An ongoing dialogue on HIV/AIDS, infectious diseases,
July 26th, 2020
Time to Amplify Our Voices Calling for Inexpensive Rapid Home Testing for COVID-19
Earlier this month, I highlighted how inexpensive rapid home testing for COVID-19 could get us out of this mess faster than a vaccine.
To spare you re-reading the whole thing, here are the main points.
Imagine a simple test done on a saliva sample placed on a paper strip. Results back in 15 minutes. Available without a doctor’s order. A couple of dollars per test. Would be as easy to perform as a home pregnancy test.
And, most importantly, the results will highly correlate with what we care about the most when testing a person without symptoms — are they infectious to others?
With testing applied broadly, and a negative test in hand, think of the implications!
Outpatient visits and procedures. Hospital visitors. Schools and universities. Air travel. Public transportation. Fitness clubs and gyms. Educational, business, and research conferences. Hair salons and barbershops. Bars and restaurants. Houses of worship. Nursing homes. Meat-packing plants, agricultural jobs, transit, and other high-risk work. Choral practices. Cruises. Homeless shelters. Dormitories and military barracks. Spectator sports. Prisons and jails.
Endless, really.
Prototypes for these tests, or slightly more complex versions, already exist. So what’s the hold-up?
Even though numerous companies and academic groups are working on such tests, there’s no guarantee the FDA will approve them — especially since they’re going to be less sensitive than the gold standard PCR tests we use for symptomatic people.
But this lack of sensitivity shouldn’t block availability, since the tests likely will be positive during the few days that people have the highest titers of virus in their respiratory tract, and hence are most contagious. The quantity of virus in this early period (as measured by cycle thresholds) often is millions-fold (or more) higher than just a week later. Rapid tests done regularly should be able to capture this period of exponential viral growth.
And a reasonably accurate test with results back quickly is far better than no test at all — or, as is sometimes happening, a test done with frustrating and potentially dangerous delays in results due to testing backlogs.
Hey @michaelmina_lab, this one's for you! h/t @boulware_dr @StarTribune SteveSack. pic.twitter.com/waA3PpKtAO
— Paul Sax (@PaulSaxMD) July 25, 2020
At this point I should note the major inspiration on this topic all along has been my brilliant colleague, Dr. Michael Mina, who has become a persuasive and passionate champion of the rapid home testing strategy. Here he and economics professor Laurence J. Kotlikoff advocate approving these tests and then making them available to everyone:
Once paper strips’ efficacy is definitively proved and they are cleared by the F.D.A., Congress can quickly authorize the production and distribution, for free, of a year’s supply to all Americans. Then we’ll have not only a true day-to-day sense of Covid-19’s path. We’ll also have a far better means to quickly contain and end this terrible plague.
Michael has been making the rounds pushing the idea, and fortunately, it’s starting to get a broader audience. I mention it often enough that my immediate family must wonder whether I’ve replaced my baseball obsession with a new one. (They may be right.)
And while I read with interest about how the NIH plans to rapidly scale up testing, the home testing component of the program gets scant mention.
Full disclosure, I have my own personal reasons for wanting easily available rapid tests — reasons that go beyond wanting to go out to a nice dinner, to start up my neighborhood poker game, or to visit Fenway for some baseball. Yes, those would all be nice.
New York City skyline, 1931
But mainly, it’s this — my parents live in New York City and have essentially been in full shutdown mode for months. The cultural activities of the city that so enriched their lives — movies, plays, operas, lectures, book clubs — have vanished. Even worse, they’ve had minimal non-Zoom contact with family or friends, including their children, grandchildren, or great-grandchildren.
Their life now isn’t great. But they grew up during the depression, lived through World War II, and as a result have maintained a cheerful perspective all along that takes into consideration how things could be so much worse. One of their friends, for example, had COVID-19 and is still recovering, months later. And they know that hundreds of thousands have died.
But now, my father needs major surgery. The hospital strictly limits visitors — one a day. And so the barrier to human contact — on our being able to visit and to comfort him safely — becomes more than just an inconvenience. It’s frankly heartbreaking.
So send good thoughts his way. He’s quite something, as I’ve mentioned.
Finally, take 17 minutes and watch this excellent video on the science and rationale behind rapid home testing — it draws heavily on a longer interview Michael did on This Week in Virology.
And if you have friends in powerful places, let’s push to make this potential breakthrough a reality — if not as national policy, can we do it at the state or city level? Because it can’t come soon enough.
25 Responses to “Time to Amplify Our Voices Calling for Inexpensive Rapid Home Testing for COVID-19”
Paul E. Sax, MD
Contributing Editor
NEJM Journal Watch
Infectious Diseases
Biography | Disclosures | Summaries
Learn more about HIV and ID Observations.
NEJM Journal Watch — Recent Infectious Disease Articles- Sulopenem Etzadroxil plus Probenecid (Orlynvah) for Uncomplicated Urinary Tract Infections
- Radiolabeled p-Aminobenzoic Acid as a Marker to Detect Bacterial Endocarditis
- Clostridioides difficile Vaccines: Promising Contenders
- Observations from ID and Beyond: Marking a Social Media Mass Migration — Until the Next One
- Incidence of Autoimmune Diseases Involving the Skin, After Acute COVID-19
So I loved the cartoon ,but with a rapid NEG test result on SUNDAY(15 min) she could still get infected on subsequent days even if she knew the results Sunday.
