For Research Use Only. Not for use in diagnostic procedures. Others cobas SARS-CoV-2 Variant Set 1 RUO cobas® SARS-CoV-2 Variant Set 1 RMD-6800-8800-SARS-007 Qualitative assay for use on the cobas® 6800/8800 systems cobas® SARS-CoV-2 Variant Set 1 is based on fully automated sample preparation (nucleic acid extraction and purification) followed by PCR amplification and detection. The cobas® 6800/8800 Systems consist of the sample supply module, the transfer module, the processing module, and the analytic module. Automated data management is performed by the cobas® 6800/8800 software, which assigns test results for all tests. Results can be reviewed directly on the system screen, and printed as a report.Nucleic acid from patient samples and added RNA Internal Control (RNA IC) molecules are simultaneously extracted. Nucleic acid is released by addition of proteinase and lysis reagent to the sample. The released nucleic acid binds to the silica surface of the added magnetic glass particles. Unbound substances and impurities, such as denatured protein, cellular debris and potential PCR inhibitors, are removed with subsequent wash steps and purified nucleic acid is eluted from the magnetic glass particles with elution buffer at elevated temperature. The external negative control is processed in the same way with each cobas® SARS-CoV-2 Variant Set 1 run.cobas® SARS-CoV-2 Variant Set 1 contains primers and probes to detect mutations E484K and N501Y, and deletion HV-69/70, as well as a sample check indicator (SCI) provided in a cassette suitable for 384 reactions (384T). Selective amplification of SARS-CoV-2 nucleic acid from the sample is achieved by the use of target-specific forward and reverse primers for the listed spike protein mutations and deletion.In addition the kit contains an internal control recognized by specific primers and probes. Selective amplification of RNA Internal Control is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the coronavirus genome. A thermostable DNA polymerase enzyme is used for both reverse-transcription and PCR amplification.The cobas® SARS-CoV-2 Variant Set 1 master mix contains detection probes which are specific for the detection and discrimination of mutations E484K, N501Y, deletion HV-69/70, SCI and the RNA Internal Control nucleic acid. Mutations E484K, N501Y, deletion HV-69/70, SCI and RNA Internal Control detection probes are each labeled with unique fluorescent dyes that act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage of the probe by the 5' to 3' exonuclease activity of the DNA polymerase resulting in separation of the reporter and quencher dyes and the generation of a fluorescent signal. With each PCR cycle, increasing amounts of cleaved probes are generated and the cumulative signal of the reporter dye increases concomitantly. Each reporter dye is measured at defined wavelengths, which enables simultaneous detection and discrimination of the amplified coronavirus target and the RNA Internal Control. The master mix includes deoxyuridine triphosphate (dUTP), instead of deoxythimidine triphosphate (dTTP), which is incorporated into the newly synthesized DNA (amplicon). Any contaminating amplicons from previous PCR runs are destroyed by the AmpErase enzyme [uracil -N-glycosylase], which is included in the PCR mix, when heated in the first thermal cycling step. However, newly formed amplicons are not destroyed since the AmpErase enzyme is inactivated once exposed to temperatures above 55°C. en The cobas® SARS-CoV-2 Variant Set 1 for use on the cobas® 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations E484K, N501Y and deletion HV-69/70 in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management.The cobas® SARS-CoV-2 Variant Set 1 assay is intended for research use only and is not for use in diagnostic procedures. en

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cobas^® SARS-CoV-2 Variant Set 1

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