Description
Rapid Test FLU_COVID is a qualitative Lateral Flow immunoassay for the detection of Influenza A, Influenza B and SARS-CoV-2 antigens in human nasal or nasopharyngeal swab specimens. The test identifies nucleoprotein (NP) antigens from all three viruses on the same cassette, enabling fast, targeted screening during acute infection phases.
The kit contains all necessary reagents and is intended for professional, in-vitro diagnostic use. The nasal or nasopharyngeal specimen can also be used with ProGnosis Biotech’s other Rapid Tests for respiratory viruses ( Influenza A, Influenza B, SARS-CoV-2, RSV, Adenovirus), enabling testing for up to five different respiratory pathogens from a single sample.
Specifications
LATERAL FLOW KIT CHARACTERISTICS:
■ Kit available in 1, 5 and 20 tests
■ Cassette format
■ Clinical performance with 956 nasopharyngeal specimens (confirmed with RT-PCR assay) showed: 97.44 % (95%CI: 91.04% to 99.69%) sensitivity & 99.77 % (95% CI: 99.18% to 99.97%) specificity for Influenza A, 100% (95% CI: 75.29% to 100.00%) sensitivity & 99.68 % (95% CI: 99.07% to 99.93%) specificity for Influenza B and 99.2 % (95%CI: 97.67% to 99.83%) sensitivity & 99.83 % (95%CI: 99.05% to 100.00%) specificity for SARS-CoV-2
■ Clinical performance with 956 nasal specimens (confirmed with RT-PCR assay) showed: 96.15 % (95%CI: 89.17% to 99.20%) sensitivity & 99.77 % (95%CI: 99.18% to 99.97%) specificity for Influenza A, 100% (95%CI: 75.29% to 100.00%) sensitivity & 99.68 % (95%CI: 99.07% to 99.93%) specificity for Influenza B and 98,93 % (95%CI: 97.28% to 99.71%) sensitivity & 99.83% (95%CI: 99.05% to 100.00%) specificity for SARS-CoV-2
■ Specimen: Nasal or nasopharyngeal swab
■ Test time: 15 minutes
■ Shelf Life: 24 months
■ Storage: 4-30 °C
■ Visual interpretation of results
■ The kit is CE marked.
■ Professional use, POC/NPT
