Please excuse my language, but Fuck the FDA. They STILL will not relinquish control over testing. They learn nothing. It’s as if they are purposefully trying to keep us in the dark, scared, without information about the relative risk we face when returning to at least semi-normal activities. As if they want us to be perpetually willing to submit to their dictates about what we may and may not do, without presenting hard evidence as to why it’s necessary. Excerpt below is from this post on FDA Law Blog.
“While FDA’s policy on March 16 addressed the FDA status of serological tests, it was silent about the status of these tests under the Clinical Laboratory Improvement Amendments (CLIA). CLIA is a separate law that governs laboratory testing. Among other elements, CLIA requires that tests be performed in appropriately certified laboratories, unless the test is categorized as “waived.” High-complexity tests can only be performed in those laboratories that are certified as high-complexity, which is a small minority of labs in the U.S.
“FDA announced its new policy on serological tests as a response to a Frequently Asked Question (FAQ) on its website (see FAQ webpage here). In the FAQ response, FDA states:
“‘While FDA has indicated that [tests offered prior to or without an EUA] may be appropriate for use in clinical laboratories and by healthcare workers at the point of care, the policies in the Policy for Diagnostic Tests for Coronavirus Disease-2019 do not provide a CLIA categorization and do not override any CLIA requirements. Therefore, in accordance with CLIA, tests offered under these policies are considered high complexity by default until or unless they are authorized and deemed to be appropriate, through an EUA authorization or general FDA review processes, to be performed as moderate or waived complexity tests.’
“This language may be opaque, but the impact is not: serological tests offered by manufacturers under the policy discussed above can only be performed in high-complexity laboratories. In other words, these tests – which are designed to be used at the point of care – can only be run in facilities that hold high-complexity CLIA certifications. Serological test samples could be collected at the point of care, but they would need to be transported to a high-complexity certified laboratory for testing, which defeats the purpose of a simple, rapid test. The result is reduced access to most serological tests.”