Download The Flowflex Evaluation Report Here.pdf

The Flowflex SARS-CoV-2 Antigen Rapid Test is a lateral flow chromatographic immunoassay for detecting the nucleocapsid protein antigen from SARS-CoV-2 in nasal and nasopharyngeal swab specimens. The test is intended for use by trained clinical laboratory personnel and individuals in point-of-care settings. It does not differentiate between SARS-CoV and SARS-CoV-2. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions.

The test's performance was evaluated through an imprecision/reproducibility study, a limit of detection (LOD) study, and a clinical study. The imprecision/reproducibility study found that all three lots of the test identified samples 100% correctly as negative or positive. The LOD study determined that the minimum detectability of the test is 1.6 x 10^2 TCID50/mL for both nasal and nasopharyngeal swab specimens. A multi-site clinical study was conducted to evaluate the test's performance, with results showing its effectiveness in detecting SARS-CoV-2 antigens in clinical samples.