This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, 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.
- The FlowFlex™ COVID-19 Antigen Home Test is a lateral flow immunochromatographic assay for the detection of extracted nucleocapsid protein antigens specific to SARS-CoV-2, not for any other viruses or pathogens.
- For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures
- Detect SARS-CoV-2 nucleocapsid protein antigen
- Nasal Swab: 98.8% (95% CI: 97.6%-99.5%) 95% Confidence Intervals
- Saliva: 97.1% (95% CI: 94.6%-98.5%) 95% Confidence Intervals
- Variant-ready solution
- Instructions for Use at Home HERE
- Healthcare Provider Instructions for Use HERE
- Rapid results within 15 minutes
- Expiration Date: If you receive a box that has an expiration date that has past, please do not be concerned. The state department has granted an extended expiration life FOR THIS PRODUCT. Please see extension letter EUA-ACONlab-flowflexAg-Rev-2022-04-20 .