Dr Michael Mina PDF article in New England Journal of Medicine November 26, 2020
Rethinking Covid-19 Test Sensitivity - A Strategy for Containment
https://www.nejm.org/doi/pdf/10.1056/NEJMp202...Tools=true
The penultimate paragraph speaks to the different focus of the FDA:
Currently, there is no FDA pathway for tests to be evaluated and approved for use in a regimen rather than as a single test or for their public health potential to reduce community transmission. The regulatory lens remains focused exclusively on clinical diagnostic tests, but new metrics could be applied to assess tests in light of an epidemiologic framework if their stated purpose is to reduce community prevalence of the virus. In such an approval pathway, trade-offs among frequency, limits of detection, and turnaround time would be expected and evaluated appropriately.
The final paragraph speaks about implementing a new strategy:
To defeat Covid-19, we believe that the FDA, the CDC, the National Institutes of Health, and others must encourage structured evaluations of tests in the context of planned testing regimens to identify those that will provide the best Covid filters. Frequent use of cheap, simple, rapid tests will accomplish that aim, even if their analytic sensitivities are vastly inferior to those of benchmark tests. Such a regimen can help us stop Covid in its tracks.
Rethinking Covid-19 Test Sensitivity - A Strategy for Containment
https://www.nejm.org/doi/pdf/10.1056/NEJMp202...Tools=true
The penultimate paragraph speaks to the different focus of the FDA:
Currently, there is no FDA pathway for tests to be evaluated and approved for use in a regimen rather than as a single test or for their public health potential to reduce community transmission. The regulatory lens remains focused exclusively on clinical diagnostic tests, but new metrics could be applied to assess tests in light of an epidemiologic framework if their stated purpose is to reduce community prevalence of the virus. In such an approval pathway, trade-offs among frequency, limits of detection, and turnaround time would be expected and evaluated appropriately.
The final paragraph speaks about implementing a new strategy:
To defeat Covid-19, we believe that the FDA, the CDC, the National Institutes of Health, and others must encourage structured evaluations of tests in the context of planned testing regimens to identify those that will provide the best Covid filters. Frequent use of cheap, simple, rapid tests will accomplish that aim, even if their analytic sensitivities are vastly inferior to those of benchmark tests. Such a regimen can help us stop Covid in its tracks.
