The McDonnell Genome Institute (MGI), under the leadership of Executive Director Dr. Jeffery Milbrandt, head of the Department of Genetics and MGI, and Director Rich Head, of the Genome Access Technology Center at MGI, led the development of a new saliva-based COVID-19 test. In March, as the world began to shift, this team knew they needed to find a way to positively impact our community. The main goal included assisting St. Louis and Missouri through the responsibility of bringing genomics to this area. 

Generating a test that fits into multiple limitations was a crucial piece of the response.  The test needed to be simpler, faster, and more economical while expanding to a large-scale population screening.

“People can collect the sample themselves, and it doesn’t require an uncomfortable nasal swab,” .. “Another problem with current testing is the shortage of certain lab supplies that are required to process viral samples. We have developed a method to process the saliva samples that doesn’t require these specialized supplies.”

Executive Director of MGI Dr. Jeff Milbrandt

A participant provides a sample by spitting into a test tube, a much better process than the typical deep nasal swab.  The results of the clinical study demonstrated a 100 percent agreement between the saliva results and the paired nasopharyngeal samples. Since MGI is a certified laboratory, known as a Clinical Laboratory Improvement Amendments (CLIA), it is able to provide the results in less than a day.

“The test we developed doesn’t require RNA extraction, a time-consuming and expensive step necessary for other COVID-19 tests. Our team found the right recipe, so to speak, to allow direct testing for the virus in saliva samples, and it works exceptionally well. The minimum number of viral particles that we can detect is extremely small — about six viruses per microliter. We’re well below the levels of virus that people produce when they have symptoms. We’re hopeful we’ll be able to detect positive cases even before people start having symptoms and in those who remain asymptomatic.”

Director of GTAC@MGI Rich Head

A developmental collaboration with a biotechnology company Fluidigm Corporation provided microfluidics and the first approved emergency use authorization (EUA) from the Food and Drug Administration on August 25.   Washington University has also filed a separate EUA application for the test differentiated from the fluidics.  Presently, the test and microfluidics can be used to identify new cases assisting with preventing further spread of the virus and encouraging the health and wellness of the community.

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