I can see where a rapid + result could lead to quarantine and reduced transmission,but if it’s neg ….So your at Fenway ,do you test everyone there,or do you believe the fans statement of negativity.
You would need a ton of test kits be able to do one everyday
I guess I’m missing something..help
Right on Paul. We can’t possibly maintain a long term suppression strategy without point of care testing infrastructure established in multiple locations.
I read Dr Mina’s article and He presents a very good argument on the narrow period of transmission and the trade off between sensitivity snd availability. we should get on it
Like you, I have become obsessed with this topic. My obsession began after hearing Michael Mina’s recent interview on TWiV.
Here are a few thoughts on how we might amplify the advocacy for this testing strategy:
– Get this covered by conservative media outlets, like Fox News
– Get the word out to business leaders. They should understand the positive impact this testing strategy could have on the economy
– Contact our senators/congressional representatives to explain
– Convince medical professional societies like the AMA and IDSA to endorse this strategy
Lastly, could the home test be marketed as a test of “contagious covid,” instead of a straight covid test? Maybe this reframing could help regulators and the public stop worrying about the comparison to the PCR test?
Thanks to you and Michael Mina for promoting this powerful idea. I hope your father’s surgery goes well.
Great idea!
This gives me hope…finally! I have felt from the beginning that the testing was being done too late to make a difference. This affordable and early option could save thousands of lives!
Much gratitude to all of you for promoting this option!
P.S. Need any subject for trials?!!
Not just conservative media is interested in getting word out and advocating for rapid tests available at home.
https://www.npr.org/sections/health-shots/2020/07/22/893931848/rapid-cheap-less-accurate-coronavirus-testing-has-a-place-scientists-say
This came 4 days before your post.
Best wishes to your Dad, Paul. I have recently experienced a parent hospitalized with critical illness during COVID 19 and it is quite challenging. The staff are indeed heroes even more than usual during this time. Agree wide spread testing is needed to get a handle on the pandemic. I hope your Dad get well soon and stay safe.
These concepts should not be new to us. I see a parallel to the situation with the PCR test for the C difficile toxin gene, which is so sensitive that many people with positive tests are carriers whose diarrhea is not due to C diff. Thus, many institutions now reflex all positive PCR tests for the C diff toxin gene to a rapid EIA test for the C diff toxin antigen and consider many people who are PCR+/EIA- to be carriers who do not require treatment. The irony, of course, is that the EIA test was derided for years for its poor sensitivity, but that property turns out to be the true strength of this test. The parallel with COVID-19 is not perfect in that C diff carriers who also have diarrhea (even if from another cause) are likely to be heavy shedders of C diff bacteria or spores into their environment, and — at our institution at least — are placed into contact isolation. Nonetheless, the key point is that the EIA test has low sensitivity only when the right question is not being asked: in the case of C diff the right question usually is whether C diff is likely to be causing the diarrhea and not just whether it is present. In the case of COVID, the right question is whether a person is likely to be infectious to others and not just whether viral genetic material can be detected in their secretions.
——————————
Michael Katzman, MD, FACP, FIDSA
Antimicrobial Stewardship Program
Penn State Health Milton S. Hershey Medical Center
Hershey, PA
——————————
Best wishes to your father, Paul. My own father had a different path to academic success. He enlisted when the war broke out, and soon learned that if he was an A student, the Army would pay for him to stay in college. Otherwise they would send him to France to get shot at by Nazis. He abruptly became an A student.
Your story is a reminder to all of us that visitors are very important. When they are restricted, it is critical that contact with the family be made at least daily, and this should be programmed into the system. I have had a family member at a hospital where most doctors would only speak to family if they were in the room during rounds (some would not even do that) – no phone calls – and this is just unacceptable in the COVID era.
Heard Dr Mina on TWIV and he is brilliant!
I have read the NYT opinion and your blog post and watched the video here. So generally do asymptomatic people who are contagious have CT values in the range that these tests can detect? I wasn’t sure if asymptomatic vs. symptomatic has any impact on CT levels. I am becoming increasingly convinced that tests like these are the future of reopening our schools which I desperately want for my own high school-age children.
People who never develop symptoms (but do have infection, but are truly asymptomatic) have lower amounts of virus (higher CT levels). It’s not clear they are playing much of a role in virus transmission.
The most useful aspect of this regular home testing is that it would pick up the presymptomatic people, many of whom have extremely high amounts of virus in the day before symptoms develop, and don’t know it. They are highly contagious in this period.
Read more here!
Paul
Thanks Paul. I have been hearing so much about high school students being likely to spread it among each other and then take it home – many of them without symptoms, or at least not noticeable symptoms. So just wondering if these tests can really allow high schools to open fully without fear of becoming super spreading venues, like happened at the high school in Jerusalem.
susanbshelton@yahoo.com
I have pushed for this for months–first hoping it might exist and then advocating for its development. I’ve written letters to the NYT, not published.
