The one-step diagnostic test is designed to detect SARS-CoV-2 (the virus causing coronavirus) in as little as 30 minutes from a sample of saliva.
Developed by a team at Columbia, the test will be marketed by San Diego-based Sorrento under the name “Covi-Trace.” It holds all testing materials in a single tube and requires no specialized laboratory equipment, making it deployable for point-of-care, on-site or potentially at-home testing, according to a news release.
Dr. Zev Williams and his team at Columbia developed the test so that the extraction step which requires laboratory collection can be skipped and a person can collect a small sample of saliva in a cup and place it into a tube containing enzymes and reagents that can detect SARS-CoV-2 RNA. The tube is then placed in a heat block or water bath to keep it warm throughout the chemical reaction, which takes 30 minutes or less.
Williams and his team published preliminary study results in MedRxiv last month, sharing the evaluation of 60 samples, including 30 samples with the virus and 30 without. The study found sensitivity and specificity in 97% and 100% of the samples, respectively, and the ability to detect as few as one or two copies of the virus in a microliter of saliva.
Sorrento chairman & CEO Henry Ji said in the release that the company intends to “move rapidly to submit an emergency use authorization request to the FDA and prepare for full-scale production.”
“Testing for SARS-CoV-2 needs to be fast, frequent, and far-reaching,” Williams added. “We are delighted to work with Sorrento Therapeutics in the hope that COVI-TRACE may be scaled and deployed in the U.S. and around the world to combat the spread of COVID-19.”