Intended Use:
The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay intended
for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in
direct anterior nasal swab specimens collected from individuals who are suspected
of COVID-19 by their healthcare provider within the first five (5) days of symptoms
onset when tested at least twice over three days with at least 48 hours between
tests or from individuals without symptoms or other epidemiological reasons to
suspect COVID-19 when tested at least three times over five days with at least 48
hours between tests. Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the
requirements to perform moderate, high or waived complexity tests. This product is
authorized for use at the Point of Care (POC), i.e., in patient care settings operating
under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of
Accreditation.
