August 2019—The U.S. Food and Drug Administration authorized marketing of a diagnostic test to detect Zika virus immunoglobulin antibodies in human blood. The ZIKV Detect 2.0 IgM Capture ELISA (InBios, Seattle) is the first Zika diagnostic test the FDA has allowed to be marketed in the U.S.; previously, tests for detecting Zika virus IgM antibodies, including the InBios test, had been authorized only for emergency use.
Read More »A new study, conducted by researchers at the John A. Burns School of Medicine, University of Hawaii, and published in the Journal of Microbiology, evaluated the InBios DENV Detect IgM capture ELISA for qualitative detection of IgM antibodies to dengue virus recombinant antigens. Well-characterized clinical serum samples collected from Hawaii, Vietnam, Niue, Singapore, and American Samoa were tested with the InBios ELISA in comparison with an in-house DENV IgM antibody capture (MAC) ELISA. The agreement, sensitivity, and specificity of the InBios assay were 94, 92, and 94 percent, respectively.
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CAP TODAY Pathology/Laboratory Medicine/Laboratory Management