For in vitro diagnostic use. Others cobas SARS-CoV-2 Duo IVD cobas® SARS-CoV-2 Duo For use under the Emergency Use Authorization (EUA) 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 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

Qualitative and quantitative assay for use on the cobas^® 6800/8800 Systems. Emergency Use Authorization (EUA) only.

IVD

Supports accurate qualitative and quantitative detection of SARS‑CoV‑2

Coronaviruses (CoV) are a large family of viruses that cause illness ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV).

SARS-CoV-2 is a novel coronavirus recently identified in humans. Signs of infection include respiratory symptoms such as cough, shortness of breath, difficulty breathing and fever. In more severe cases, pneumonia, severe acute respiratory syndrome, kidney failure and death can occur.¹

The cobas® SARS-CoV-2 Duo for use on the cobas® 6800/8800 Systems 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.

Would you like to know more about the cobas^® SARS-CoV-2 Duo Test?

Please submit your information in the following form to be contacted by a Roche representative with more details.

Dual target PCR design concept for accurate quantification

Polymerase (P)
Reporter dye (R)
Quencher (Q)
Open reading frame (Orf)
Spike protein gene (S)
Envelope protein gene (E)
Membrane protein gene (M)
Nucleocapsid protein gene (N)

Benefits of the cobas® SARS-CoV-2 Duo Test

Aid in diagnosis of at-risk patients

Reliable quantitative and qualitative results.

Viral load result

Viral load of a patient traceable to the WHO international standard in IU/mL in addition to the standard qualitative result.

Robust design

Dual target signal collected in single channel enables accurate quantification in the presence of mutation pressure.

Scalability

Benefit from fully automated cobas^® 6800/8800 Systems and their broad menu to expand COVID-19 testing solutions.

Test performance in individual samples²

Target

SARS-CoV-2
LoD (95% Probit)*

25.8 IU/mL
Specimen type

Nasopharyngeal and nasal
Positive agreement**

100% (30/30)
Negative agreement**

100% (30/30)

Key parameters

Kit Configuration

192 test cassettes
Sample type

Nasopharyngeal and nasal swab samples
Transport media

Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)
Min. amount of sample required

0.6 mL
Sample processing volume

0.4 mL
System Software

Runs with SW version 1.4 on cobas^® 6800/8800 Systems
Kit stability

90 days with 40 re-uses

Intended use

Emergency Use Authorization (EUA) only.

cobas^® SARS-CoV-2 Duo for use on the cobas^® 6800/8800 Systems 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.

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.

Registration status

This test has not been FDA cleared or approved;

This test has been authorized by FDA under an EUA for use by authorized laboratories;

This product has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner

References

https://www.who.int/westernpacific/health-topics/detail/coronavirus#:~:text=Coronaviruses%20(CoV)%20are%20a%20large,been%20previously%20identified%20in%20humans.
cobas® SARS-CoV-2 DUO (EUA) for cobas 6800/8800 Systems - Instructions for Use (IFU) (US-IVD)

¹ FDA Emergency Use Authorization (EUA), cobas^® SARS-CoV-2 Duo Test on cobas^® 6800/8800 Systems

*LoD determined with WHO International Standard for SARS-CoV-2 (NIBSC code 20/146)

**FDA Emergency Use Authorization (EUA), cobas^® SARS-CoV-2 Duo Test on cobas^® 6800/8800 Systems

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cobas^® SARS-CoV-2 Duo

Would you like to know more about the cobas^® SARS-CoV-2 Duo Test?

Dual target PCR design concept for accurate quantification