Specifications

LATERAL FLOW KIT CHARACTERISTICS:

■ Lateral flow assay (cassette format)

■ For private use/home use/self-testing against Covid-19

■ Clinical Evaluation Study with 370 specimens (prior confirmed with RT-PCR assay) showed: 96.33% sensitivity & 99.62% specificity

■ Clinical performance with 528 nasal specimens (prior confirmed with RT-PCR assay) showed: 98.59% sensitivity & 99.74% specificity

■ Rapid Test Ag 2019-nCov is confirmed to detect variants B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429, B.1.427, B.1.2 , P1 (Gamma), P2, B.1.617.2 (Delta), B.1.617.3, C.37 (Lambda), P.3 (Theta), B.1.617.1 (Kappa), B.1.525 (Eta), B.1.526.1 B.1.526.2 (Iota) and the new variant B.1.1.529 (Omicron)

■ Visual interpretation of the results in 15 mins

■ Easy-to-use method

■ Using a minimally invasive nasal swab

■ Βy virtue of no 92778/05.10.2021 decision of the Greek National Organization of Medicines, valid till 31.12.2021, the product was acknowledged and provided as self-test to the greek Public in the frame of a Public procurement auction

■ The kit contains all reagents required for the immunoassay method

■ Shelf Life: 12 months | Storage 4-30 °C