10th August 2020 Product update: rapidmicrobiology staff writer
COVID-19 Testing Lab is Granted FDA-EUA for Speedy Viral RNA Extraction Technique
Quest Diagnostics has been granted US FDA Emergency Use Authorization (EUA) for a new laboratory technique that speeds the process of extracting viral RNA from specimens*.
This authorization is expected to enable the company to expand its daily capacity of COVID-19 molecular diagnostic tests on behalf of patients in the United States.
With the new FDA EUA, five of the company's laboratories in the U.S. may now run this new RNA extraction method, including on pooled specimens. Those laboratories are well situated geographically to address high testing demand in states where the virus has been surging. The labs are in San Juan Capistrano and Valencia, California; Lewisville, Texas; Lenexa, Kansas; Chantilly, Virginia; and Marlborough, Massachusetts.
Optimizing Capacity for Faster Testing
In its submission to the FDA, the company explained that "the method is needed to address availability of extraction supplies and increase testing capacity."
Currently, the company can perform 150,000 COVID-19 molecular diagnostic tests a day. The new method will add 35,000 tests a day in overall capacity over the next several weeks.
In addition, the company will be able to use specimen pooling with the new method to increase capacity even further.
Quest expects this innovation will help it to achieve average turnaround times of 1 day for "Priority 1" patients and 2-3 days for all other patients in coming weeks.**
The new extraction technique may be used with the Quest Diagnostics SARS-CoV-2 RNA, Qualitative Real-Time RT-PCR (Quest SARS-CoV-2 rRT-PCR), a proprietary test developed and validated by Quest Diagnostics for use on respiratory specimens from individuals suspected of COVID-19 by their healthcare provider. On July 17, the FDA granted an EUA for the test to be used with pooled specimens.***
*The method extracts RNA with the Mag-Bind Viral RNA Xpress Kit (Omega Bio-Tek) and the Hamilton MagEx STAR.
**Turnaround time for molecular diagnostic and antibody testing includes the time to transport a specimen to a Quest Diagnostics laboratory after collecting it at a patient service center or provider site to reporting results. Turnaround time can fluctuate with demand and vary by region. Priority 1 patients include hospital patients, pre-operative patients in acute care settings and symptomatic healthcare workers. We rely on the healthcare provider to indicate the level of priority of each patient specimen referred to us for testing.
***The Quest Diagnostics molecular test and self-collection kit have not been FDA cleared or approved, have been authorized by FDA under an EUA, and have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens
Date Published: 10th August 2020
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.