qPCR is highly specific as a medical test to appropriately identify SARS-CoV2 RNA....
but qPCR is terribly NOT specific as a public health test to determine who should still be isolating (though looking at Ct values can help)
This is not good for public health.
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We never should have made qOCR the gold standard for evaluating public health tests. It was a mistake from the beginning bc as CDC readily says - you stay positive on a qPCR test for weeks after you are done transmitting. The specificity is terrible as a public health tool
3/
At the very least, we should recognize this when evaluating rapid Ag tests bc these tests are highly specific to detect only ppl who are still needing to isolate bc they are infectious.
The tests have different purposes
Remarkable that this conversation still has to happen
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It is true that Ag tests are not as sensitive as qPCR. Of course. But that’s always the tradeoff in medicine and public health. When something is too sensitive it often becomes non-specific. And when too specific it is often not as sensitive.
However...
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The many stories that Ag tests are only 30% or 40% sensitive compared to qPCR in asymptomatic people is driven largely (by a long shot) by qPCR lacking specificity for who needs to isolate, not Ag tests lacking sensitivity for those needing to isolate
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This is readily noted by recognizing that average person needs to isolate for 10 days. Meanwhile qPCR is positive for 20-30 days. It’s simple math.
10 d isolation / 25 days PCR pos = 40%
60% of time that qPCR is positive, we do NOT want or expect Ag test to be pos...
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We know that frequent accessible testing with rapid results can be a critically important tool to slow transmission, keep R<1 and prevent surging cases. Why? because anyone can be exposed to the virus and not realize it until after they have become infectious.
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I hope this new initiative will demonstrate the effectiveness of accessible, frequent at-home rapid testing and subsequently inform national policy to make at-home rapid testing available to all Americans without a prescription (and ideally for free!)
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Population-wide Rapid testing over a two week period of time (Rapid Ag testing of ~50% of population each weekend for two weekends in a row) PLUS subsequent quarantines led to ~70% reduction in prevalence.
Figure above shows the relative reduction in prevalence that occurred - which was consistently substantial across the regions where the population wide rapid testing was performed. Centering around 58%. Compared to what would have happened, the effect was even greater (70%)
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The authors used mathematical models to help understand if the effect noted was due solely to tests, solely to the isolation and quarantines imposed or to both.
They found very strong evidence that it was the overall program - the rapid testing PLUS the behavioral changes
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THREAD: Statement on new FDA guidelines for Screening programs
Today FDA announced new guidelines for screening programs (i.e. testing asymptomatic individuals frequently to detect positive cases before they spread to others). fda.gov/news-events/pr…
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While this appears to be good news and a positive step forward to increasing regular testing for public health, we still don’t have a full understanding of how to interpret these guidelines.
There are a few details that we are trying to get clarification on from the FDA.
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For Ex:
1) Does this allow schools to implement a screening program without a CLIA waiver or prescription? (both barriers to testing)
2) Will FDA designate previously approved tests for screening purposes or will the test developers need to apply for a screening claim?
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Today I am announcing a new massive public health research study - with @Citibank - to use and evaluate frequent at-home rapid testing. The study is evaluating how well workplace infections are prevented by frequent home-tests.
The study is evaluating whether rapid home-tests used ever M/W/F can successfully prevent workplace transmission better than current status quo of symptom screens and evaluates how well non-medical ppl can perform the tests on their own.
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The rapid tests - which aren’t yet EUA’d but are used globally and we’ve found to be very effective in pilots - are being introduced in conjunction with @LivePerson’s Bella Health app to provide AI-powered assistance to help people at home learn how to use the tests.
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Unfortunately, this fact, that when public health is working well, it is unnoticed, necessarily sets them up to appear like they are failing.
The only time the public thinks about successful public health efforts is when they falter at all, especially if faltering is rare.
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This happens all the time with the most successful vaccines... b/c the only time highly successful vaccines make the news (outside of a pandemic) is when a rare adverse event occurs. We simply don't report the constant daily successes of the best working programs.
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