Home self-administered COVID-19 Tests Could Be the Answer to Reopening the U.S

[Cathoholic]

‘Instant Coffee’ COVID-19 Tests Could Be the Answer to Reopening the U.S.​

Cheap and quick, they could move us toward normalcy before a vaccine is widely available

By Carolyn Barber on August 21, 2020

. . . America is a country looking for an answer to COVID-19 yesterday. And one might be available—if you can handle instant coffee rather than espresso.

The coffee analogy is one used by Michael Mina, assistant professor of epidemiology at the Harvard T. H. Chan School of Public Health, and it’s meant to describe the functional difference between two approaches to rapid testing for the virus. In this case, easy and cheap — instant coffee, that is—may very well be better.

“This is the most important potential tool that could exist today,” Mina said in a recent interview. “We pretty much have a different way…to stop community transmission in the absence of a vaccine—and it is sitting right in front of us.”

. . . If you had the option to test yourself in the morning by spitting into a tube (or swabbing your nose) and waiting 15 minutes for the results, and if it cost you no more than a couple of dollars . . .

Mina breaks down the existing tests into two camps. “Espresso coffee” tests are reverse transcriptase polymerase chain reaction (RT-PCR) tests or deluxe antigen tests, . . . These tests are highly sensitive . . .

In sharp contrast lie the “instant coffee” rapid paper antigen tests. . . These are fast, simple to use, at-home tests, and some are really inexpensive: about $1 to $5 per test. They are called lateral flow assays, but manifestly they are paper-strip tests that have an antibody embedded on filter paper. If a saliva sample has coronavirus present, the antibody will bind that viral antigen, turning the test positive, much like a pregnancy test works. Though the tests have much lower sensitivity than PCR tests overall, one advantage they have is that they do not detect leftover, inactive viral RNA particles, which may be present days to weeks after a person is infectious.

Here’s the key: What is more important than a perfect test is one that turns positive during the time period in which an individual can spread the virus to others—and that’s, purportedly, what these cheap tests do well. . . .

. . . Mina believes their sensitivity and performance would far exceed that of a single PCR test. . . . public health surveillance depends much more on frequency of testing and rapid reporting of results than it does on the comparative sensitivity of the tests themselves. . . .

. . . we could very quickly get this pandemic under control. . . .

. . . Why haven’t we seen them in the drug stores? The answer is that the FDA is holding developers of these tests, like E25Bio, to the same high sensitivity standards as those required for molecular grade diagnostics. Without being granted an EUA, the companies are not manufacturing the tests. Mina and others argue that a paradigm shift is needed, so that rapid antigen tests are recognized as a “public health tool," . . .

Bold mine.

'Instant Coffee' COVID-19 Tests Could Be the Answer to Reopening the U.S. | Scientific American

 

[Pattylt]

I understand her point and actually agree with her but my Med Tech background gives me shivers.

The big word here is IF. If this testing was decided to go forward, what I would want to see is a ton of public service announcements showing exactly how to perform the test, where to purchase it, the amount and exactly what to do if positive with the caveat that a negative or positive may be false…and what to do if you question the result. Better still, what one should do if it is positive…STAY HOME.

I haven’t seen what the stats are on the test they are talking about but regardless, they aren’t as accurate. As long as they aren’t wildly inaccurate, that’s ok. We just need to know.

And again…step by step…how to correctly self test. I’d even love it if the government would supply this test to everyone. The cost would be more than worth it. If we could possibly test everyone tomorrow and immediately isolate all the positives, we could reduce infections in huge numbers.

 

[Cathoholic]

Nice post PattyIt. It is not a her though. It is Michael Mina. (Unless you are referring to the author, Dr. Carolyn Barber?)

Better still, what one should do if it is positive…STAY HOME.

They said this too in the op article.

I had in in there but I think I had to cut it out and remove the links to get the post to fit.

You and I were talking about this home-testing paradigm about six months ago. (Yes it would not replace clinic/hospital lab testing. Just like home pregnancy tests are still going to be verified by more sophisticated in-office testing too.)

