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My notes from Dr. Mina's interview. Please see the actual video if something doesn't make sense.
* One roadblock to rolling out the test is that US bureaucracy puts it in the realm of FDA because the results go directly to the test taker (outside of a laboratory).
* Sensitivity is very high for what we need to test for, and that's transmissibility.
* You don't sent out a fire truck out to every instance of lighting a match. The paper antigen test will detect a "house fire", and ignores the candle. True, there might be fire, but fire we care about, than needs attention, is the house fire.
* FDA has said that they're willing to do at-home testing, but what they expect is a test that meets lab test standards (90% of PCR gold standard). They also want special reporting (linked to the Internet). So the $1 testing company needs some infrastructure for reporting (but that's...) Reporting negative reports will probably not be followed through.
* K-cups machine analogy is where the FDA wants to go. But Dr. Mina says we need the instant coffee version. Nothing but a jar and hot water is needed. No machine, no IT infrastructure. We can do that fast and it will be effective.
* Dr. Mina though CMS/CLIA were going to be involved (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA)
* Elected officials are showing a sense of urgency and have been in touch with Dr. Mina. They might not understand the federal level complexities, though. Nobody wants to take liability if it turns out to work less well than expected.
* E25 Bio has a working model, but the company has only 3 people! But they could change the course of the pandemic. But huge companies, like 3M are in it, and they're excellent in getting products to market, and collaborating with MIT. Several companies want to go the K-cup machine model [requiring instruments], but those will take longer.
* Quidel got EUA approval, but requires a machine [requiring instrument]. Six states are going to buy these Quidel antigen tests, but the machines are the limiting factors. They are true diagnostics, so regulated by CLIA. So operators of these machines is limited. And insurance companies are involved, so it's the wrong direction.
* There might be a way to use your phone instead of the instrumentation machine to improve the sensitivity over just eyeballing the paper strip.
* "Lateral flow" is how these cheap paper test work (through monoclonal antibodies). This is not CRISPR based. Sherlock is trying to combine paper strip and CRSISPR based, and could possibly be low cost.
* RADx "shark tank" approach (with NIH) is a diagnostic test (not at home paper strip). So these need instruments.
* Dr. Mina wants to see 50 million tests a day, and that can't realistically be done with one of these diagnostic tests that require instruments.
* Abbot ID Now is as sensitive as PCR considering the main outcome (the study had very low Ct values). But we don't care about very low Ct values (above 40).
* Stop comparing sensitivity against a molecular test (looking for RNA). It's how many days of transmissibility does the test catch? The PCR test used infrequently is only about 5%, whereas the paper antigen test used often is over 90%.
* True, some people will slip through, but it offers partial protection. Super spreaders will almost certainly be prevented. Population prevalence will go way down, so the absolute risk will go way down (put on public health hat, and get out of diagnostic thinking).
* The test can not be sold under the rules of supplements and vitamins because it comes under CLIA (a standards body that offers licenses to operate). The test can be "CLIA waived" (like Abbot ID Now). So we need a "public health" route to be defined in the laws/rules.
* Pooling saliva is an option (yum!), so your whole quarenpod could spit and take an entire household action if it comes back positive.
* Saliva isn't Dr. Mina's favorite approach, and would rather have a Q-tip just inside the nose (not the painful nose to the throat). There's also an under the tongue to get more consistent results over just plain splitting.
* Labs are not allowed to report Ct (viral load), which is "bad" (the Ct value is good for contact screeners).
* Most Ct values of 37 are on the end of the infection and they aren't infectious at all, so no need to quarantine for 14 days. It's a waste of societal efficiency, and waste of contact tracer time if they got this test for the first time a few days ago.
* Advocacy groups are available, for instance, rapidtests.org. Animations are being built to explain rapid testing. There's a lot of momentum. This is as important as a vaccine.
* Dr. Mina is on the twitter: @michaelmina_lab
* One roadblock to rolling out the test is that US bureaucracy puts it in the realm of FDA because the results go directly to the test taker (outside of a laboratory).
* Sensitivity is very high for what we need to test for, and that's transmissibility.
* You don't sent out a fire truck out to every instance of lighting a match. The paper antigen test will detect a "house fire", and ignores the candle. True, there might be fire, but fire we care about, than needs attention, is the house fire.
* FDA has said that they're willing to do at-home testing, but what they expect is a test that meets lab test standards (90% of PCR gold standard). They also want special reporting (linked to the Internet). So the $1 testing company needs some infrastructure for reporting (but that's...) Reporting negative reports will probably not be followed through.
* K-cups machine analogy is where the FDA wants to go. But Dr. Mina says we need the instant coffee version. Nothing but a jar and hot water is needed. No machine, no IT infrastructure. We can do that fast and it will be effective.
* Dr. Mina though CMS/CLIA were going to be involved (https://www.cms.gov/Regulations-and-Guidance/Legislation/CLIA)
* Elected officials are showing a sense of urgency and have been in touch with Dr. Mina. They might not understand the federal level complexities, though. Nobody wants to take liability if it turns out to work less well than expected.
* E25 Bio has a working model, but the company has only 3 people! But they could change the course of the pandemic. But huge companies, like 3M are in it, and they're excellent in getting products to market, and collaborating with MIT. Several companies want to go the K-cup machine model [requiring instruments], but those will take longer.
* Quidel got EUA approval, but requires a machine [requiring instrument]. Six states are going to buy these Quidel antigen tests, but the machines are the limiting factors. They are true diagnostics, so regulated by CLIA. So operators of these machines is limited. And insurance companies are involved, so it's the wrong direction.
* There might be a way to use your phone instead of the instrumentation machine to improve the sensitivity over just eyeballing the paper strip.
* "Lateral flow" is how these cheap paper test work (through monoclonal antibodies). This is not CRISPR based. Sherlock is trying to combine paper strip and CRSISPR based, and could possibly be low cost.
* RADx "shark tank" approach (with NIH) is a diagnostic test (not at home paper strip). So these need instruments.
* Dr. Mina wants to see 50 million tests a day, and that can't realistically be done with one of these diagnostic tests that require instruments.
* Abbot ID Now is as sensitive as PCR considering the main outcome (the study had very low Ct values). But we don't care about very low Ct values (above 40).
* Stop comparing sensitivity against a molecular test (looking for RNA). It's how many days of transmissibility does the test catch? The PCR test used infrequently is only about 5%, whereas the paper antigen test used often is over 90%.
* True, some people will slip through, but it offers partial protection. Super spreaders will almost certainly be prevented. Population prevalence will go way down, so the absolute risk will go way down (put on public health hat, and get out of diagnostic thinking).
* The test can not be sold under the rules of supplements and vitamins because it comes under CLIA (a standards body that offers licenses to operate). The test can be "CLIA waived" (like Abbot ID Now). So we need a "public health" route to be defined in the laws/rules.
* Pooling saliva is an option (yum!), so your whole quarenpod could spit and take an entire household action if it comes back positive.
* Saliva isn't Dr. Mina's favorite approach, and would rather have a Q-tip just inside the nose (not the painful nose to the throat). There's also an under the tongue to get more consistent results over just plain splitting.
* Labs are not allowed to report Ct (viral load), which is "bad" (the Ct value is good for contact screeners).
* Most Ct values of 37 are on the end of the infection and they aren't infectious at all, so no need to quarantine for 14 days. It's a waste of societal efficiency, and waste of contact tracer time if they got this test for the first time a few days ago.
* Advocacy groups are available, for instance, rapidtests.org. Animations are being built to explain rapid testing. There's a lot of momentum. This is as important as a vaccine.
* Dr. Mina is on the twitter: @michaelmina_lab
