Description
Home Test COVID-19 Ag is a qualitative Lateral Flow immunoassay for the detection of SARS-CoV-2 nucleocapsid (NP) antigen in human nasal swab specimens. The test is designed for private use and enables individuals to screen for COVID-19 infection quickly and easily, without the need for laboratory equipment. The kit contains all necessary reagents and is intended exclusively for in-vitro diagnostic self-testing, following the instructions for use provided with the kit.
Specifications
LATERAL FLOW KIT CHARACTERISTICS:
■ Kit available in 1,2,5 and 20 tests
■ Cassette format
■ Confirmed to detect circulating variants.
■ Clinical performance with 774 nasal specimens (confirmed with RT-PCR assay) showed: 96.85% (95%CI: 93.29% to 98.84%) sensitivity & 99.31% (95%CI: 98.25% to 99.81%) specificity
■ Specimen: Nasal
■ Test time: 15 minutes
■ Shelf Life: 24 months
■ Storage: 4-30 °C
■ Visual interpretation of results
■ CE marked by BQS (Notified Body 2854)
■ For self-testing against Covid-19
