Evaluation of a New Commercially Available Immunoglobulin M Capture Enzyme-Linked Immunosorbent Assay for Diagnosis of Dengue Virus Infection

Abstract

dWe evaluated the FDA-cleared InBios dengue virus (DENV) IgM capture enzyme-linked immunosorbent assay (ELISA) for qualitative detection of anti-DENV IgM antibodies from 79 serum samples obtained from dengue virus-infected patients or suspected dengue cases. The agreement, sensitivity, and specificity of the InBios assay compared to the gold standard in-house DENV IgM capture ELISA were 94, 92, and 94%, respectively. We conclude that the InBios DENV IgM capture ELISA can be effectively used for rapid diagnosis of acute or recent DENV infection. Dengue virus (DENV) a mosquito-borne flavivirus, is a significant human pathogen of global importance (1). Dengue, an acute viral disease, is caused by any one of the four DENV serotypes, DENV-1, -2, -3, and -4 (2). Although most of the reported dengue cases in the United States are acquired by travelers or immigrants (3), autochthonous dengue fever outbreaks have occurred in Brownsville, TX (2005), and southern Florida (2009 to 2011) and Hawaii (2011) (4). To date, there is no vaccine or specific antiviral treatment for dengue virus infection in humans, and effective management of severe dengue virus disease can be augmented by rapid diagnosis during the acute stage of infection (5, 6).In the majority of DENV infections, immunoglobulin M (IgM) antibodies can be detected within 3 to 5 days following the onset of fever (7). In secondary DENV infection, IgM antibody titers are usually lower than those in primary DENV infection but follow similar kinetics (8). An ideal IgM serologic test should have sufficient sensitivity to detect low DENV IgM antibody titers and be specific enough to discriminate DENV infection in areas where multiple flaviviruses and other pathogens cocirculate (9). Several rapid diagnostic tests are commercially available for detection of anti-DENV IgM antibodies (9). Therefore, it is important to evaluate the performance characteristics of these kits in terms of sensitivity and specificity in order to ensure accurate and rapid diagnosis of dengue virus infection (5). Recently, the U.S. Food and Drug Administration (FDA) cleared the InBios DENV Detect IgM capture enzyme-linked immunosorbent assay (ELISA) (InBios International, Inc., Seattle, WA) for qualitative detection of anti-DENV IgM antibodies (4). This test can detect acute or recent DENV infections and can be used by public health laboratories for rapid confirmation of dengue cases during dengue outbreaks (4).(These research data are part of the master's thesis of M.N. submitted to the University of Hawaii.)In this study, we evaluated the InBios DENV IgM capture ELISA in comparison with the in-house DENV IgM antibody capture (MAC) ELISA using 79 well-characterized clinical serum samples collected from Hawaii, Vietnam, Niue, Singapore, and American Samoa, where dengue outbreaks have occurred in the past. Samples were coded and collected in compliance with the University of Hawaii Institutional Review Board guidelines (CHS 16857 and 16873). All serum samples were frozen at Ϫ70°C prior to assay.The I...

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