cobas® SARS-CoV-2 Test

cobas® SARS-CoV-2 test kit

Reliable, high-volume testing for the detection of novel coronavirus (SARS-CoV-2)

 

The cobas® SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for the improved management of COVID-19 patients and to reduce the risk of SARS-CoV-2 infection. Healthcare professionals can use this test to assess if patients are at risk of developing disease by this pathogen, which can contribute to severe upper respiratory distress, complications, and potential death. 

The test is for use on the fully-automated cobas®  6800/8800 Systems for individual samples and for pooled samples containing up to and including six individuals. This test is also available as a CE-IVD test for countries accepting the CE-mark. Pooling workflow is not available for countries accepting the CE-mark.

 

Features and benefits of the cobas® SARS-CoV-2 test

 

The cobas® SARS-CoV-2 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.

Claims include:

  • Expansion of the claimed specimen types to include nasal samples collected according to standard collection technique using flocked or polyester-tipped swabs and immediately placed in 3 mL of Copan Universal Transport Medium (UTM-RT) or BD Universal Viral Transport (UVT)

  • Addition of the following as acceptable collection and transport media for nasal swabs:

    • cobas®  PCR Media Dual Swab Kit 

    • cobas®  PCR Media Uni Swab Kit 

    • cobas®  PCR Media Kit for nasal swabs

    • and 0.9% Physiological Saline

Accuracy

 

Robust, conserved regions for ORF-1a/b and E-gene regions

Specificity

 

Full-process controls with negative, positive and internal controls

Contamination control

 

A fully enclosed automated system 

Throughput

 

The systems provide up to 96 results in about three hours and a total of  384 results for the cobas® 6800 System and 1056 results for the cobas® 8800 System in 8 hours 

Simplicity

 

Ready to use reagents and controls minimise variability

Hands-on Time

 

With only 3 manual interactions, up to 8 hours of walk-away time 
Severe Acute Respiratory Syndrome Coronavirus 2 (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). The novel coronavirus (SARS-CoV-2) is a new strain which has not previously been 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.

 

Intended use

Intended use

cobas® SARS-CoV-2 for use on the cobas® 6800/8800 Systems is a real-time RT-PCR test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in clinician-instructed self-collected nasal swab specimens (collected on site), and clinician-collected nasal, nasopharyngeal and oropharyngeal swab samples from patients with signs and symptoms suggestive of COVID-19 (e.g., fever and/or symptoms of acute respiratory illness). 

Results are for the detection of SARS-CoV-2 RNA that are detectable in nasal, nasopharyngeal and oropharyngeal swab samples during infection. Positive results are indicative of SARS-CoV-2 RNA detection, but may not represent the presence of transmissible virus.

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 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. 

Registration status

CE-IVD

 

Test performance in individual samples

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Test performance in individual samples

TARGET POSITIVE AGREEMENT NEGATIVE AGREEMENT LoD (95% Probit)
SARS-CoV-2 100% 100% 0.007 TCID50/mL 
pan-Sarbecovirus 100% 100% 0.004 TCID50/mL

 

Key parameters

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Key parameters

PARAMETER PERFORMANCE
Kit Configuration 192 test cassette and 480 test cassette
Sample Type Nasal, nasopharyngeal and oropharyngeal swab
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 andoropharyngeal swab   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 µL
Test duration Results are available within less than 3.5 hours after loading the sample on the system
System software Runs with SW versions 1.2, 1.3, and 1.4
Kit stability

192 test cassette - 90 days with 40 re-uses

480 test cassette - 90 days with 20 re-uses