DEVICE: Vivera Advanced Diagnostics COVx-RDA SARS-CoV-2 Antigen Test.
SENSITIVITY OF ANTIGEN IMMUNOASSAY: 98.2%
SPECIFICITY OF ANTIGEN IMMUNOASSAY: 99%
TEST PROCEDURE: The Vivera COVx-RDA Antigen Test may be performed with a nasal specimen placed on the cassette. Results are read at 10 minutes. The full test procedure is outlined in the Instructions For Use included in each kit.
SPECIFICATIONS: The Vivera Advanced Diagnostics COVx-RDA SARS-CoV-2 Antigen Test is a lateral flow immunoassay intended for rapid, qualitative detection of the SARS-CoV-2 nucleocapsid protein in nasal specimens. The tests are easy to use with clear result indication at 10 minutes, allowing for efficient on site testing by healthcare professionals at CLIA certified facilities for high complexity testing.