How do I advocate for these tests and how do i get them?
I’m a phsyciian but not one treating COVID cases.
Visit https://rapidtests.org ;
includes option to text your politicians (painlessley, allows you to review it before it’s sent)
and lots of resources.
If you’re on Facebook, a related group there is growing and sparking lots of discussion:
https://www.facebook.com/groups/590134215033774
There is so much enthusiasm. Let’s hope we can make change happen.
I really suggest everyone listen to This Week in Virology episode 640. There you can listen to a panel of professors of virology change their minds on testing after the interview with Michael Mina.
The antigen tests that the FDA has approved require a machine and the individual tests cost $10-20. These are being pushed out as point of care tests. They are fine. But they are not what we need to change the world.
As an idea of what is available now, India is selling Korean and Indian standalone (no machine needed) 15-30 minute antigen tests to hospitals and doctors for 450 rupees or $6. I looked at the specs of the Korean test and they didn’t seem much less sensitive than the antigen tests the FDA has given EUAs. This test is nicer than needed in terms of materials. If we go to a disposable vial you spit in, then drop in a test strip then the price should drop. Think of it as a urine dip test, replacing urine with spit.
School kids can do a test first thing each day in school with the teacher watching. If the less sensitive test misses a budding infection that isn’t infectious on Monday, it will pick up an infection that is infectious on Tuesday.
We also want some way for adults to prove that they have taken a test that day and it was negative, so that you won’t need a test everywhere you go, such as into a bar or restaurant. That’s a job for computer and privacy experts. Or if we could get the test down to a minute that might not be needed.
What is amazing to me is that there seems to be a world wide groupthink on what type of testing we need and that groupthink is wrong.
Dear Dr. Sax,
I am a microbiologist from Chile (a country with limited resources). We have been interested in rapid diagnosis since the pandemic arrived to South America. The only thing we had available at the beginning (as alternative to PCR) was antigen testing, so we investigated it (doi:https://doi.org/10.1016/j.ijid.2020.05.098) (we have a second paper in review). Our conclusions were:
1) antigen tests can be an alternative for rapid diagnosis if they are FIA (they give a fluorescent signal which is read by a POC instrument)
2) antigen tests work well when PCR Cts are 25 or less (first 5-7 days of symptoms)
3) Though manufacturers recommend the use of NP swab, we had good results working with the UTM left from the specimen used for PCR (published already).The tests with FDA EUA recently arrived to Chile, one of them even allows the use of UTM so we are planning to do a similar experiment with them.
The limitations of our experiments were that we used left-over specimens from symptomatic patients and that testing has to be done in the lab. However, it could be an alternative for rapid diagnosis in settings where the PCR is limited or it takes several days for the result.
Paul,
I could not agree more with this strategy, ideally with people doing home testing anytime they will be in public – even if every day — with free, publicly financed test kits for all. This initiative alone would save tens of thousands of lives.
Rapid at-home testing would enable disease-modifying therapy and intensive home monitoring of respiratory status to be started much earlier in the course of the illness.
Applied to LTC facility residents and staff, and residents’ relatives, it could make nursing homes and assisted living facilities much safer and allow family visits to resume without unacceptable risk.
Daily testing of students would make in-person education feasible without denial of the seriousness of COVID-19 in children, particularly those in middle school and high school.
Research, regulatory review and manufacturing of home coronavirus test kits deserves an immediate large investment. If necessary our legislators could return from their vacations to finance it.
Thanks for your much-needed advocacy of this essential part of a full solution to the pandemic.
I’m not aware of any rapid test that can distinguish between SARS-COV-2 and any one of the many coronavirus serotypes that cause common colds for which roughly 40% of the population are positive. How does anyone propose to
Mitigate the resulting confusion.
Verification will be hard. Will moms fib b/c they have to go to work & can’t take time off to take junior to a Dr.? What about workers? Show a negative strip at the door? No more sick days – get negative strip from a family member to show. Unfortunately, as the news shows daily, we’ve become a herd of stampeding ignoramuses rather than a cohesive society.
Then, will FDA approve? Imagine the headlines: “FDA approves test with only 80% accuracy!” And, if it’s cheap and self-administered, how will it support a huge bureaucracy? No, we have to have and expensive, politically defensible product, so lots of money can be made and bureaucrats feel secure. It’s okay – we’ll force insurance companies to cover it and then spread the cost through premiums/taxes.
Sorry.
There is a simple protocol that can be done anywhere without equipment and with off the shelf reagents. This protocol is applied directly to SARS-CoV-2 nose and throat swabs, with no RNA purification step required. Tested on over 180 suspected patients, and compared the results to those obtained using the standard method:
https://journals.sagepub.com/doi/pdf/10.1177/1535370220941819
I heard that there were platforms for generating automatic letters to governors, Senators or Congressional representatives. We need to put pressure on getting these rapid cheap test approved. Can anyone steer me to one of those?
https://rapidtests.org
has ready-to-review-and-send letters that can be sent painlessly in 2-3 minutes.
See also https://www.facebook.com/groups/590134215033774
How can i get the letter to send to governor requesting rapid testing?