public.