We know that high PCR Ct values (very low RNA) above 30 are generally not culturable/not likely contagious
For context, a Ct value of 30 is ~99.999% lower RNA than peak RNA when most contagious.
The Rapid tests in the study appear to have a limit of ~30
2/
So, even when virus is culturable at Ct 30, it is much lower amt than peak virus titers/when most transmissible.
Plus, Missing a Ct of 30+ is most likely missing someone AFTER peak viral load and not before Bc the time spent around 30-35 is much longer after than before.
3/
But the real issue with the study is that it is based on only 8 positive samples. 6 were 29-35. 2 were low or mid 20’s.
As expected, the rapid tests caught the high viral loads and didn’t catch the very low RNA loads. That we know were most likely late/post-infection.
4/
This is the whole point of rapid tests. Test frequently with rapid results to catch infectious people before they spread to others.
For public health screening, we are not trying to medically diagnose recent infections. We are trying to isolate contagious people.
5/
Overall, the paper described it in a fairly balanced way. Could have discussed more about what we know of high Cts and cultureability.
The numbers were too low and led to unstable estimates:
Ie sensitivity
100% w Ct <29
9% w Ct <= 29
Thus serious problems w sample size.
6/
Overall, results align with our expectations of rapid antigen tests. Even in this extremely limited study, they demonstrated similar results to many other studies & show again that these tests, when used frequently can potentially be very powerful tools to slow transmission.
7/7
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I feel frustrated to see me and my peers getting vaccinated ahead of essentially every high risk person on Earth.
We are generally low risk, have access to incredible healthcare, are mostly in upper echelons of wealth.
Incredible inequities.
Our systems are so broken.
When we proposed single dose vaccine trials - peers said it is unethical to give just single dose since we don’t know how it will work, in middle of pandemic
Unethical?? Ethics are global. Giving vaccines to the wealthiest, w access to PPE and least vulnerable first is unethical
(I did not actually sign up for my vaccine. But I could get it any time. Out of principle I will not get vaccinated first in line. It is not right for me to do so)
There is (rightly) concern about the variant SARS-CoV-2 strains. I want to talk about what this means for vaccines, our future, and why we MUST have contingency plans.
This thread is in response to many questions I've received.
1/24
First, Note: I'm not doing a deep dive on specific mutations. For that, see @angie_rasmussen@jbloom_lab@K_G_Andersen@BillHanage. I am an infectious disease immunologist / epidemiologist & study viruses/vaccines. So I'll speak from that perspective.
2/24
Second Note: I do not want this thread to be alarmist.
To put it upfront, the mutations thus far do not indicate a major evasion of immunity interfering w vaccines. However, the mutations should be a wake up call to action.
The rapid antigen tests caught all of the high viral load cases that were likely contagious and missed the low RNA level cases who were most likely beyond their contagious period.
This suggests the testing was simply too infrequent to catch the important cases.
2/x
At what point are we going to stop making the claim that these tests are too insensitive?
They are doing the job exactly as anticipated. Public health is not about diagnosing and isolating old COVID cases. It’s about identifying current contagious people.
3/3
That the test is being performed weekly is great. Perhaps people can order ahead. Still, with shipping, it will most likely be 3 days between the swab being used and result provided back. If it’s positive, that’s 3 days of walking around positive.
2/x
This is a good effort from Google.
But this sheds concrete light on the problems of delayed test results for an acute respiratory virus.
A 3 day wait erases ~50% of the EFFECTIVENESS of the test to stop transmission. A 6 day wait erases ~90% of the effectiveness
3/x
1) Regulatory - FDA must remove unnecessary regulatory requirements
Most crucial: ~90% sensitivity against PCR in ASYmptomatics w/out allowing a Ct cutoff
By time asymptomatics are found w PCR, Ct is >30 & post-infectious
1/x
@EpiEllie@mlipsitch@vivek_murthy By requiring demonstrating sensitivity specifically in asymptomatics, FDA is confusing EUA application with showing physiology of the virus.
Many studies show asymptomatics have virus.
The tests care about virus, not symptoms. FDA is confusing this point.
2/x
The study above, by @NiraPollock and others, is incredibly important because it proves that these tests do not care about your symptoms, they only care about the virus. And that they work in kids as well as adults.
The former issue is critically important...
2/
Currently @US_FDA requires that for these tests to be used at home OTC, they need to demonstrate explicitly that they work in asymptomatic people.
But this is completely unnecessarily burdensome - plus finding asymptomatic people shedding virus is very difficult!
3/