Description
Rapid Test Ag 2019-nCoV is a qualitative Lateral Flow immunoassay for the detection of the SARS-CoV-2 nucleocapsid protein (NP) in human nasal or nasopharyngeal swab specimens. The NP antigen is highly conserved and abundantly expressed during the acute phase of infection, making it a reliable diagnostic target.
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, enabling testing for up to five different respiratory pathogens ( Influenza A, Influenza B, SARS-CoV-2, RSV, Adenovirus) from a single sample.
Specifications
LATERAL FLOW KIT CHARACTERISTICS:
■ Kit available in 1,2, 5, 20 and 40 tests
■ Cassette format
■ Clinical performance with 528 nasal specimens (confirmed with RT-PCR assay) showed: sensitivity: 98.59% (95%CI:95.00% to 99.83%) & specificity: 99.74% (95% CI: 98.57% to 99.99%)
■ Clinical performance with 613 nasopharyngeal specimens (confirmed with RT-PCR assay) showed: sensitivity: 95.56% (95% CI: 90.58% to 98.35%) & specificity: 99.58% (95%CI: 98.50% to 99.95%)
■ Confirmed to detect circulating variants. .
■ 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
