OBJECTIVE: To evaluate the quality and accuracy of serological diagnosis of canine visceral leishmaniasis in the Americas. METHODS: A systematic review found original studies in the databases MEDLINE, EMBASE and LILACS up to November 2012 and in complementary sources up to February 2013. Studies were evaluated in accordance with QUADAS 2 and STARD parameters and recommended in accordance with GRADE parameters. Meta-analysis was carried out with Meta-DiSc software, using the random-effect model. RESULTS: Two hundred and eighty-four studies were identified, of which 25 met the inclusion criteria, comprising the final synthesis. All but one was conducted in Brazil, and only two were judged to be of good quality. 15 studies involving immuno-enzymatic tests with crude antigens (cELISA), 11 studies on indirect immunofluorescence tests (IFAT) and three on the immunochromatographic dual-path platform (DPP) test were meta-analysed. The combined results for sensitivity and specificity were cELISA: 0.89 (CI 95% 0.87-0.91) and 0.87 (CI 95% 0.86-0.88); IFAT: 0.88 (CI 95% 0.85-0.91) and 0.63 (CI 95% 0.61-0.65); and DPP: 0.83 (CI 95% 0.78-0.88) and 0.73 (CI 95% 0.70-0.75). CONCLUSION: Enzyme-linked immunosorbent assay with crude antigens and DPP tests have moderate accuracy for the diagnosis of canine visceral leishmaniasis, and the quality of the design, implementation and analysis of validation studies on diagnostic tests for this disease urgently require improvement. The recommendation for use of the evaluated tests is based on evidence that is scarce and restricted to Brazil.
OBJECTIVE: To evaluate the quality and accuracy of serological diagnosis of caninevisceral leishmaniasis in the Americas. METHODS: A systematic review found original studies in the databases MEDLINE, EMBASE and LILACS up to November 2012 and in complementary sources up to February 2013. Studies were evaluated in accordance with QUADAS 2 and STARD parameters and recommended in accordance with GRADE parameters. Meta-analysis was carried out with Meta-DiSc software, using the random-effect model. RESULTS: Two hundred and eighty-four studies were identified, of which 25 met the inclusion criteria, comprising the final synthesis. All but one was conducted in Brazil, and only two were judged to be of good quality. 15 studies involving immuno-enzymatic tests with crude antigens (cELISA), 11 studies on indirect immunofluorescence tests (IFAT) and three on the immunochromatographic dual-path platform (DPP) test were meta-analysed. The combined results for sensitivity and specificity were cELISA: 0.89 (CI 95% 0.87-0.91) and 0.87 (CI 95% 0.86-0.88); IFAT: 0.88 (CI 95% 0.85-0.91) and 0.63 (CI 95% 0.61-0.65); and DPP: 0.83 (CI 95% 0.78-0.88) and 0.73 (CI 95% 0.70-0.75). CONCLUSION: Enzyme-linked immunosorbent assay with crude antigens and DPP tests have moderate accuracy for the diagnosis of caninevisceral leishmaniasis, and the quality of the design, implementation and analysis of validation studies on diagnostic tests for this disease urgently require improvement. The recommendation for use of the evaluated tests is based on evidence that is scarce and restricted to Brazil.
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