Home Covid Testing

[CaptTom]

This is all very encouraging, but I see a possible roadblock in the US. Can testing have a positive impact if only 50% of the people get it?

Right off the bat, 40% will refuse because they believe it will negatively impact their preferred candidate's chances in the election. I'm guessing another 10% (probably more) are simply too busy, too lazy or just unable to deal with the process of getting tested.

I could see it having a positive impact if workplaces and schools required - and performed - the testing before allowing employees and students in. That would at least create a safe "bubble" on company or school property. Maybe that's our best hope.

[audreyh1]

Quote:

Originally Posted by CaptTom I could see it having a positive impact if workplaces and schools required - and performed - the testing before allowing employees and students in. That would at least create a safe "bubble" on company or school property. Maybe that's our best hope.

Yes, I see that where rapid and cheap testing is most useful. To help keep places where people must gather as safe as possible.

Contact tracing too, as much as it can be done in this country. Lots of resistance to contract tracers, many people won’t cooperate from what I read.

[sengsational]

This is the virologist from Harvard that's championing the rapid antigen testing.

Starts in 10 minutes.

Not the 'live' means much when you can always watch the replay, hehe!

www.medcram.com/pages/live


Here's a link to a free NYT article penned my none other than our buddy Larry Kotlikoff! Larry is the guy who's famous for "won the game, why gamble" approach to retirement investing! Small world.

https://www.nytimes.com/2020/07/03/o...rus-tests.html

[sengsational]

If you think rapid tests are a good thing, you can visit here:

https://www.rapidtests.org

to learn more about how to support the idea.

[audreyh1]

Texas does not include rapid antigen tests positive results in its COVID-19 case counts.

Quote:

Texas, unlike 27 other states, excludes the results of increasingly popular, rapid COVID-19 tests from the numbers it reports publicly — obscuring the scope of the pandemic, records and interviews show. The antigen tests are used in doctor’s offices, hospitals and stand-alone clinics and deliver results in less than 30 minutes. ..... And while there is no way to independently estimate the scope of the undercount, based on the 11 Texas counties that publish antigen tests results separately of their own accord, the state’s tally is short by at least tens of thousands of cases — but likely far more, a Houston Chronicle analysis found. And the undercount is about to get worse. The federal government is rolling out a program to use thousands of antigen tests in nursing homes across the country — including Texas.

https://www.houstonchronicle.com/new...t-15452709.php

[sengsational]

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-...gislation/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

https://www.youtube.com/watch?v=3seIAs-73G8

[LRDave]

^^^^ Thanks for the summary sengsational! ^^^^

[sengsational]

Apparently, state governors are in a unique position in that if they choose to, they can bypass the FDA.

Why do that? Because the FDA is only allowing machine-read tests. Thus, the machine becomes the bottleneck. Especially because the machines can't be purchased and setup just anywhere...the location of the machines are regulated. So we can print millions of test strips cheaply, then can't process them quickly enough.

But a state governor can do an end around the FDA and let true home testing begin in earnest. That's a risk for a company producing the test, though. But I wonder if several state governors will get together and approach one of these companies. The problem is that the states can't print money like the feds can. But states can write guarantees, I suppose. Not my area of expertise, but seems logical that states could try to reduce the risk to the company making the investment by "signing something".

[sengsational]

There's more than one company that will jump into action when the laws allow it, but here's one, for example: https://medusa19.com/press.html

Quote:

The test being created by Avacta and its partners is intended to enable an individual with the COVID19 infection, whether they have symptoms or not, to be identified before antibodies have been generated by the body. Given this test will be saliva based, it could be used in airports, offices, factories and in the home environment, providing a result within minutes and with no requirement for medical supervision. It is potentially ground-breaking and a major step forward in the fight against COVID-19.

And in the 'truth is stranger than fiction' category, this life changing, earth shattering test is to be brought to you by the same people who brought you young person clothing site boohoo.com.

[sengsational]

MedCram released a 5 minute video that explains the basic concept, as related by Dr. Mina. This is a good one to give to those who don't have a lot of time to clear their confusion surrounding how a "less accurate" test could be light years better than a "more accurate" test when it comes to public health.

https://www.youtube.com/watch?v=AZWuyvBAWWQ

[donheff]

Good video

[sengsational]

Abbott got approval from the FDA for a test that is human-readable (no machine required). The cost is about $5 and it takes 15 minutes to get a response.

