Diagnostics Evaluation Series No. 3
Evaluation of commercially available anti-dengue virus immunoglobulin M tests
Dengue infection can produce a broad spectrum of symptoms and range from mild febrile illness to severe disease. Clinical features are often nonspecific and therefore require laboratory confirmation. Accurate but sophisticated methods like virus isolation or polymerase chain reaction (PCR) require advanced equipment and infrastructure.
Serological assays that can detect specific immunoglobulin M (IgM) or immunoglobulin G (IgG) antibodies to dengue virus (DENV) are widely available. These assays can provide an alternative to virus isolation or PCR to support the diagnosis of dengue fever. First-time (primary) DENV infections typically have a stronger and more specific IgM response; subsequent (secondary) infections show a weaker IgM response but a strong IgG response. These differing IgM response patterns to infection underscore the need to evaluate the sensitivity and specificity of commercially available tests, especially for diagnosis of secondary DENV infections.
WHO/TDR and the Pediatric Dengue Vaccine Initiative collaborated to evaluate commercially available anti-DENV IgM diagnostic tests. A network of seven laboratories in Asia and Latin America was established to carry out the work. This report describes the results of an evaluation of nine commercially available anti-DENV IgM tests, using a panel of well-characterized, archived serum specimens from patients with confirmed DENV infections and from patients with other potentially confounding infections and conditions.