FlowFlex PLUS OTC 4-in-1 RSV + Covid-19 + Flu A&B Antigen Test (1test/Box)

Description

The Flowflex Plus RSV + Flu A/B + COVID Home Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of respiratory syncytial virus (RSV), influenza A, influenza B, and SARS-CoV-2 protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to RSV, influenza, and SARS-CoV-2 can be similar. This test is for non-prescription home use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older. All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with RSV, influenza, SARS-CoV-2 or other pathogens. Individuals who test negative and/or experience continued or worsening symptoms, such as fever, cough and/or shortness of breath should therefore seek follow-up care from their healthcare provider.

• Results in 15 minutes

• 24 months shelf life

• Store between 36 to 86 F

• Small sized packaging makes for easy travel and storage

• Self-collected anterior nasal swab specimens from individuals aged 14 years

or older

• Sample collection by an adult for children ages 2 to 13

• Sample collection by 2 adults with swab guard for children 6 to 23 months

• Excellent performance when compared to highly sensitive PCR tests

Clinical Performance

The Flowflex Plus RSV + Flu A/B + COVID Home Test was compared to highly sensitive PCR tests. The Flowflex Plus RSV + Flu A/B + COVID Home Test correctly identified 91.6% of positive specimens and 99.9% of negative specimens of COVID-19, 92.9% of positive specimens and 99.8% of negative specimens of Flu A, 92.9% of positive specimens and 99.9% of negative specimens of Flu B, and 94.1% of positive specimens and 99.8% of negative specimens of RSV.