PCR Test Simultaneously Detects COVID-19 and Quantitatively Measures Viral Load Levels

The cobas SARS-CoV-2 Duo test from Roche Diagnostics (Basel, Switzerland) combines the standard qualitative result of a traditional SARS-CoV-2 PCR test with a quantitative result, which measures the viral load of a patient suspected of COVID-19. It is the first automated, real-time RT-PCR assay for the in vitro qualitative and quantitative detection of SARS-CoV-2 RNA in nasal and nasopharyngeal swab specimens. The test aims to help the healthcare community with contact tracing, patient triage and the approach to medical care.

The cobas SARS-CoV-2 Duo is an automated real-time RT-PCR assay for the qualitative detection of SARS-CoV-2 RNA in healthcare provider instructed self-collected nasal swab specimens (collected on site), and healthcare provider-collected nasal and nasopharyngeal swab specimens collected from individuals suspected of COVID-19 by their healthcare provider. The assay also performs quantitation of SARS-CoV-2 RNA levels in the collected specimen; however, only the qualitative result of cobas SARS-CoV-2 Duo is intended for use as an aid in the diagnosis of SARS-CoV-2 infection in patients suspected of COVID-19 by their healthcare provider.

The quantitative result is traceable to the World Health Organization (WHO) International Standard for SARS-CoV-2 RNA. The potential benefits from reporting a standardized viral load along with the qualitative result may help clinicians in the assessment and monitoring of infected patients across laboratories and over time. The US Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for the cobas SARS-CoV-2 Duo for use on the fully automated cobas 6800/8800 Systems.

"With the SARS-CoV-2 Duo test, we are now able to detect the COVID-19 virus and simultaneously measure the viral load in an individual,” said Thomas Schinecker, CEO Roche Diagnostics. “The test’s performance suggests that, by earlier and more accurately identifying infected patients, the results may open the path for healthcare providers to more efficiently organise their therapeutic and monitoring interventions.”

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