For Research Use Only. Not for use in diagnostic procedures. Others cobas SARS-CoV-2 Duo RUO RUO cobas® SARS-CoV-2 Duo PID00000150 Qualitative and quantitivate test for use on the cobas® 5800/6800/8800 Systems 09626824190 KIT C58/68/88 SARS-COV2 DUO 192T RUO KIT C58/68/88 SARS-COV2 DUO 192T RUO 00875197007046 Reagents, kits 192T test cassette Not Available true Proposed UseThe cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems (cobas® SARS-CoV-2 Duo) is an automated real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens.cobas® SARS-CoV-2 Duo is intended for research use only and is not for use in diagnostic procedures. en cobas® SARS-CoV-2 Duo 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. The cobas® 5800 System is designed as one integrated instrument. Automated data management is performed by the cobas® 5800 System or the cobas® 6800/8800 software, which assigns 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 QS 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.External controls are processed in the same way with each cobas® SARS-CoV-2 Duo run. The test utilizes three external controls: a high titer positive, a low titer positive, and a negative control.Selective amplification of SARS-CoV-2 target nucleic acid from the sample is achieved by the use of a dual target virus specific approach from highly-conserved regions of SARS-CoV-2 located in the ORF 1a and ORF 1a/b non-structural regions. Selective amplification of RNA QS is achieved by the use of non-competitive sequence specific forward and reverse primers which have no homology with the SARS-CoV-2 genome.A thermostable DNA polymerase enzyme is used for amplification. The target and RNA QS sequences are amplified simultaneously utilizing a universal PCR amplifaction profile with pre-defined temperature steps and number of cycles.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.Amplified target is detected by cleavage of fluorescently labeled oligonucleotide probes. The cobas® SARS-CoV-2 Duo master mix contains two detection probes specific for SARS-CoV-2 target sequences and one for the RNA QS. The probes are labeled with target-specific fluorescent reporter dyes allowing simultaneous detection of SARS-CoV-2 target and RNA QS in two different target channels. The fluorescent signal of the intact probe is suppressed by the quencher dye. During the PCR amplification step, hybridization of the probes to the specific single-stranded DNA template results in cleavage by the 5' to 3' nuclease 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. Real-time detection and discrimination of PCR products are accomplished by measuring the fluorescence of the released reporter dyes for the viral targets and RNA QS. en