Objectives: Owing to difficulties in the clinical diagnosis of leprosy, several complementary tests have been developed and used. The aim was to systematically summarize the accuracy of diagnostic tests for leprosy. Methods: We searched for relevant articles in Embase, Medline, and Global Health databases, until June 2017. Studies evaluating the accuracy of any diagnostic techniques for differentiating between people with and without leprosy were included. Studies solely focusing on differentiating between the separate forms of leprosy were excluded. Our protocol was registered on PROSPERO (CRD42017071803). We assessed study quality using the QUADAS-2 checklist. A bivariate random effects regression model was used for the meta-analyses. Results: We included 78 studies, most of those evaluating the detection of IgM antibodies against phenolic glycolipid I using ELISA. Sensitivity of the 39 studies evaluating ELISA was 63.8% (95% CI 55.0 e71.8); specificity 91.0% (95% CI 86.9e93.9). The lateral flow test (nine studies) and the agglutination test (five studies) had a slightly higher sensitivity and a slightly lower specificity. Sensitivity of qPCR was (five studies) 78.5% (95% CI 61.9e89.2) and specificity 89.3% (95% CI 61.4e97.8). Sensitivity of conventional PCR was (17 studies) 75.3% (95% CI 67.9e81.5) and specificity 94.5% (95% CI 91.4e96.5). Conclusions: Although the test accuracy looks reasonable, the studies suffered from heterogeneity and low methodological quality.
Objectives: Embase is a biomedical and pharmacological bibliographic database of published literature, produced by Elsevier. In 2011, Embase introduced the Emtree term ''diagnostic test accuracy study,'' after discussion with the diagnostic test accuracy (DTA) community of Cochrane. The aim of this study is to investigate the performance of this Emtree term when used to retrieve diagnostic accuracy studies.Study Design and Setting: We first piloted a random selection of 1,000 titles from Embase and then repeated the process with 1,223 studies specifically limited to humans. Two researchers independently screened those for eligibility. From titles that were indicated as being relevant or potentially relevant by at least one assessor, the full texts were retrieved and screened. A third researcher retrieved the Emtree terms for each title and checked whether ''diagnostic test accuracy study'' was one of the attached Emtree terms. The results of both exercises were then cross-classified, and sensitivity and specificity of the Emtree term were estimated.Results: Our pilot set consisted of 1,000 studies, of which 20 (2.0%) were studies from which DTA data could be extracted. Thirteen studies had the label DTA study, of which five were indeed DTA studies. The final set consisted of 1,223 studies, of which 33 (2.7%) were DTA studies. Twenty studies were labeled as DTA study, of which fourteen indeed were DTA studies. This resulted in a sensitivity of 42.4% (95% CI: 25.5% to 60.8%) and a specificity of 99.5% (95% CI: 98.9% to 99.8%).Conclusion: Although we planned to include a more focused set of studies in our second attempt, the percentage of DTA studies was similar in both attempts. The DTA label failed to retrieve most of the DTA studies and 30% of the studies labeled as being DTA study were in fact not DTA studies. The Emtree term DTA study does not meet the requirements to be useful for retrieving DTA studies accurately.
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