PCR COVID-19 tests are the gold standard for accurate detection of viral RNA but typically require longer turnaround times than antigen tests performed at the point of care. This is because conventional PCR tests require trained personnel to perform extraction, amplification and detection steps using specialized equipment in a laboratory setting. However, an emergency use authorization recently issued by the FDA now allows for the use of a rapid PCR testing device that can deliver results in just 15 minutes, opening up new possibilities for point-of-care testing to more effectively manage the spread of the virus.
The new rapid PCR test device, called the Diagnostic Analyzer for Specific Hybridization (DASH), was developed at Northwestern University’s Center for Innovation in Global Health Technologies (CIGHT) and is being commercialized by the Northwestern spinoff company Minute Molecular Diagnostics. The compact device can be operated by non-laboratory personnel and requires the user to simply place a nasal swab into a chamber within a small cartridge, then insert the cartridge into the testing unit. The DASH unit displays a positive or negative result on an integrated touchscreen once the test is complete. The FDA issued emergency use authorization for the testing system on March 15, 2022.
Like conventional PCR tests, DASH uses reverse transcription-quantitative PCR (RT-qPCR) to detect viral DNA and targets are extracted, purified and concentrated with sequence specific capture probes, according to the Minute Molecular website. The device also has 4-channel capability for multiplexing tests. The unit’s small footprint and ease-of-use can allow for point-of-care testing at hospitals and clinics as well as other settings such as schools, congregate care settings and workplaces, according to Minute Molecular Co-Founder and Chief Scientific Officer Sally McFall.
“What distinguishes DASH from existing options are its simplicity, speed and PCR-level accuracy,” said Dr. Chad Achenbach, associate professor of medicine (infectious diseases) and preventative medicine at Northwestern University Feinberg School of Medicine, who led DASH’s clinical evaluation. “The DASH interface walks the user through all the steps making it just as easy to use as a coffee maker. DASH is ideal for point-of-care testing in clinics, corporate or community settings.”
Development of DASH was partially funded by a $21.3 million grant from the National Institutes of Health Rapid Acceleration of Diagnostics (RADx) received by Minute Molecular last year. The company is currently seeking government and private partnerships to help accelerate delivery of the rapid analyzer.
Photo: A person puts a sample into the DASH unit. Credit: Minute Molecular/Northwestern University