Product Overview

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. Intended use – the testing of “clinician-instructed self-collected (collected on site) and clinician-collected nasal swab specimens”.

Accuracy; robust, conserved regions for ORF-1a 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 minimize variability.

Hands-on Time; with only 3 manual interactions, up to 8 hours of walk away time.

Results

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 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.

About the cobas 6800/8800 Systems

Since 2014, the cobas 6800 and cobas 8800 Systems have established the new standard for routine molecular testing by delivering fully integrated, automated solutions that serve the areas of viral load monitoring, donor screening, sexual health and microbiology. Based on Nobel prize-winning PCR technology, the systems deliver proven performance with full automation, increased throughput, fast turnaround time and complete track connectivity validated for molecular testing, providing users with greater flexibility to consolidate their IVD and LDT testing to a single system while increasing overall workflow efficiencies.

The global install base for the cobas 6800 and 8800 Systems is 695 and 132 respectively. The systems provide up to 96 results in about three and a half hours and a total of 384 results for the cobas 6800 System and 1056 results for the cobas 8800 System in 8 hours. Both make it possible for labs to perform up to three tests in the same run with no pre-sorting required.The systems also enable up to eight hours (cobas 6800 System) and four hours (cobas 8800 System) of walk-away time with minimal user interaction. cobas 6800 and cobas 8800 Systems are the only fully automated molecular systems designated as moderately complex by the Clinical Laboratory Improvement Amendments (CLIA).

About Roche

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

FAQs

Where is the test made?

Roche designed the cobas® SARS-COV-2 Test in California and produces it in New Jersey. The cobas® 6800/8800 Systems are made in Switzerland.

How fast is the test?

After the lab starts the test, results are available in about 3 hours. The instruments can process up to 384 results (cobas® 6800 System) and 1,056 results (cobas® 8800 System) in an 8-hour shift.

How many test can you supply?

Roche began shipping tests to U.S. laboratories immediately. We expect to supply about 400,000 tests per week or 1.5 million tests per month to the U.S. and more than 3 million globally for these systems.

How long does it take to install a cobas® 6800 System or cobas® 8800 System in a hospital laboratory?

Under normal circumstances it takes about 1 week to install a new system in a laboratory that is properly prepared. This preparation involves ensuring adequate electric supply, assessment of environment for optimal performance, and careful planning for minimal disruption to laboratory operations. Please expect significant delays with new system installation due to unprecedented demand.