Our regulatory state is failing us, edition #1637

The U.S. Food and Drug Administration (FDA) has authorized the SalivaDirect PCR COVID-19 test created by the Yale School of Public Health for use with pooled saliva samples.

Pooled testing allows labs to combine saliva samples from multiple individuals into a single tube and process the batch as a single test. This approach maintains the clinical sensitivity associated with the real-time reverse transcription polymerase chain reaction tests — the gold standard for detecting SARS-CoV-2, the virus that causes COVID-19 — and gives labs the ability to process the tests far more quickly. The FDA authorizes Yale-designated laboratories to use the SalivaDirect test to pool as many as five samples at a time for SARS-CoV-2 testing.

That is November 2021In July 2020, Alex wrote: “Tyler and I have been pushing pooled testing for months.”

Better to have nothing in the meantime I guess!  In the meantime, only a handful of pooled spit tests have been approved.

Here is the full piece, via DR.

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