USFDA Issues Emergency Use Authorization To Roche’s Coronavirus Vs. Flu Test

Roche’s widely-available, fully-automated cobas 6800/8800 Systems, are used to perform the SARS-CoV-2 & Influenza A/B Test.

The US Food And Drug Administration (USFDA) has given its Emergency Use Authorization to drug maker Roche for a test to quickly detect whether a patient has SARS-CoV-2 or one of two forms of influenza.

“With the approaching flu season, this new test is particularly important as SARS-CoV-2 and influenza infections can hardly be differentiated by symptoms alone. Now, with a single test, healthcare professionals can confidently provide the right diagnosis and most effective treatment plan for their patients,” Roche diagnostics head Thomas Schinecker said in a statement.

Roche’s widely-available, fully-automated cobas 6800/8800 Systems, are used to perform the SARS-CoV-2 & Influenza A/B Test.

These systems offer the fastest time to results with the highest throughput and the longest walk-away time available among automated molecular platforms.

The company claims that these systems can give 96 results in about 3 hours and 384 results for the cobas 6800 System and 1,056 results for the cobas 8800 System in an 8-hour shift. Roche is committed to delivering as many tests as possible within the limits of supply.

The test is another key addition to the comprehensive Roche diagnostic portfolio to help healthcare providers combat COVID-19 and make informed decisions for optimised patient care. Currently, this portfolio includes molecular, serology and digital solutions, which help during the initial stages of infection, during the recovery phase, as well as following the resolution of infection.

The cobas SARS-CoV-2 & Influenza A/B Test is a multiplex reverse transcription polymerase chain reaction (RT-PCR) assay.

It us used for the simultaneous qualitative detection and differentiation of SARS-CoV-2, Influenza A virus, and Influenza B virus in nasal or nasopharyngeal swab samples.

These samples are collected from people suspected of carrying a respiratory infection, and is not intended for the detection of Influenza C virus.

Under FDA EUA, the test can be taken by individuals suspected of a respiratory viral infection like COVID-19 by their healthcare provider. 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.

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