Description
Contents: Individually wrapped sterile foam swab, Test Strip, Pre-filled Buffer Tube, Package Insert
Regulatory Status: FDA Emergency Use Authorization, OTC
Determinations: Detection of COVID-19 (SARS-CoV-2)
Processing Time: 15 Minutes
Flowflex COVID-19 Antigen Home Test is a rapid test for the detection of SARS-CoV-2 antigens in anterior nasal specimens directly from individuals within 7 days of symptom onset or without symptoms or other epidemiological reasons to suspect COVID-19 infection. For self-testing use. For use under an Emergency Use Authorization (EUA) only.
This test is authorized for non-prescription home use with self collected anterior nasal swab specimens directly from individuals aged 14 years and older or with adult-collected anterior nasal samples directly from individuals aged 2 years or older. The Flowflex COVID-19 Antigen Home Test does not differentiate between SARSCoV and SARS-CoV-2.
Features
- Cassette Format
- Positive Percent Agreement (PPA): 93% (95% Cl: 81%-99%)
- Negative Percent Agreement (NPA): 100% (95% Cl: 97%-100%)
- Analytical Sensitivity: Limit of Detection (LoD): 2.5 x 103 TCID50/m
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