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 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. 

The test is for use on the fully-automated cobas® 6800/8800 Systems under FDA Emergency Use Authorization (EUA) for individual samples and for pooled samples containing up to and including six individuals. This test, including the pooling workflow, is also available as a CE-IVD test 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. Two kit sizes accommodating either 192 or 480 test reactions are available.

Claims include:

  • Use of nasal, nasopharyngeal and oropharyngeal swab sample types
  • Use of collection and transport media
    • cobas PCR Media Dual Swab Kit
    • Uni Swab
    • 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

Accuracy

 

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

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 minimize 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). 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.

 

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 healthcare provider-instructed self-collected anterior nasal (nasal) swab 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. cobas® SARS-CoV-2 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.

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 healthcare provider-instructed self-collected nasal swab specimens (collected on site), or healthcare provider-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. Testing of pooled samples is limited to laboratories certified under CLIA, 42 U.S.C. §263a, that meet requirements to perform high complexity tests.

Results are for the detection of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in respiratory specimens during the acute phase of infection. 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 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 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 is only for use under the Food and Drug Administration’s Emergency Use Authorization.

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 healthcare provider-instructed self-collected anterior nasal (nasal) swab 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 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

FDA-Emergency Use Authorization, CE-IVD

 

In the United States:

- 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 test 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 Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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 Configurations 192 and 480 test cassettes
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 90 days with 40 re-uses for 192 test cassette and 20 re-uses for 480 test cassette