Rapid COVID-19 Antigen Test (Swab) is an in vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of Covid-19 by their healthcare provider.
o Positive Percent Agreement (PPA): 95.7%
o Negative Percent Agreement (NPA): 99.6%
o Overall Percent Agreement (OPA): 98.9%
20 tests per box
Call or email for pricing; volume pricing available
Within the US: 800-227-1243
Outside the US: 518-758-8158
The test has not been reviewed by the FDA.
Negative results do not rule out a 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 the product 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.
The test is not for home use or at-home specimen collection.