December 10, 2020 – Thermo Fisher Scientific (Waltham, MA) announced the availability of a new direct-from-saliva PCR test for COVID-19.
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 says.
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.
The company also introduced the Safe Campus Reopening Program to subsidize the cost of the test 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.
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 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.