Solution reagent kit G01136-96

for microbiologydiagnosticRT-qPCR

The virellaSARS-CoV-2 mutant 2 real time RT-PCR Kit is an assay for the simultaneous detection of the SARS-CoV-2 spike protein mutations E484K and N501Y. 1 Intended Use The virellaSARS-CoV-2 mutant 2 real time RT-PCR Kit is an assay for the detection of point mutations in the spike protein of SARS-CoV-2 from biological specimens. The test kit is used with samples that have been prequalified with screening PCRs like virellaSARS-CoV-2 seqc real time RT-PCR Kit 2.0. The determination of a specific lineage requires another test kit, e. g. virellaSARS-CoV-2 mutant 2 Principle of the Test The virellaSARS-CoV-2 mutant 2 real time RT-PCR Kit contains specific primer and probe systems for the detection of two SARS-CoV-2 spike protein mutations present in most of the Variants of Concern. The two detected mutations are E484K (present in P.1 (Brazilian Variant) and B.1.351 (South African Variant)) and N501Y which is present in most of the Variants of Concern, including B.1.1.7 (UK Variant), P.1 and B.1.351. The result of the melting curve does not allow to determine a specific strain or variant of SARS-CoV-2, but it shows the presence of crucial point mutations that are suspected to alter the characteristics of the virus. Equipment and Reagents to be Supplied by User • Sterile microtubes • Pipets (adjustable volume) • Sterile pipet tips with filter • Table centrifuge • Vortexer • Real time PCR instrument • Optical PCR reaction tubes with lid or optical PCR reaction plate with optical foil • Optional: Liquid handling system for automation • PCR grade water