Solution reagent kit G01138 series

for microbiologydiagnosticRT-qPCR

The virellaSARS-CoV-2 mutant 3 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 2 Principle of the Test The virellaSARS-CoV-2 mutant 3 real time RT-PCR Kit contains specific primer and probe systems for the detection of two SARS-CoV-2 spike protein mutations present in the Delta Variant of SARS-CoV-2 (B.1.617.2). The two detected mutations are L452R and P681R. Additionally, the combination of the mutations N440K, G446S, S477N, T478K, N679K and P681H, which are present in the Omicron variant of SARS-CoV-2 (B.1.1.529) can be detected. The test does not distinguish the lineages BA.1 from BA.2 (stealth version), both are detected as Omicron variant. 6 Warnings and Precautions Read the Instruction for Use carefully before using the product. Before first use check the product and its components for: • Use of this product is limited to personnel specially instructed and trained in the techniques of real time PCR procedures. • Specimens should always be treated as infectious and/or biohazardous in accordance with safe laboratory procedures. • Avoid microbial and nuclease (DNase/RNase) contamination of the eluates and the components of the kit. • Always use DNase/RNase-free disposable pipet tips with aerosol barriers. • Always wear protective disposable powder-free gloves when handling kit components. • Use separated and segregated working areas for (1) sample preparation, (2) reaction setup and (3) amplification/detection activities.