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cobas® SARS-CoV-2 Qualitative Test

PCR qualitative detection of SARS-CoV-2 on cobas® 5800/6800/8800 Systems with expanded sample types.

cobas® SARS-CoV-2 Qualitative Test
Robust, high-volume SARS-CoV-2 testing providing reliable results important for clinical decision-making

The cobas® SARS-CoV-2 Qualitative Test provides reliable and high-quality results for the improved management of COVID-19, in individuals suspected of COVID-19 by their healthcare provider, and those without symptoms* or other reasons to suspect COVID-19. Healthcare professionals can use this test to assess if patients are at risk of developing the disease by this pathogen, which can contribute to severe respiratory distress, complications, and potential death.

This test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples.

 

*For use with the CE-IVD test only

Features and benefits of the cobas® SARS-CoV-2 Qualitative Test

The cobas®SARS-CoV-2 Qualitative Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 and pan-Sarbecovirus detection for the Sarbecovirus subgenus family that includes SARS-CoV-2. The assay has a full-process negative control, positive control and internal control. Two kit sizes accommodating either 192 or 480 test reactions are available.

Claims may include:

  • Use of nasal, nasopharyngeal and oropharyngeal swab sample types
  • Use of saliva specimens*
  • Use of collection and transport media
    • cobas PCR Media Dual Swab Kit
    • cobas PCR Media Uni Swab Kit
    • cobas PCR Media Kit
    • Copan Universal Transport Media (UTM-RT)
    • BD™ Universal Viral Transport (UVT)
    • 0.9% Physiological Saline 

Please refer to the IFU for acceptable sample type and collection device combinations

 

*For use with the CE-IVD test only

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Accuracy

 

Robust performance achieved by targeting conserved regions within the ORF 1a/b and E genes

Simplicity & efficiency

 

Ready to use reagents and controls minimizing variability while simplifying the workflow and reducing risk of error

Specificity

 

Full-process controls with negative, positive and internal controls

Hands-on Time

 

With only minimal manual interactions, up to 8 hours of walk away time

Expanded sample types

 

Nasal, nasopharyngeal and oropharyngeal swab samples & saliva specimens3
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS‑CoV‑2)

Since the start of COVID-19 pandemic, Roche is focused on bringing effective diagnostic solutions to healthcare communities worldwide in the fight against the disease.

As communities across the globe still need effective solutions for COVID-19, Roche continues to invest in diagnostics to ensure there are testing options available to healthcare communities and patients worldwide.

Test performance in individual samples*

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Test performance in individual samples*

TARGET LoD (95% Probit)
SARS-CoV-2 200 IU/mLa
0.004 TCID50/mLb
pan-Sarbecovirus 102 IU/mLa
0.007 TCID50/mLb

* cobas® SARS-CoV-2 Qualitative assay for use on the cobas® 5800/6800/8800 Systems Instructions for use. (09343784001-03EN, Doc. Rev. 3.0), Pleasanton, CA. Roche Molecular Systems, 2021.

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

b one TCID50/mL is equal to 7,393 genome equivalents by ddPCR (per vendor’s Certificate of Analysis, USA-WA1/2020, infectious culture, Cat No NR-52281, Lot 70033175)

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SPECIMEN TYPE TARGET POSITIVE AGREEMENT NEGATIVE AGREEMENT
Nasopharyngeal SARS-CoV-2 97.2% 99.9%

Key Parameters

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Key Parameters

PARAMETER PERFORMANCE
Kit Configuration 192 and 480 test cassettes
Sample Type Nasal, nasopharyngeal and oropharyngeal swab
Saliva*
Transport media for nasal swabs

cobas® PCR Media Dual Swab Kit, cobas® PCR Media Uni Swab Kit, cobas® PCR Media Kit for nasal swabs, 0.9% Physiological Saline, Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)
Transport media for nasopharyngeal and oropharyngeal swab Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)
Min. amount of sample required Swab speciment types: 0.6 mL
Liquified saliva: 1.2 mL
Sample processing volume Swab specimen types: 0.4 mL
Liquified saliva: 0.85 mL
System software Runs with SW version 1.4 on cobas® 6800/8800 Systems and SW version 1.0 on cobas® 5800 System
Kit stability 90 days with 40 re-uses for 192 test cassette on cobas® 5800/6800/8800 Systems; 40 re-uses for 480 test cassette on cobas® 5800 System and 20 re-uses for 480 cassette on cobas® 6800/8800 Systems
*For use with the CE-IVD test only
Intended Use

Intended Use

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in healthcare provider-instructed self-collected anterior nasal (nasal) swab and saliva specimens (collected on site), and healthcare provider-collected nasal, nasopharyngeal, and oropharyngeal swab specimens collected from any individuals, including those suspected of COVID-19 by their healthcare provider, and those without symptoms or other reasons to suspect COVID-19.

This test is also intended for the qualitative detection of nucleic acids from SARS-CoV-2 in pooled samples containing up to and including six individual samples from clinician-instructed self-collected nasal swab specimens (collected on site), or clinician-collected nasal, nasopharyngeal, and oropharyngeal swab specimens. Negative results from pooled samples should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually. Specimens included in pools with a positive or presumptive positive result must be tested individually prior to reporting a result. Specimens with low SARS-CoV-2 RNA concentrations may not be detected in sample pools due to the decreased sensitivity of pooled testing.

Results are for the detection of SARS-CoV-2 RNA. Positive results are indicative of SARS-CoV-2 RNA detection, but may not represent the presence of transmissible virus. 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, and epidemiological information.

cobas® SARS-CoV-2 Qualitative is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures.

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasal and nasopharyngeal specimens collected from symptomatic individuals suspected of COVID-19 by their healthcare provider.

Results are for the detection of SARS-CoV-2 RNA. 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 pathogens.

Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Results are meant to be used in conjunction with clinical observations, patient history, recent exposures and epidemiological information, and laboratory data, in accordance with the guidelines provided by the relevant public health authorities. cobas® SARS-CoV-2 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® 5800/6800/8800 Systems.

Registration Status

CE-IVD & FDA 510(k) clearance

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