OTC SpeedySwab™ Rapid COVID-19 + FLU A&B Antigen Self-Test 1 Test Kit/Box (500 Box/Carton)

The SpeedySwab Rapid COVID-19 + Flu A&B Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of SARS-CoV-2, influenza A, and influenza B protein antigens.

This test is authorized for non-prescription home use with self-collected anterior nasal swab specimens from individuals aged 14 years or older, or with adult-collected anterior nasal swab specimens from individuals two (2) years or older. This test is only authorized for individuals with signs and symptoms of respiratory infection consistent with COVID-19 within the first five (5) days of symptom onset when tested at least twice over three days with at least 48 hours between tests.

Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar.

Results are for the simultaneous identification of SARS-CoV-2, influenza A virus, and influenza B virus protein antigens, but do not differentiate between SARS-CoV and SARS-CoV-2 viruses and are not intended to detect influenza C antigens.

The viral antigens targeted by this test are generally detectable from specimens collected using nasal swabs during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status.

Test type: Lateral flow assay
Specimen type: Anterior nasal swab specimens
Turnaround time: 15 minutes
CLIA complexity: OTC
FDA status: Emergency Use Authorization (EUA)
Shelf Life: 18 months from the Date of Manufacture (DOM). Allows for use across multiple respiratory seasons, providing extended product utility and flexibility

• 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, influenza A and influenza B, 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.