The Need for Precise, Accurate, and Sensitive COVID-19 Tests

The Need for Precise, Accurate, and Sensitive COVID-19 Tests

Test kits on the market vary drastically in their limits of detection

October23rd,2020
Scott D. Hanton, PhD
David Muskat

David Muskat, CEO of Synergy Diagnostic Laboratory, identified the challenge in delivering COVID-19 tests to individuals early in the pandemic. In response, he and his team worked with PerkinElmer in converting Synergy into a high-throughput COVID-19 testing center in less than six weeks. Collectively the team has validated two saliva collection devices and submitted Emergency Use Authorizations (EUAs) for a nasal at-home collection kit.

Q: How has your diagnostic lab met the demand for COVID-19 testing?

A: Our focus is to get people back to work, back to living, and back to playing. We are very proud of the efforts made by SynergyDx during this pandemic. We have been fortunate to have great customers and have been able to deploy testing to those who need it the most, like our local fire and safety officers. We are now capable of delivering ~1,000 tests/shift and can increase capacity as needed.

Q: What COVID-19 assays are you running in your lab? How do they work?

A: Early in the pandemic, we decided to expand with the completely automated PerkinElmer workflow. Our validation work is core to our business. Once we knew our approach would work, it was simply a matter of securing the two FDA EUAs. Our COVID-19 assays are manufactured in the USA by PerkinElmer. Our assays target the N gene and the ORF1ab gene, providing precise identification of COVID-19. We have validated a number of sample collection matrices including the typical nasopharyngeal, mid-turbine nasal swabs, anterior nasal swabs, oropharyngeal, and also the very desirable saliva specimen.

Q: Can you tell me about your lab-developed saliva assay?

A: We have completed a COVID-19 assay for saliva specimen. At the start of the pandemic there was a desperate need to develop a non-invasive collection matrix for COVID-19. Although it proved to be difficult, we created a saliva solution for kids and the elderly. We have successfully validated the saliva matrix in our laboratory-developed test.

Q: What have been the greatest challenges your lab has faced with COVID-19 testing? 

A: One of the greatest challenges at the beginning of the pandemic for us was the lack of clear and concise regulatory guidelines for laboratory developed tests for COVID-19. The second challenge was finding the right laboratory talent. We need lab staff with the right mix of lab skills and agility to take on this task. Mostly, we were able to find and train new graduates to do this work. The third was finding the right PPE for the right price.

Q: What are the key instruments your lab is using for COVID-19 testing?

A: The PerkinElmer workflow consists of two JANUS G3 automated liquid handlers and one chemagic 360 closed loop extraction unit. The front-end sample preparation utilizes the JANUS G3 Primary Sample Reformattor, which transfers samples to the deep well plate in preparation for extraction. The chemagic 360 instrument represents the ideal solution for nucleic acid isolation.

Q: What else would you like to tell me?

A: I would like to stress to everyone the importance of testing, but not just test, test, test; I want to stress the importance of precise, accurate, and sensitive testing. Knowing if you have the virus is definitely important but knowing and trusting the testing protocols of a laboratory is equally important. It provides confidence in the results. Different manufacturers’ test kits vary drastically. A recent update on the FDA’s website shows the vast disparity between the limits of detection. PerkinElmer’s EUA is the most sensitive. This disparity demands the question: How many people are diagnosed incorrectly? The more sensitive the test, the more accurate the testing results and the fewer false negatives.