Still not a "Home Covid Test" because it requires a medical professional to administer the test, but we're getting closer to having a way to pull the most infectious people out of the population and prevent them from spreading the virus around.

[audreyh1]

Really glad that we are homing in on this quicker easier testing. Yes, quickly identifying the spreaders and getting them to isolate will help tremendously even without a vaccine available. Even if it’s just in workplace, school, medical and custodial care settings, it should make a big difference.

I hope more sewage testing is done too. That was very successful for quickly finding an infected dorm at University of Arizona.

[RonBoyd]

Quote:

Originally Posted by audreyh1 That was very successful for quickly finding an infected dorm at University of Arizona.

As at the University of Colorado.

[cbo111]

Back in July, I read that the FDA was going to allow companies to develop Covid test kits that could be done completely at home, to include getting test results. No need to mail it off. I cannot find anything on the web regarding any companies actually creating such tests.
I am very interested in purchasing test kits for a future visit to see the kids and grandkids. We have not visited any of them since January, and DW is going a bit crazy needing her in-person grandbaby fix. But she has asthma and is immune compromised, so we need to be extra careful. The kids work and grandkids are in school, so possible exposure is making us a bit squeamish to visit them. I would be happy to purchase all the kits that can quickly tell if anybody has the bug the day prior to us visiting. Does such a kit exist or is it just a pipe dream?

[Aerides]

There have been a few news pieces over the last couple of days. Not really so much about when, but that progress is being made.

https://www.axios.com/gauss-cellux-f...e5cf0f10c.html

This test looks like the closest to a consumer-near-real-time test kit. I would imagine it's at least a few months away, but there's probably a huge financial incentive to get these out there.

[Gumby]

Merged threads on this topic.

[Rianne]

Cost to the consumer will be the driver. How much will the govt. cover? How long will it take to develop and deliver to pharmacies or individuals. Right now, our university is using saliva tests. And it seems to be working for 50,000 students on campus, provided those tested positive will follow the rules. It's the best we have right now.



"To take the test, a person only needs to spit into a tube, then the sample is heated for 30 minutes and scientists add chemical reagents to prepare the sample for RT-qPCR. Each test costs $10. The school budgeted $6 million for startup costs and up to $10 million for testing throughout the semester. The initiative is supported by a cell phone app that immediately notifies individuals of their test results and can alert them if they’ve been in close contact with someone who has tested positive. Those who test positive are quarantined. Now, that plan is being put in place as school is getting underway."



https://www.the-scientist.com/news-o...-per-day-67890

[sengsational]

CBO, I'd suggest you read the whole thread, now that it's merged.


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.

[sengsational]

Quote:

Originally Posted by sengsational * E25 Bio has a working model, but the company has only 3 people! But they could change the course of the pandemic.

Here is an interview with Dr. Bobby Brooke Herrera, CEO of E25Bio, a company that has developed an "at home paper antigen test" for SarsCoV2.

The test would come with a Q-tip, which you swirl around in your nose (not the back of your throat), then you "rinse" the Q-tip in some special fluid that comes in a little "test tube" like thing. Finally, you drop a strip of paper into the little test tube thing. In 5 or 10 minutes, if you see two lines on the strip, you're positive and you then 1) isolate, and 2) implement whatever your "early Covid fighting protocol is" (if you have one).

The test consists of monoclonal antibodies that are specific to the SARS-CoV-2 spike glycoprotein antigen. The test is not cross-reactive with other coronavirus antigens or any known antigen except SARS-CoV-2. It uses traditional lateral flow technology on a paper strip.

You can not buy these tests today because the FDA has not approved the test, and no state governor has yet used (legal) executive powers to work around the FDA.

Unlike other conversations on the topic of home based testing which concentrate on the ability of such testing to reduce transmission in the community, the interviewer's (Dr. Mobeen Syed) questions center on how the test can be used to initiate early interventions that might be protective of getting more severe disease.

https://www.youtube.com/watch?v=XruCdghUqwg