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RT-qPCR

The Clarigene SARS-CoV-2 IVD kit uses two viral RNA targets, nucleocapsid gene N and envelope gene E, which are specific to COVID-19, the firm said.

A SNP in the pan-SARS E gene has not affected patient results, but has raised concerns about the overall unavailability of commercial primer and probe information.

The FDA reissued the EUA after analyzing LabCorp data that showed the test could detect SARS-CoV-2 in a general asymptomatic population.

Quest expects to deploy the pooled sample technique at its laboratories in Chantilly, Virginia and Marlborough, Massachusetts by the end of next week with additional laboratories to follow.

The population genomics firm said that it can provide 2,000 COVID-19 PCR tests per day out of its San Diego lab while it awaits FDA Emergency Use Authorization.

The real-time RT-PCR multiplex test is intended for the simultaneous detection and differentiation of SARS-CoV-2, influenza A virus, and influenza B virus.

The firm's SmartChip platform consists of a high-throughput liquid dispenser and a PCR instrument and can provide more than 5,000 reactions in one run.

The company already offers an antibody test, Anti-SARS-CoV-2 Rapid Test, that it is distributing for its Chinese joint venture partner Autobio Diagnostics.

More than a dozen studies have been published to date directly comparing molecular diagnostic COVID-19 tests, with some detecting differences, mostly in sensitivity.

The Minneapolis-based firm believes the assay can successfully serve as a clinical indicator for patients at risk of developing high-grade prostate cancer (HGPC), thereby improving prostate cancer management. 

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