This would be a great advance I think.

Why?

Because it would actually give us immediate knowledge of a real viral infection.

Right now when you go to the doctor you often get told, “It’s a bug. Go home and get better.” (Influenza is sometimes the exception and RSV with babies.)

But if this becomes widespread people will want to know WHICH virus they have.

Then when we know that from expanded viral testing, more therapeutics will emerge in my opinion.

The other obvious advantage is just what you mentioned. Isolation of sick people (instead of isolation of healthy people like we are trying now) at early stages of disease.

 

[Zzyzx_Road]

I remember something about this several months ago. There was some small company that was gearing up to market self test kits for Covid-19 and sell them at cost. But then it went quiet and we’ve all forgotten about it. But it turned out that test was sample at home then mail it to a lab. Not any more efficient than what is happening now at testing centers.

Given that it takes two days for most test results to be returned when they really should be made available that day within a few hours and then treatment can be targeted at those who test positive and already have symptoms.

Plus the standard tests carry a wholesale cost of about $100 per test. In the volume they’re being used, that is not at all cheap. So I’m all for cheaper alternatives where, like pregnancy, people can test themselves, get results quickly then see about medical care.

 

[Cathoholic]

Zzyzx_Road . . .

So I’m all for cheaper alternatives where, like pregnancy, people can test themselves, get results quickly then see about medical care.

Yes, you bet.

I am too. I would like to be in a situation where you can order a dozen or so tests from Amazon, keep them in your medicine cabinet, and check yourself anytime you think it would be appropriate.

A public information campaign by the Government would help into this transition of a new way for society to battle viral infections.

. . . If you had the option to test yourself in the morning by spitting into a tube (or swabbing your nose) and waiting 15 minutes for the results, and if it cost you no more than a couple of dollars, wouldn’t you jump at that chance? . . .

. . . the “instant coffee” rapid paper antigen tests, including one made by E25Bio, and one under development by 3M and MIT. These are fast, simple to use, at-home tests, and some are really inexpensive: about $1 to $5 per test. They are called lateral flow assays, but manifestly they are paper-strip tests that have an antibody embedded on filter paper. If a saliva sample has coronavirus present, the antibody will bind that viral antigen, turning the test positive, much like a pregnancy test works. Though the tests have much lower sensitivity than PCR tests overall, one advantage they have is that they do not detect leftover, inactive viral RNA particles, which may be present days to weeks after a person is infectious. . . .

 

[ThinkingSapien]

I understand her point and actually agree with her but my Med Tech background gives me shivers.

My sister works in a bio lab of some type. I’ve heard her mention complaints before from her policing lab workers that otherwise are about to do something that could contaminate a lab test. My expectations of the general public in reliably performing a test are even lower.

what to do if positive with the caveat that a negative or positive may be false…

Unless the patient self testing can achieve a high reliability than it may be if little value. A test result that says “you may be infected…but you might not be” is uninformative.

 

[Cathoholic]

ThinkingSapien . . .

My expectations of the general public in reliably performing a test are even lower.

I believe you.

Are your expectations of people this low
for home pregnancy tests too?

A test result that says “you may be infected…but you might not be” is uninformative.

They are not “uninformative”.

All tests have false positives and false negatives.
Even the tests that will be used for confirmation in the clinic
(that likewise are not “uninformative” either).

 

[Pattylt]

Unless the patient self testing can achieve a high reliability than it may be if little value. A test result that says “you may be infected…but you might not be” is uninformative.

Honestly, every lab test in existence has errors…most often from performing the test incorrectly but also the fact that no lab test is perfect. As a Med Tech we know this and always keep it in mind. You’d be surprised how often we repeat tests to confirm a result that doesn’t match what we’d expect before the doctor ever sees it…plus, doctors themselves often request we repeat a test…which we do.

This is why, if a self performed test does become available to the public there needs to be PSAs all over the media explaining exactly how to perform the test accurately. Believe it or not, most people really do perform home tests correctly…but, not all of them!

