Flowflex Plus Covid -19 and Flu A/B Home Test - 1 Count

Description

The Flowflex Plus COVID-19 and Flu A/B Home 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 nares 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 six (6) 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. The Flowflex Plus COVID-19 and Flu A/B Home Test does not differentiate between SARS-CoV and SARS-CoV-2 viruses and is not intended to detect influenza C antigens. All negative SARS-CoV-2 results are presumptive. Clinical Performance: The Flowflex Plus COVID-19 and Flu A/B Home Test was compared to FDA EUA and 510(k) RT-PCR COVID-19 and Flu A/B assays. The Flowflex Plus COVID-19 and Flu A/B Home Test correctly identified 90.6% of positive specimens and 99.3% of negative specimens for COVID-19, 91.7% of positive specimens and 99.8% of negative specimens for Flu A, and 93.6% of positive specimens and 99.7% of negative specimens for Flu B.

Directions

Read the instructions fully and carefully before performing the test. Failure to follow the instructions may result in inaccurate test results. This test may only be used in symptomatic individuals.

Ingredients

1 Test Casette, 1 Extraction Buffer Tube, 1 Disposable Nasal Swab, 1 Tube Holder, Quick Reference Instructions.

WARNINGS

Keep out of reach of children. Read the Flowflex Plus COVID-19 and Flu A/B Home Test Package Insert carefully before performing a test. Failure to follow directions may produce inaccurate test results. • The Test is intended to aid in the diagnosis of a current COVID-19 and/or Flu A/B infection. Please consult a healthcare professional to discuss your results and if any additional testing is required. • Keep test kit and materials out of the reach of children and pets before and after use. • Do not use on anyone under two years of age. • Do not open the kit contents until ready for use. If the test cassette is open for an hour or longer, invalid test results may occur. • Do not use the test after the expiration date shown on the test cassette pouch. • Do not use the test if the pouch is damaged or open. • Do not reuse any kit components. Do not use with multiple specimens. • Make sure there is sufficient light when testing. • Do not use nasal sprays for at least 30 minutes before collecting a nasal sample. This product has not been FDA cleared or approved but has been authorized by FDA under an EUA.