cobas® SARS-CoV-2 Test (for the COVID-19 Coronavirus)

Qualitative assay for use on the cobas® 6800/8800 Systems

For use under the Emergency Use Authorization (EUA) only

For in vitro diagnostic use 

Reliable solutions for emergency situations

The cobas® SARS-CoV-2 Test provides reliable and high-quality results for clinical decision-making for patients with suspected COVID-19 (coronavirus) infection. The cobas® SARS-CoV-2 Test is a qualitative assay that allows the detection of nucleic acids in samples from patients who meet COVID-19 (coronavirus) clinical and/or epidemiological criteria. The tests are for use on the automated, high throughput cobas® 6800/8800 Systems under Emergency Use Authorization.

Features and Benefits of the cobas® SARS-CoV-2 Test (for the COVID-19 Coronavirus)

 

The cobas® SARS-CoV-2 Test is a single-well dual target assay, which includes both specific detection of SARS-CoV-2 (COVID-19 Coronavirus) 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

 

Dual target assay, specific target unique to SARS-Cov-2 (COVID-19 Coronavirus) along with a conserved region of the E-gene

Specificity

 

Full-process controls with negative, positive and internal controls

Contamination control

 

A fully enclosed automated system with air lock doors and HEPA filtration

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
SARS-CoV-2 (COVID-19 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, also known as COVID-19) 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 vaccination, social distancing, wearing masks when distancing is not possible, regular hand washing and avoiding close contacts 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 inhealthcareprovider-instructed self-collectedanteriornasal(nasal)swab specimens (collectedon site), andhealthcare provider-collectednasal,nasopharyngeal, and oropharyngealswab specimenscollectedfromanyindividuals, 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 laboratoriescertified underClinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements toperform high or moderatecomplexity 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 fromhealthcare 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 inrespiratoryspecimens duringthe acute phase ofinfection.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 exposuresand 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 byqualifiedclinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR andon 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.

Registration Status

FDA-Emergency Use Authorization

 

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