The Coronavirus Ag Rapid Test Cassette (Swab) is an immunochromatographic membrane assay that uses highly sensitive monoclonal antibodies to detect nucleocapsid protein from SARS-CoV-2 in nasopharyngeal (NP) swab. The test strip is composed of the following parts: namely sample pad, reagent pad, reaction membrane, and absorbing pad. The reagent pad contains the colloidal-gold conjugated with the monoclonal antibodies against the nucleocapsid protein of SARS-CoV-2; the reaction membrane contains the secondary antibodies for nucleocapsid protein of SARS-CoV-2.
This test is for detection of SARS-CoV-2 nucleocapsid protein antigen. Antigen is generally detectable in upper respiratory specimens during the acute phase of infection. Rapid diagnosis of SARS-CoV-2 infection will help healthcare professionals to treat patients and control the disease more efficiently and effectively.
FDA Acknowledgment Letter: FDA Letter
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Warning : This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory's CLIA certificate of high-complexity testing.
This test is not for home-use or at-home specimen collection.
The Coronavirus Ag Antigen Test Kit Cassette (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasopharyngeal (NP) swab specimens directly or after the swabs have been added to viral transport media from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Coronavirus Ag Antigen Test Kit Cassette (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
Serology Test Evaluation Report