Abstract
Anti–dengue virus immunoglobulin M kits were evaluated. Test sensitivities were 21%–99% and specificities were 77%–98% compared with reference ELISAs. False-positive results were found for patients with malaria or past dengue infections. Three ELISAs showing strong agreement with reference ELISAs will be included in the World Health Organization Bulk Procurement Scheme.
Highlights
Anti–dengue virus immunoglobulin M kits were evaluated
Laboratories at Mahidol University and CDC acted as reference laboratories by providing samples for proficiency testing among laboratories and for assembling and validating the evaluation panel
The evaluation panel consisted of 350 well-characterized serum specimens (Table 1)
Summary
Cuba), and Instituto Nacional Enfermedades Virales Humanas Dr Julio I. Laboratories at Mahidol University and CDC acted as reference laboratories by providing samples for proficiency testing among laboratories and for assembling and validating the evaluation panel. The evaluation panel consisted of 350 well-characterized serum specimens (Table 1). Specimens positive for IgM against DENV were obtained from patients with primary and secondary infections and represented all 4 DENV serotypes. IgM levels were determined by reference standard ELISAs used by CDC and the Armed Forces Research Institute of Medical Science (Bangkok, Thailand) [6,7]. Results were confirmed as negative for IgM antibodies against DENV by using predetermined reference standards. 20 anti-DENV IgM-negative specimens were obtained from SeraCare Diagnostics (Milford, MA, USA). Kappa coefficient values were determined to assess agreement of mean sensitivity and specificity of each test with the reference standard. A test of homogeneity was used to determine extent of agreement of results among sites
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