‘With the recent announcement extending social distancing guidance through the end of April , many are asking what this means for getting testing and who should undergo testing during these unprecedented times. There is a clear mandate for healthcare professionals to have ready, regular access to testing given the close proximity and increased risk in contracting COVID-19 they face, particularly front-line healthcare professionals interacting directly with patients. In addition, there is a clear utility for individuals either at risk, showing symptoms, or with a history of possible exposure to be offered testing. In this time of uncertainty, offering clear diagnostics to tell someone whether they have COVID-19 or simply have the common cold if they are showing symptoms is invaluable. Similarly, an individual with recent exposure who is worried about spreading to other members of their family that they might be self-isolating with may also benefit.
With shelter-at-home and other advice on halting non-essential travel the availability and impact of at-home testing is paramount. Appropriate at-home testing capabilities could significantly reduce the risk to individuals getting tested and any healthcare professional that would otherwise have to be involved to collect a specimen. It is also highly scalable and helps to alleviate some burden on the healthcare system which is currently stretched to the limit managing severe cases of COVID-19 requiring medical support.
Finally, it will be important to get clarification from the FDA on the ability to conduct at-home tests. On March 16th, 2020, the FDA issued guidelines meant to accelerate approval but a few days later issued guidance that these waivers ‘do not apply to at-home testing, including self-collection of samples to be sent to a clinical laboratory.” In their defense, the FDA’s response to this was to ensure the accuracy of test results. Given the time-sensitive nature of the decision regarding at-home testing and the critical importance of ensuring accuracy of results, further FDA guidance on this matter will be highly anticipated .’
Paldeep S. Atwal, MD, MBA, FACMG, FRCP (UK), FRCP (Glasg)
Clinical & Biochemical Geneticist
Medical Director, Genetic Services, PWNHealth