Instructions for Use (IFU)CLINITEST® Rapid COVID-19 Antigen Self-Test

All CLINITEST® Rapid COVID-19 Antigen Self-Tests distributed in the U.S. have expired and should not be used. Because these products have expired, we are no longer providing phone support.


Clinical Use

Download Instructions for Use

Steps to use the test, FAQs, and safety information. 


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In the USA, this product 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-19 under 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.