Description The Flowflex SARS-CoV-2 Antigen Rapid Lateral FlowTest is a lateral flow chromatographic immunoassay for the qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in nasal swab specimens directly from individuals who are suspected of an active COVID-19 infection by their healthcare provider within the first seven days of the onset of symptoms. Supplied in a single pack Cassette Format Detects the nucleocapsid protein antigen from SARS-CoV-2 Nasal Specimen sample. Anterior Nares Only Test (2-4cm inside the nostril) Results in 15 minutes CE Marked for Self Test Used by NHS track and trace as a home test Unique ID QR code number on each cassette Pack Contents 1 x Test Cassette with QR code and unique ID number 1 x Extraction Buffer Tube 1 x Disposable Swab 1 x Waste Bag 1 x Package Insert Features: Warnings This product has not been FDA cleared or approved but has been authorized by FDA under an EUA. This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of IVDs for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated, or authorization is revoked sooner. Fully Home Use Approved Validation from Public Health England Porton Down. Full Home Test Approval Granted in the UK & EU Registered with MHRA and CE Marked. Used and trusted by companies around the world including all UK airports and the NHS. Detailed Technical Information - Feature Specification Test FormatCassette Specimen FormatNasal Swab DetectsThe nucleocapsid protein antigen from SARS-CoV-2Sample Volume4 to 5 drops of the prepared specimen Relative Sensitivity 97.1% (83.8%-99.9%) 95% Confidence IntervalsRelative Specificity 99.6% (97.7%-99.9%) 95% Confidence IntervalsAccuracy99.3% (97.5%-99.9%) 95% Confidence IntervalsLOD1.6*102 TCID50/mLTest Time15 minutesShelf Life 24 MonthsStore Temperature2 – 30 °C
