Evaluation of a commercially available immunoglobulin M capture enzyme-linked immunosorbent assay kit for diagnosing acute dengue infections

Recently, commercially available kits for the detection of anti-dengue viru s (anti-DEN) immunoglobulin M (IgM) antibodies have been developed. These s tandardized assays have greatly enhanced our ability to effectively diagnos e DEN infections. We conducted an evaluation of a test kit manufactured by MRL Diagnostics Inc. that is designed to detect anti-DEN IgM antibodies. Ei ghty paired samples from DEN-infected individuals were tested by the MRL DE N Fever Virus IgM Capture enzyme-linked immunosorbent assay (ELISA), the Pa nBio Duo ELISA, the PanBio Rapid Immunochromatographic Test (PRIT), and the IgM-IgG antibody capture (MAC/GAC) ELISA, All infections were confirmed by either PCR-assisted detection of DEN transcripts or by DEN isolation in C6 /36 cells. Seventeen paired samples from individuals with no evidence of ac ute DEN infection were used as negative controls. The PRIT had the best sen sitivity (100%), whereas the MAC/GAC ELISA and the PanBio Due assay had the highest levels of specificity. The MRI, ELISA and the PanBio Duo assay wer e the top performers when taking into consideration both sensitivity and sp ecificity. All assays were able to detect DEN-specific antibodies in sample s from patients with either primary or secondary infections, regardless of the infecting DEN serotype.