Flowflex COVID-19 Antigen Home Test - 1 Test/Box (IDL031118B5)

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. FDA UPDATE: FDA has granted 510(k) clearance for Flowflex and becomes the first FDA 510(k) for an OTC rapid antigen Covid test! The 510(k) version of Flowflex will be produced domestically. OMICRON UPDATE: Does Flowflex Detect Omicron? An independent evaluation conducted by the National Institutes of Health’s (NIH) RADx program has indicated that the Flowflex™ COVID-19 Antigen Home Test does detect the Omicron subvariant BA.1 and BA.2 in live clinical samples. Clinical Performance: The performance of Flowflex COVID-19 Antigen Home Test was established in an all-comers clinical study conducted between March 2021 and May 2021 with 172 nasal swabs self-collected or pair-collected by another study participant from 108 individual symptomatic patients (within 7 days of onset) suspected of COVID-19 and 64 asymptomatic patients. The Flowflex COVID-19 Antigen Home Test results were compared to an FDA EUA RT-PCR COVID-19 assay to determine test performance in the table below: Flowflex COVID-19 Antigen Home Test RT-PCR method Positive Negative Total Positive 39 0 39 Negative 3 130 133 Total 42 130 172 Positive Percent Agreement (PPA) 93% (95% CI: 81% -99%) Negative Percent Agreement (NPA) 100% (95% CI: 97% – 100%) Analytical Sensitivity: Limit of Detection (LoD): LoD was determined as the lowest virus concentration that was detected ≥ 95% of the time. Based on this testing, the LoD in nasal matrix was confirmed to be 2.5 x 103 TCID50/mL PRODUCT DETAILS Catalog Number Description Units of Measurements IDL031118B5 Flowflex® COVID-19 Antigen Home Test  1 Test/Kit IDL031125M5 Flowflex® COVID-19 Antigen Home Test  2 Tests/Kit IDL031125P5 Flowflex® COVID-19 Antigen Home Test  25 Tests/Kit