Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

Sorrento Submits EUA to the US FDA for its COVI-TRACK Test to Detect COVID-19

Shots:

  • Sorrento has reported that its EUA is under review at the US FDA for its COVI-TRACK in vitro diagnostic test kit for the detection of IgG and IgM Abs in sera of patients exposed to the SARS-CoV-2 virus
  • Following the issuance of an EUA, the COVI-TRACK test will be available for distribution to clinical testing sites nationwide. The assay develops three clear lines that confirm the assay validity and the qualitative detection & differentiation of IgM and IgG Abs to the COVID-19
  • Sorrento has secured manufacturing capacity to ramp up the production of up to 5M test kits/ month with the availability of results in ≤8mins. The assay showed specificity > 97% and diagnostic sensitivity of > 94% in an analytical validation

Click here to read full press release/ article | Ref: Sorrento | Image: Pharmaworld

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