- Joyce Gresko, Partner, Alston & Bird LLP
- David Morgan, President, Eurofins Transplant Diagnostics
- Troy Ayers, Vice President of Sales, Eurofins Microbiology
On Wednesday, LEAD1 Association (“LEAD1”) hosted its latest virtual forum to help its member institutions better understand all aspects of testing for COVID-19. The panel featured a familiar face for LEAD1 webinar attendees, Joyce Gresko (Partner at Alston & Bird; who is also the Legal Counsel at the American Clinical Laboratory Association (ACLA)), and two representatives at Eurofins, a worldwide laboratory testing company; David Morgan (President of Eurofins Transplant Diagnostics U.S.) and Troy Ayers (Vice President of Sales at Eurofins Microbiology Labs).
Gresko opened the forum by providing an overview of COVID-19 testing regulations. As a refresher for the LEAD1 membership, Gresko explained that COVID-19 tests are normally performed in reference laboratories (like Eurofins) or in a physician’s office or hospital. Gresko also outlined the various COVID-19 tests that can be performed, in addition to their specific uses. PCR and Antigen tests, for example, can be used to diagnose active and acute cases of COVID-19. Antibody tests, on the other hand, are used to verify whether someone has already been exposed to the virus. For antibody tests, various specimen types can be used for testing, such as nasal swabs, saliva and blood samples. It is also worth mentioning that specimen collection kits are now more widely available than they have been in recent weeks.
Next, Gresko noted the possible implications of testing results, and regulations, which determine who can receive testing results. A positive result from a PCR test, for example, indicates that the virus has been detected and the individual can spread it to others. A positive result from an antibody test indicates that an individual could have been exposed to COVID-19 (the result does not tell the individual if they are still infected). Furthermore, understanding who can receive the testing results is determined by Clinical Laboratory Improvement Act (CLIA) and Health Insurance Portability and Accountability Act (HIPPA) regulations. Gresko also explained that who pays for COVID-19 testing depends on whether the test is diagnostic (a common lab test), a screening test (returning to school) or a public health test (to understand how far the virus may have spread). Finally, Gresko described various best practices to consider when contracting with a lab. It is critical, for example, to ensure that the lab is CLIA certified, and complies with HIPPA regulations.
After Gresko presented, Eurofins reminded the audience that COVID-19 generally spreads “silently,” but that testing is still vital to suppressing the disease. Eurofins also provided rare insight regarding the testing of medical equipment. In addition to clinical testing, mask testing, for example, can identify infected individuals, while saving costs, and generally can have robust turnaround times. Eurofins, for example, noted that 10 masks can be pooled into one test, with turnaround times available within the next day, pending receipt from the lab. Another cutting-edge safety procedure that colleges and universities can consider is wastewater testing to monitor the presence of the virus in an overall population. In that regard, because college dormitories will most likely surround athletic facilities, regular wastewater testing can indicate the presence of COVID-19, and, thus, steer possible additional testing protocols.
More on some of the latest COVID-19 testing mechanisms can be found in the webinar recording.