Personally, I believe that if a self test is reliable enough, it could be a huge advantage on getting a handle on the virus. Once again, not perfect but if even 50% of active cases know their status and isolate, that’s a huge reduction in spread.

 

[ThinkingSapien]

You’d be surprised how often we repeat tests to confirm a result that doesn’t match what we’d expect before the doctor ever sees it…

If the home test does achieve some reliability threshold, then I hope that there would be another test for confirmation performed in a lab. A single self-test alone might not make a good source of truth.

 

[Pattylt]

That’s a good point to consider. It depends on what would be expected from a positive result. Anyone requiring admission to the hospital should definitely have it validated with another method. However, if the expectation is just to self isolate for 14 days, then it’s a matter of employers accepting it as valid enough. That would probably be a company by company decision for employees actually working side by side with others or in direct contact with others. I would hope the business community would get behind it.

Initially, not much else needs to be done if someone is asymptomatic other than isolation. Self monitoring any possible symptoms and perhaps notifying your doctor that you tested positive. One’s doctor could certainly order a confirmatory test if necessary.

In a way, it’s like a home pregnancy test. If positive, one usually just calls the doctor and the doctor takes it from there.

One “side effect” could be some demanding to be prescribed HCQ. Since it takes a prescription, they would have to be in touch with their doctor anyway.

Worse case scenario is someone takes two weeks off work for a false positive. While a bit of a financial strain, I can’t see any other downside to the test. Am I missing something?

 

[RidgeSprinter]

That’s a good point to consider. It depends on what would be expected from a positive result. Anyone requiring admission to the hospital should definitely have it validated with another method. However, if the expectation is just to self isolate for 14 days, then it’s a matter of employers accepting it as valid enough. That would probably be a company by company decision for employees actually working side by side with others or in direct contact with others. I would hope the business community would get behind it.

My Director wants to see a copy of the Clinic’s report.

 

[ThinkingSapien]

Worse case scenario is someone takes two weeks off work for a false positive. While a bit of a financial strain, I can’t see any other downside to the test. Am I missing something?

I can’t think of any.

An unrelated pondering I have, how do people cohabitation together deal with a positive family member? Some of my family got lucky. A family member that tested positive was out of town when he fell ill. His employer paid for the hotel he stayed in. Had he been at home when he were I’ll then quarantining away from the fam is something they would have to figure out on their own. An element that leads back to multiple confirmations is his employer responded with quarantine after one positive test, but required two consecutive negative tests before returning to work.

 

[Pattylt]

My Director wants to see a copy of the Clinic’s report.

That’s because right now every test is performed by a lab somewhere and has a paper trail. If home testing became available and the expectations changed…? If even local governments promoted the self testing and requested that businesses get behind it and encouraged their employees to self test, that would be ideal. The businesses would hopefully require any positives to isolate. If businesses continued to demand letters from testing facilities to verify positives…that would create a situation where the infected would have to get a confirmatory test. Not ideal at all but still could be done I suppose. Especially if there could be a fast track for the positives. I sure don’t have all the answers…we don’t even have home tests yet nor do I have any idea of the stats for those in development.

I’m certainly interested in their specificity and selectivity as that makes a huge difference in whether it’s a good idea or not.

 

[Pattylt]

An unrelated pondering I have, how do people cohabitation together deal with a positive family member?

We are in this situation. My daughter and two grandkids live half time with us and the kids go to dads the other half. We had the discussion about what to do if someone of us were positive. All we could do is put a hold on the kids switching for two weeks…wherever they were when one became positive is where they would stay…but, most likely all of us were exposed anyway!

My daughter and her fiancé get tested about once a month as he is a liver transplant and she is his primary caregiver even though she lives with us. None of the rest of us have ever been tested as no one has had any symptoms. But, we are very aware that if we do, no matter how mild, we will get tested immediately and self isolate until we know.

Ours is a case where a home test would be very helpful as a screening tool…which is basically what any home test is…for screening purposes.

