cobas® SARS-CoV-2 Test

Reliable solutions for emergency situations

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 (coronavirus) infection. Healthcare professionals use these tests 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 tests are for use on the automated cobas® 6800/8800 Systems under Emergency Use Authorization.

The test 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.

accuracy
Specificity
Contamination Control
THroughput
Simplicity
Hands-On Time
SARS-CoV-2 (coronavirus)

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.

To control the spread of the infection, WHO recommends regular hand washing, covering mouth and nose when coughing and sneezing, thoroughly cooking meat and eggs and avoiding close contact with anyone showing symptoms of respiratory illness.

 

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 nasopharyngeal and oropharyngeal swab samples from patients who meet COVID-19 clinical and/or epidemiological criteria. cobas® SARS-CoV-2 is for use only under Emergency Use Authorization (EUA) in U.S. laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity tests, and in U.S. laboratories certified under CLIA to perform high complexity tests, by clinical laboratory personnel who have received specific training on the use of the cobas® 6800/8800 Systems.

Results are for the detection of SARS-CoV-2 RNA that are detectable in nasopharyngeal and oropharyngeal swab samples during 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.Laboratories within the United States and its territories are required to report all positive results to the appropriate public health
authorities.

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. 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 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 specific detection of SARS-CoV-2 RNA that are detectable in 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.

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 the emergency use of in vitro diagnostic tests 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