POC SpeedySwab™ Rapid COVID-19 + FLU A&B Antigen Test (25 Test Kits/Box)
Regulatory Status: FDA EUA Authorized – this test has not been FDA cleared or approved but has been authorized by the FDA under an EUA for use by authorized laboratories.
Contents: Each box contains: Test Devices (25), Buffer solution (25), Nasal swabs (25), Quick Reference Instructions (QRI) (1)
Determinations: Detection of the SARS-CoV-2 nucleocapsid protein antigen and Influenza A&B
Storage Requirements: 15° – 30° C
Processing Time: 15 Minutes
SpeedySwab Features:
-
Quick: With SpeedySwab, users can expect quick results in just 15 minutes.
-
Easy: User-friendly testing with easy-to-follow instructions.
-
Reliable: With a COVID-19 clinical sensitivity of 92.6%, Flu A clinical sensitivity of 82.9% and Flu B clinical sensitivity of 90%, this combo test allows users to accurately differentiate between COVID-19, Flu A, and Flu B.
-
Shelf Life: 18 months from the Date of Manufacture (DOM). Allows for use across multiple respiratory seasons, providing extended product utility and flexibility
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 SARSCoV-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