 

[LeafByNiggle]

The problem I see with the premise of the opinion expressed in the OP is that it mixes a private decision with a public decision. The decision to “reopen the country” (which is a misnomer itself, since the country is already mostly open) is a public one, since it deals with public policy. But the decision to take a home-administered test is a private decision. We have no idea how many people are going to go to the bother of testing themselves frequently - certainly not enough of an idea on which to base a public policy of, say, having normal face-to-face schooling. Just because a home test for covid is available does not mean people are going to use it.

 

[Cathoholic]

ThinkingSapien . . .

If the home test does achieve some reliability threshold, then I hope that there would be another test for confirmation performed in a lab. A single self-test alone might not make a good source of truth.

That is a very reasonable point ThinkingSapien.

The home lateral flow assay test, once positive, could be confirmed by your doctor who would do the PCR test (at least right now) for this confirmation.

The same if a sick person at home thought his/her test was falsely negative, could approach their clinic about a PCR test (which would likely also include a test for influenza as well – also useful clinically).

 

[Cathoholic]

LeafByNiggle . . .

Just because a home test for covid is available does not mean people are going to use it.

Yes. The article admits that fact.

But even so, that would be where the public relations campaign could help.

And contact identification (you may be able to even do contact I.D. privately to a certain extent) at least theoretically could be done sooner, keeping the “islands of virus infection” around the country smaller while that local recovery occurs.

By the way. I would like to see influenza added to this home-viral-test paradigm too.

There are probably more life-years lost from influenza than from corona virus as the average age of death with or without Corona virus is virtually identical.

Influenza is much more deadly for most otherwise healthy young people.

This is from March and has changed (children since, HAVE died from Corona virus too. Not just influenza virus) . . .

Coronavirus has spared American children. The flu has killed 144 kids so far this season.​

BY STEPHEN SMITH

MARCH 16, 2020 / 9:31 AM / CBS NEWS

. . . However, U.S. health officials say a relatively small percentage of children have tested positive for COVID-19 and those who have it tend to show milder symptoms. No child deaths have yet been reported.

By comparison, 36 million Americans have gotten the flu this season and about 22,000 have died. Children have been more vulnerable than years past with 144 pediatric deaths reported, according to the latest statistics from the CDC. Eight more child deaths were reported this week.

The figures underline a recent trend — while COVID-19 has largely spared children since its December outbreak in China, the flu has proven particularly devastating for kids in America this season. . . .

Coronavirus has largely spared U.S. children. The flu has killed 144 so far this season. - CBS News

 

[LeafByNiggle]

LeafByNiggle . . .

Just because a home test for covid is available does not mean people are going to use it.

That might work. But then we would need a way of measuring the effectiveness of that public relations campaign. If a poll or survey or whatever shows that a sufficient fraction of the population is following the advice of that campaign and testing themselves frequently, then and only then we might consider using that fact to inform public policy and relax some of the restrictions. I am more confident that a home test can be made available than I am that large numbers of people will buy it and use it enough to make a difference.

And contact identification (you may be able to even do contact I.D. privately to a certain extent) at least theoretically could be done sooner, keeping the “islands of virus infection” around the country smaller while that local recovery occurs.

That is a very important goal. Perhaps we could subsidize the tests themselves as part of the public relations campaign. Faster testing is way more valuable than testing with a long wait time for results as far as contact tracing goes.

 

[Cathoholic]

LeafByNiggle… . .

Perhaps we could subsidize the tests themselves

I am all for private subsidies.

Government subsidies tend to grow “strings” attached and get out of hand in other ways.

(i.e. “Hey I got an idea! Let’s as Government, subsidize rhinovirus testing too. And let’s tell the test makers they need an additional government certification if they want in on the subsidies. Annually. And we can set up a bureaucracy to oversee these new certification givers too! And let’s destroy the impetus to make the tests by telling private Industry we will only reimburse them if they charge such and such for a test in effect curtailing profitability!” etc. etc.)