The cobas SARS-CoV-2 & Influenza A/B Test was approved

Roche Diagnostics Korea

Extend the cycle of workforce intervention to improve medical staff convenience

Clinical sensitivity & specification are identified at least 97%

Roche Diagnostics Korea announced on the 6th that it has obtained permission from the MFDS to "cobas SARS-CoV-2 & Fluenza A/B," which can diagnose COVID-19 and flu at the same time.

 

The cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay intended for simultaneous qualitative detection and differentiation of SARS-CoV-2, influenza A virus, and/or influenza B virus in nasal or nasopharyngeal swab samples collected from individuals suspected of a respiratory viral infection consistent with COVID-19 by their healthcare provider.

 

It is based on automated molecular diagnostic equipment 'covas 6800' and 'covas 8800', and can proceed from nucleic acid extraction to gene amplification, test, result analysis, and report through one-stop automation method.

 

The cobas 6800 provides 384 tests per eight hours and the cobas 8800 provides 960 tests.

 

The intervention of personnel to replace reagents and consumables reduced the cobas 6800 to once every eight hours and the cobas 8800 to once every four hours, respectively, improving the convenience of the medical staff's COVID-19 test.

 

This automated test prevents errors caused by manual work through an all-in-one solution that is inspected in a single equipment from extracting nucleic acids to producing test results, and also reduces the risk of contamination caused by external substances.

 

The cobas SARS-CoV-2 & Influenza A/B confirmed over 97% sensitivity and specificity through clinical studies.

 

For COVID-19, the sensitivity associated with the false (fake-positive) risk was 100.00%, and the specificity associated with the false (fake-positive) risk was 99.82%.

 

For influenza A, sensitivity and specificity were 97.14% and 99.04% respectively, and for influenza B, sensitivity and specificity were 100.00%.

 

The cobas SARS-CoV-2 & Influenza A/B was approved for EMA by the FDA in September 2020 and obtained European Medical Device Certification (CE) in the same month.

 

Johnny Tse Roche, CEO of Diagnostics Korea, said, "We expect high-capacity fully automatic cobas SARS-CoV-2 & Fluenza A/B not only improves the speed and convenience of testing, but also helps prevent the spread of infections and provide appropriate treatment for patients."