4th Coronavirus - Influenza Combo Test Authorized

The first commercial test for fully automated high-throughput systems to detect and differentiate SARS-CoV-2 and influenza viruses, with a single sample from patients suspected by their healthcare provider of having respiratory viral infection consistent with COVID-19 disease, was authorized by the U.S. FDA on September 4, 2020.

Switzerland based Roche's cobas® SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription-polymerase chain reaction (RT-PCR) assay that can provide up to 96 test results in about 3 hours.

The test runs on the cobas 6800/8800 Systems and has a full-process negative control, positive control, and internal control. Multiplexing will increase lab efficiency and save resources in the labs. Negative results do not preclude infection from SARS-CoV-2 or Influenza virus and should not be used as the sole basis of treatment or other patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.

This announcement is the 4th flu-coronavirus combination test authorized by the FDA during the COVID-19 pandemic of 2020.