For in vitro diagnostic use. Others cobas SARS-CoV-2 Duo IVD cobas® SARS-CoV-2 Duo PID00000147 Qualitative and quantitative assay for use on the cobas® 6800/8800 systems 09 500 111 190 9 500 111 190 09500111190 9500111190 09500111190 KIT C58/68/88 SARS-COV2 DUO 192T cobas SARS-COV-2 DUO 00875197007022 Reagents, kits 1 Kit 192 tests true 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 qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal (anterior nares and mid-turbinate) swab specimens (collected on site), and healthcare provider-collected nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. This assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider. cobas® SARS-CoV-2 Duo is for use only under Emergency Use Authorization (EUA) in laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high or moderate complexity tests. Results are for the detection of SARS-CoV-2 RNA. SARS-CoV-2 RNA is generally detectable in nasal (anterior nares and mid-turbinate) and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA. At this time, correlation of viral load with a specific clinical diagnosis, prognosis or patient management decision has not been clinically established. Patient management should therefore be based on the qualitative result upon consideration of clinical observation, patient history and other diagnostic information. The numerical values for the viral load are for information only. Positive results do not rule out bacterial infection or co- infection with other viruses. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, recent exposures and epidemiological information. Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities. cobas® SARS-CoV-2 Duo is intended for use by qualified clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and on the use of the cobas® 6800/8800 Systems. cobas® SARS-CoV-2 Duo is only for use under the Food and Drug Administration’s Emergency Use Authorization. en cobas® SARS-CoV-2 Duo for use on the cobas® 5800/6800/8800 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 healthcare provider-instructed self-collected nasal (anterior nares and mid-turbinate) swab specimens (collected on site), and healthcare provider-collected nasal and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. cobas® SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of patients suspected of COVID-19 by their healthcare provider. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, recent exposures, and epidemiological information. 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. Automated data management is performed by 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 amplification 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 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® 5800 system is designed as one integrated instrument. 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® 5800 or the cobas® 6800/8800 systems 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 amplification 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

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