Sorrento announces Emergency Use Authorization application to the FDA for COVI-STIX Rapid Test for the Detection of SARS-CoV-2 viral antigen

Sorrento Therapeutics, Inc. announced that an Emergency Use Authorization (EUA) Application has been submitted to the FDA for its COVI-STIX rapid diagnostic test for the detection of the SARS-CoV-2 virus nucleocapsid antigen in nasal samples of patients. In testing conducted to date, COVI-STIX has provided results within 15 minutes, with positive detection as quickly as two minutes for patient samples with high viral load. COVI-STIX has been developed by Sorrento as a highly sensitive and accurate lateral flow immunoassay for rapid SARS-CoV-2 antigen detection. COVI-STIX is a highly sensitive assay that detects single SARS-CoV-2 virus antigens directly from a shallow nasal swab (nasal, not nasopharyngeal) sample in 15 – 20 minutes. COVI-STIX uses a simple one-step protocol that only requires mixing the sample with a buffer and applying the sample to the COVI-STIX test well. Simple capillary action will drive the sample through the cassette and displays an obvious black line if the viral antigen is detected. This technology is ideally suited (when cleared for use) for rapid laboratory, point-of-care testing or at-home use.