The US is at a critical point & we need greater access to faster tests
Rapid tests are barely available bc they're regulated here as MEDICAL tools-holding them back
Please write an EO that makes COVID testing in US a Public Health good
Thanks
Ppl of the USA
These tests are regulated by FDA as medical devices. Which has greatly limited them!
For pandemic control UNDER AN EUA FOR A PUBLIC HEALTH EMERGENCY, rapid tests should be regulated as critical public health tools, vetted (appropriately) by CDC/NIH.
I had the opportunity to speak to the prior administration about this. Unfortunately it didn't go far despite many ppl trying.
I hope that an administration as forward looking as yours (@POTUS ) would see the benefit of an executive order that stops this deadly silliness.
FDA holds public health tests to medical standards - requiring trials to compare Antigen tests to PCR since PCR is the "medical gold standard"
But it's not the "Public Health gold standard"... so the onerous requirements set by the FDA mean most companies can't enter.
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Rapid tests work very well to answer 🧵
AM I INFECTIOUS and a RISK TO OTHERS
This is THE public health ? we care about
I made a BIG chart of rapid tests
- Overall sensitivity vs any PCR pos - what FDA judges
- Sensitivity if infectious (97%!) - what we actually care about
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This data above comes from the UK COVID-19 Lateral Flow Oversight Team.
What the data above shows is that rapid tests are excellent public health tools to quickly identify almost anyone who is currently infectious and needs to isolate
What it also shows is...
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This shows why there is so much damn confusion about if rapid tests are sensitive
Answer: YES they are... if the question is "Am I Infectious Now and do I need to isolate"
However, if we compare them to PCR, then we are asking a different question: Do I have any RNA in me
3/
- Moderately infectious (ie infect 2 or 3 ppl in a classroom): 90-95%
- Mildly infectious (ie spread to spouse only) ~80-90%
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This Graph of viral load over time helps to explain this sensitivity issue:
Further, symptoms vs no symptoms has no impact on test performance. Studies that say it does are not recognizing the sampling bias that enters their studies.
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While I am tremendously happy to hear the President say this.
I do have my reservations:
Time is of the essence. If we start the scaling process now, it will take a long time.
Meanwhile many many tests exist globally. We could be using those for the time being.
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Importantly, I worry that the 280 million tests that are going to be purchased and produced with the use of the DPA... well, that's less than one test per person over the course of a year. The number sounds big but we do have 330 million ppl in US.
A test that is 100% accurate to detect infectious ppl will only *APPEAR* to be 30%-60% sensitive when compared to PCR-particularly asymptomatics
Why?
PCR stays positive LONG AFTER contagious period
for Public Health, PCR is NOT Specific - it’s a wrong comparison
Although rapid tests are not 100% sensitive to detect infectious levels of virus, they are >95% and do approach 100% for “superspreader” levels of virus.
We just (ignorantly) continue to compare them to PCR - which has led to massive confusion.
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This issue with PCR has caused us to isolate millions of ppl who were no longer infectious and lead contact tracers to trace and quarantine many many millions who were never exposed.
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With all the news of vaccines & immunity, did you know measles infections destroy immunity and cause “Immune Amnesia”, increasing risk of all other infections
Our research in ‘15 & ‘19 discovered this & the abbreviated story is written up nicely here:
In 2015, along w Bryan Grenfell and colleagues, we discovered an exceptionally strong relationship between measles epidemics and all cause childhood mortality - following outbreaks of measles, child mortality was increased for 2-3 years.
We hypothesized then that measles was destroying B cells and plasma cells responsible for retaining immune memory. This is bc the measles virus specifically attacks immune memory cells via attachment to CD150 - a protein enriched on memory cells.