Solution reagent kit G01132-96

for microbiologydiagnosticRT-qPCR

The virellaSARS-CoV-2 mutant real time RT-PCR Kit is an assay for the simultaneous differentiation of the novel coronavirus (SARS-CoV-2) lineages B.1.1.7 (United Kingdom, UK), B.1.351 (South Africa, ZA) and P.1 (Brasilia, BRA) from biological specimens. 2 Principle of the Test The virellaSARS-CoV-2 mutant real time RT-PCR Kit contains four specific primer and probe systems for the detection of SARS-CoV-2 spike protein mutations. Each mutation is related to one specific dye. If one of the mutations is present, the specific channel will show no or a delayed signal. The mutations covered with this assay are del69/70 (FAM), del 241-243 (ROX), N501Y (HEX) and H655Y (Cy5). In case of B.1.1.7 (UK), B.1.351 (ZA) or P.1 (BRA), the HEX channel and one additional channel, depending on the mutation, will show no or a delayed signal (Table 7). In this case, the other two channels should show a normal signal. 4 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 7 Sample Material Starting material for virellaSARS-CoV-2 mutant real time RT-PCR Kit is RNA qualified SARS-CoV-2 positive by real time RT-PCR . Eluates with very low copy numbers resulting in CT values >32 are not suitable for testing with the virellaSARS-CoV-2 mutant real time RT-PCR. 8 Sample Preparation The eluted RNA has to be diluted 1:10 in Dilution Buffer to optimize the condition for the mutation detection.