Most who test Pos on PCR are No Longer contagious-Esp if no symptoms
Millions have Isolated entirely AFTER contagious
(Rapid tests don’t cause this)
Why won’t FDA evaluate tests for how ppl use them: to answer “Am I Infectious?
PCR has its place…
For medical diagnostics OR when you know that someone was recently exposed etc
But 2 years in, we continue to use a Binary PCR to tell people they need to isolate, without using the right cutoff or tests to ask the public health question: am I infectious?
2/
Currently, FDA evaluate tests ONLY based on their medical diagnostic utility
2 years in to the worst public health crisis in modern history, there STILL is NO effort at FDA to regulate tests based on their ability to answer relevant PUBLIC HEALTH questions.
Why?
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Rapid tests are exceptionally good at detecting ppl who are infectious and need to isolate - and not weeks after they’ve been infectious
Why do we still pretend like PCR is a gold standard when it is absolutely NOT specific to what most people besides doctors care about?
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More generally why doesn’t FDA have a regulatory path for anything having to do w Public Health?
Has the pandemic not demonstrated how important Public Health tools are?
Why try to make them fit in an inappropriate Medical tool Box?
Public Health has distinct requirements!
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Its finally dawning on me that there is an endless supply of ppl - many in public health & medicine - who will not understand science of testing & how to interpret the sea of (poorly performed) studies (including by CDC)
This is a failure of messaging by Federal government
1/
Confusion around rapid tests is becoming immensely harmful at local levels as every small town and city has their own decision makers trying to wade through a mix of confusing and often conflicting messages, with no guidance and no idea who or what to trust.
2/
The frustrating thing is that this doesn’t need to be hard!
The science and biology of rapid Ag tests is extremely simple/straightforward if we allow their formal evaluation to be towards why we take the tests: answering “Am I infectious” or “Do I need to isolate still?”
3/
Sorry - if anyone didn’t get the joke - I Was making fun of the use of the word “Breakthrough” as a positive to market just because the word these days is so caught up w Breakthrough Infections.
In addition the AVERAGE case mentioned was based on viral loads where ppl were becoming symptomatic/testing once already at peak virus load & transmission always coming down
But now ppl are becoming symptomatic day 1 & day 4,5 may now be when ppl still at peak infectiousness
2/
I’m 1000% on board with cutting down isolation as much as possible
Heck - most ppl who tested positive in this pandemic on PCR over the past 2 years were already no longer infectious by the time they started isolation. I have argued that those ppl required 0 days isolation
3/
@US_FDA’s remarkably vague (likely false) statement w ZERO supporting information that serves only to damage confidence in one of the best tools we have is insane
The data FDA offers is:
“early data suggests… rapid tests MAY have reduced sensitivity”
Because of this line - with no supporting information - effectively every major news outlet today has reported that rapid tests are less sensitive to detect Omicron.
But the actual data suggests otherwise. Omicron is not mutated where the tests detect.
2/
It’s a bit like saying
“I got plastic Surgery on my face”
and FDA says
“Oh, Your shoes may not fit you anymore”
The reality is the tests likely detect Omicron same as they did Delta… but Omicron is more infectious so any test will have a harder time picking up at first
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