Chapter 7a – What to Do When There are Not Enough Lab Tests/Test Sites
It’s pretty amazing how circumstances have changed in the past couple of weeks, and I’m sure the readers of this blog are adapting to the necessary changes to protect our communities. You may have heard the news stories about the impact of testing delays on the spread of the virus (if you haven’t, here’s one from the New York Times). The regulations for clinical laboratories (that routinely test patient samples for results that are used to determine treatment) are stricter than those for research laboratories for good reason, to protect patients and maintain confidence in the validity of test results. I predict there will be ample opportunity to evaluate the decisions and process flow of the current pandemic in the future (there’s already enough material for a number of advanced degree theses in public health).
The originally approved test was the CDC’s PCR test, authorized for use under an Emergency Use Authorization (EUA) in February. However, only clinical laboratories certified to perform high complexity tests under the Clinical Laboratory Improvement Amendments (CLIA) are permitted to use this test for diagnostic results. Reports of inaccuracies with the CDC test has lead to a change in the FDA response including an immediately in effect guidance for laboratories that wish to develop, validate and use another test for SARS-CoV-2. This guidance has already been updated once, so it’s best to check the current version on the policy web page. The guidance describes the policy for laboratories and commercial manufacturers to help accelerate the use of tests they develop in order to achieve more rapid and widespread testing capacity in the United States. The FAQ page for the policy is regularly updated and includes a list of some of laboratories providing tests through the EUA process and answers to questions about the process.
We can expect that, as the number of validated tests and testing laboratories increases, we will naturally see an increase in cases. This makes our personal response even more important – please protect yourself, your family, and your community by staying updated on the latest requirements of your public health agency and Doing the Five.
Reach out to me if you want to know more or discuss your medical product development challenges.
Text Copyright © 2020 Katrina Rogers
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