Thermo Fisher Scientific announced today the availability of a new direct from saliva PCR test for COVID-19 to enable widespread, high-frequency surveillance testing. The Applied Biosystems TaqCheck SARS-CoV-2 Fast PCR Assay uses raw saliva samples and simplifies lab workflows using instruments that are widely available globally to deliver reliable data quickly.

The company also introduced the Safe Campus Reopening Program to subsidize the cost of theĀ testĀ for U.S. colleges, universities and post-secondary institutions. Availability of this program coincides with recent guidance issued by the Centers for Disease Control and Prevention (CDC) that calls for expanded COVID-19 surveillance using PCR-based tests with turnaround times within 24-48 hours.

By performing the test directly from raw saliva and eliminating the need for equipment, materials, time and labor associated with nucleic acid extraction, the TaqCheck SARS-CoV-2 Fast PCR Assay helps labs meet the CDC turnaround time recommendations.

“Thermo Fisher scientists are continually working to answer the call as public and private institutions take proactive measures to protect their communities,” said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. “The TaqCheck Fast PCR Assay breaks new ground and provides global communities access to affordable surveillance testing that is easy-to-implement and delivers trusted quality and reliability so they can manage the spread of COVID-19 and return to a sense of normalcy.”

Direct from saliva PCR testing is already being implemented at the University of Illinois Urbana-Champaign (UIUC) to reduce the cost and complexity of on-campus testing. With its raw saliva direct to PCR protocol and comprehensive on-campus surveillance program, UIUC is currently processing more than 10,000 samples a day in as little as four hours.

UIUC is currently collaborating with Thermo Fisher to determine how the TaqCheck SARS-CoV-2 Fast PCR Assay could further improve UIUC’s existing workflow. “The new assay produced highly correlative results with UIUC’s current direct PCR testing and reduced thermocycling time by one-third,” said Dr. Leyi Wang, clinical assistant professor who leads UIUC’s COVID-19 data analysis and validation studies.

The TaqCheck Fast PCR Assay is ideal for institutions of higher learning with existing laboratories. Universities that do not have labs on campus can also benefit by partnering with third-party testing providers. These reference labs can leverage the assay’s workflow to support significant increases in testing volume.

The TaqCheck SARS-CoV-2 Fast PCR Assay is available globally for research use only. Thermo Fisher plans to seek emergency use authorization (EUA) in the U.S. and CE-IVD in Europe in early 2021.

Source: Company Press Release