The comparative accuracy of 8 commercial rapid immunochromatographic assays for the diagnosis of acute dengue virus infection.

Journal article

BACKGROUND: The serological diagnosis of acute dengue virus infection relies on the detection of dengue-specific immunoglobulin M (IgM) antibodies. Immunochromatographic tests are rapid diagnostic tests (RDTs) that can be performed at the bedside, but they have not been fully validated for diagnosis of dengue infection. METHODS: More than 20 RDTs for diagnosis of acute dengue infection are commercially available. Of these, 8 were selected for evaluation of performance by use of characterized dengue and nondengue serum specimens, and results were compared with those of a previously published dengue IgM/IgG enzyme-linked immunosorbent assay in conjunction with dengue virus serotyping by reverse-transcriptase polymerase chain reaction. RESULTS: Assay sensitivities were low, ranging from 6.4% (95% confidence interval [CI], 4.0%-9.7%) to 65.3% (95% CI, 59.9%-70.5%), and specificities ranged from 69.1% (95% CI, 61.4%-76.0%) to 100% (95% CI, 97.8%-100%). Of the 8 tests, only 2 had sensitivities of >50%, the level considered to be clinically useful, and, of these, 1 had relatively low specificity (69.1%). Samples collected early in the infection were less likely to test positive than those collected later. A thermal stability study demonstrated a loss in performance of some RDTs when they were stored at a high ambient temperature for 3 months. CONCLUSIONS: Users of RDTs for dengue should be aware that many of these tests have a diagnostic accuracy that falls well below the manufacturers' claims. If an acute specimen yields a negative result, a convalescent serum sample should be tested to confirm the result. No RDT adequately differentiated primary and secondary dengue infections, and the tests should not be used for this purpose.

Authors: Blacksell, S; Newton, P; Bell, D; Kelley, J; Mammen, M

• Publication status: Published
• Journal: Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
• Volume: 42
• Issue: 8
• Pages: 1127-1134
• Publication date: 2006-04-01
• DOI: 10.1086/501358
• EISSN: 1537-6591
• ISSN: 1058-4838
• Language: English
• Keywords: Sensitivity and Specificity; Antibodies, Viral; Great Britain; Acute Disease; Enzyme-Linked Immunosorbent Assay; Software; Dengue Virus; Dengue; Reproducibility of Results; Humans; Reverse Transcriptase Polymerase Chain Reaction