FDA Authorization for InBios' ZIKV Detect 2.0 IgM Capture ELISA
InBios has received marketing authorization from the FDA for its ZIKV Detect 2.0 IgM Capture ELISA. The product is intended for the presumptive detection of Zika virus IgM antibodies in human sera collected from individuals who meet the criteria of the Centers for Disease Control and Prevention (CDC) for Zika virus clinical infection, which include a history of associated clinical symptoms or travel from a geographic location with active Zika transmission. This important diagnostic test kit contains all the necessary reagents and controls to perform the assay and obtain results in about four hours. Additional testing is required to confirm positive results from this assay.
The performance of the InBios Zika assay was evaluated by testing 807 unique specimens from 353 subjects at endemic sites and 256 subjects at non-endemic sites. In samples from patients collected 7 days or later after onset of symptoms, the InBios Zika kit correctly identified >90% of patients confirmed positive for Zika IgM and >96% of patients confirmed negative. In addition to identifying Zika-IgM positive patient samples, the assay differentiates Zika IgM from those infected with other flaviviruses (such as dengue or West Nile virus) which cross-react with Zika antibodies.
Dr. Raychaudhuri, CSO of InBios, said, “InBios has developed this important assay with grant funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Department of Health and Human Services. ZIKV Detect represents our most innovative product to date in our portfolio of flavivirus related products. We have several assays coming down the pipeline that will further improve detection of these complex arboviruses.”
Date Published: 4th June 2019
Source article link: InBios International Inc.