POSITIVE: If a Control (C) line and the Test ( T) line are visible, the test is positive. Any faint visible red test (T) with the control line (C) should be read as positive.
NEGATIVE: If the Control (C) line is visible, but the test line is not visible, the test is negative.
INVALID: No red-colored line next to the “C” means the test is invalid. Re-test with a new swab and new test device. ( if there is no red line next to the “C”, the result is invalid regardless of whether there is a red-colored line next to the “T”.
In the USA, the INDICAID® COVID-19 RAPID ANTIGEN TEST has not been FDA cleared or approved, but has been authorized by FDA under an Emergency Use Authorization. This product has been authorized only for the detection of proteins from SARS-Cov-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner.