Understanding COVID-19 Testing Slides – Alston & Bird LLP
Understanding COVID-19 Testing Slides – Eurofins
Panelists
- Joyce Gresko, Partner, Alston & Bird, LLP
- Sean Murray, President, Eurofins
- David Morgan, President, Eurofins Transplant Diagnostics
Webinar Recap
On Tuesday, LEAD1 Association (“LEAD1”) hosted a webinar to help its member institutions better understand all aspects of testing for COVID-19. The testing subject is critical for college sports because as testing advances, so does the hope for the eventual return of college sports. The panel featured 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 Sean Murray (President of Eurofins).
Gresko opened the panel by providing an overview of COVID-19 testing and relevant regulations. First, Gresko highlighted that COVID-19 tests are typically performed in reference laboratories (such as Eurofins) or in a physician’s office or hospital. Second, Gresko outlined the various COVID-19 tests performed and their specific uses. PCR and Antigen tests, for example, are used to diagnose active cases of COVID-19. Antibody tests, on the other hand, are used to determine whether someone has been previously exposed to the virus. Third, Gresko stated that various specimen types may be used for testing purposes such as nasal swabs, saliva specimen and blood samples (for Antibody tests).
Fourth, Gresko highlighted the ramifications of testing results and some of the regulations that determine who can ultimately get the results. A positive or detected result from a PCR test, for example, means that the virus has been detected and the individual would be presumed contagious – even without symptoms. A detected result from an Antibody test indicates that the person may have been previously exposed to COVID-19, however, this result does not tell the individual whether they are still infected. It is worth mentioning that a detected result from an Antibody test does not necessarily mean that a person is immune to the virus – in other words, science has not fully determined the ramifications of a positive Antibody test. Moreover, the determination of who gets the testing results are guided by CLIA and HIPPA regulations (e.g., where the tested individual must consent). Fifth, Gresko described who pays for COVID-19 testing noting that “there is no such thing as free lunch.” While Congress has allocated some money to states for testing, many schools, for example, are paying out of pocket. Who pays also depends on whether the test is diagnostic (e.g., a common lab test to determine if an individual is symptomatic), a screening test (such as returning to school or work) or a public health test (to determine how far the disease may have spread into a certain community). Sixth, Gresko outlined various things to consider when contracting with a lab. It is important, for example, to make sure that the lab is CLIA certified. Gresko also recommended that schools develop a “Master Services Agreement” when contracting with a lab and that individual agreements may be needed for each sport.
A couple other important notes from Gresko. First, most of the testing in the U.S. is being done by a handful of commercial labs (both for regular testing and specimen collection (e.g., specimens are taken to lab for the testing to be done). In this regard, most of the previous supply shortages with regard to testing have been addressed (at least for now). Second, on specimen pooling (which we have seen in the news related to college basketball), a laboratory technique to save money and use fewer resources (mostly used for asymptomatic people), the FDA has recently released guidance on this issue — specimen can be tested in batches and if no virus is detected in the batch, a conclusion may be drawn that no one whose specimen was included currently has COVID-19.
Eurofins then emphasized some of the key aspects of a good COVID-19 risk reduction program including physical separation, creative work arrangements and appropriate testing. In this regard, good COVID-19 risk reduction programs may include dedicated work spaces, athletes practicing in sub-groups (i.e., positions in football practicing and living together), requiring mask usage wherever feasible, time restrictions in locker rooms and “shift” workouts instead of team workouts. Eurofins made the critical point that even if colleges and universities take these actions, testing is still the cornerstone of any good risk reduction program due to the invisible nature of COVID-19 (people could therefore spread the disease unknowingly). To this point, unlike previous diseases, the majority of the spread of COVID-19 occurs “silently.”
In addition, Eurofins outlined four key elements of an effective COVID-19 testing program. First, it is important to design testing protocols, for example, by determining the frequency in which to test based on various considerations such as the confirmed local positive growth rate, number of people onsite, and budget available. Second, colleges and universities can organize testing by choosing a lab that is nearby and implementing simple protocols such as collecting specimen on the same day(s). Third, real-time data can be used to monitor testing results, for example, contact tracing via smartphones can be used to identify people who may have come into contact within an individual who has tested positive for COVID-19. Finally, reducing risk, such as implementing a testing regime can help colleges and universities measure the spread of COVID-19 and provide a better understanding of actions that may or may not be working.
The panel also addressed various situations as it relates to college sports specifically such as approaching situations in which a student-athlete may not be forthcoming with respect to their symptoms, testing that may be needed based on particular sport, the possible risks associated with pooling, the ramifications of COVID-19 coupled with the flu season and the NCAA’s guidance in this area.
In the next several weeks, LEAD1 will continue to be the place to be for all things COVID-19 testing for college sports. Please stay tuned.
