cobas® SARS-CoV-2 Variant Set 1 (RUO)

SARS-CoV-2 Variant 1 (RUO)

Detect and differentiate mutations N501Y, E484K, del 69-70 in SARS-CoV-2 variants

To aid in the public health management of emerging coronavirus variants

 

Viruses mutate over time, and SARS-CoV-2 is no exception. Reliable detection of mutations arising in emerging variants helps researchers understand the prevalence of variants in the population and conduct epidemiologic surveillance for the COVID-19 pandemic.

Variants of SARS-CoV-2 have been circulating globally ever since the genetic sequence of the original strain was first made public in the beginning of 2020. While most mutations do not affect the clinical impact of the virus, in fall of 2020, WHO reported that mutations in several emerging variants may cause a change in the transmissibility and/or disease severity of COVID-19, potentially impacting diagnostics, therapeutics, vaccines and other important public health measures to combat the pandemic.1

The cobas® SARS-CoV-2 Variant Set 1 Test for use on the cobas® 6800/8800 Systems is a high-throughput, research use only multiplex assay for the qualitative detection and differentiation of N501Y, E484K and del 69-70 mutations in SARS-CoV-2. These mutations are of particular importance as they could alter the way the virus enters the cell or make it more difficult for antibodies to target the virus, suggesting increased transmissibility and possibly decreased theraputic and vaccine efficacy.2

The cobas® SARS-CoV-2 Variant Set 1 Test is optimized for use on the cobas® 6800/8800 Systems. Highly streamlined workflow enables laboratories to rapidly ramp up and respond to evolving pandemic needs.

Benefits of the cobas® SARS-CoV-2 Variant Set 1 Test 

Efficient workflow
Efficient workflow

Increase workaway time with ready-to-use, pre-filled cassettes and predefined
software protocol (USAP) recognizable by RFID tag.

Optimized design
Optimized design

Reduce complexity of testing, alleviate upfront assay design and minimize variability with pre-validated assay and standardized reagents and consumables.

Consolidated testing
Consolidated testing

Meet high-volume demands with the cobas® 6800/8800 Systems and expand assay offerings to other Roche molecular COVID-19 solutions and beyond.

Proposed use

The cobas® SARS-CoV-2 Variant Set 1 for use on the cobas® 6800/8800 Systems is an automated, multiplex, real-time RT-PCR assay for the qualitative detection and differentiation of SARS-CoV-2 mutations N501Y, deletion HV-69/70 and E484K in e.g., nasal and nasopharyngeal swab specimens from patients with known SARS-CoV-2 infection to support the understanding of variant epidemiology for Population Health Management.

The cobas® SARS-CoV-2 Variant Set 1 assay is intended for research use only and is not for use in diagnostic procedures.

Registration status

Research Use Only. Not for use in diagnostic procedures.

 

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References

  1.  https://www.who.int/csr/don/31-december-2020-sars-cov2-variants/en/. Accessed March 2021.
  2. https://www.cdc.gov/coronavirus/2019-ncov/cases-updates/variant-surveillance/variant-info.html. Accessed March 2021.
  3. cobas® SARS-CoV-2 Variant Set 1 for use on the cobas® 6800/8800 Systems (package Insert), Pleasanton, CA, Roche Molecular Systems, Inc. 2021

 

Key parameters

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Key parameters

Parameters Description
Targets N501Y, E484K, del 69-70
Kit configuration 384 test cassette
Minimum amount of sample required  0.6 mL
Sample processing volume 400 µL
System software cobas® 6800/8800 System Software 1.3 and 1.4 USAP. Not compatible with Software 1.2
User interactions Pre-filled cassette. Analysis package software with preset run parameters.*
Test duration Results are available within less than 3.5 hours after loading the sample on the system
Open kit stability 90 days with 40 re-uses
Regulatory label For Research Use Only. Not for use in diagnostic procedures

*cannot be combined in runs with IVD assays or other tests outside of potential future variant tests.