User Profile
Select your user profile

cobas® SARS-CoV-2 Duo

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

IVD For in vitro diagnostic use.
<b>cobas</b><sup>®</sup> SARS-CoV-2 Duo
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.

Form Successfully Submitted!
Thank you for your submission!
text

Dual target PCR design concept for accurate quantification

cobas SARS-CoV-2 Duo assay infographic
  • 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

Viral load result icon
Aid in diagnosis of at-risk patients

Reliable quantitative and qualitative results.

Viral load result icon
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 icon
Robust design

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

Scalability icon
Scalability

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

Coronavirus

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

Intended use

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. 

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

  1. https://www.who.int/westernpacific/health-topics/detail/coronavirus#:~:text=Coronaviruses%20(CoV)%20are%20a%20large,been%20previously%20identified%20in%20humans.
  2. 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

Overview

Detailed Specifications

Ordering Information

Compatible Instruments

...
    ...

    Technical Documents

    error errorMessage
    Sorry, we couldn't find the content you are looking for
    Please try again later