Rapid at-home Covid tests are about to become much more widely available, the F.D.A. says.

[BumRushDaShow]

Source: New York Times

Rapid at-home Covid-19 testing is about to become much more widely available in the United States, the Food and Drug Administration says, following authorization of a mass-produced testing kit.

Competing at-home tests have been on the market for months, but Acon Laboratories’ test, authorized by the agency on Monday, “is expected to double rapid at-home testing capacity in the U.S. over the next several weeks,” Dr. Jeffrey E. Shuren, the director of the F.D.A.’s Center for Devices and Radiological Health, said in a statement.

“By year’s end, the manufacturer plans to produce more than 100 million tests per month, and this number will rise to 200 million per month by February 2022,” he said. Like tests already available from Abbott, Quidel, Becton Dickinson and other makers, Acon’s test is made to detect antigens, proteins from the coronavirus, on a nasal swab, and produces results in 15 minutes.

Such tests, which cost as little as $10, are not as sensitive as P.C.R. tests, which replicate the virus’s genetic material and are performed in labs. As a result, experts recommend that users carefully follow instructions and test themselves more than once, rather than trust what might be a false negative result.

Read more: https://www.nytimes.com/live/2021/10/05/world/covid-vaccine-cases/rapid-at-home-covid-tests-are-about-to-become-much-more-widely-available-the-fda-says

---

I had heard last night that Acon's test was recently approved for an EUA. I think the one that is most out there in the chain pharmacies - Abbott's BinaxNOW - has been in perpetual "sold out" mode ever since they had closed down their manufacturing and destroyed their inventory in the spring and now have had to restart production.

[gab13by13]

1. I don't trust the Abbott rapid test,

was baby sitting my grandson who got Covid in school, he tested positive with the PCR test, my daughter tested positive with the PCR test, I tested negative with the Abbott test but I have felt crappy. I interacted pretty closely with my grandson, like blowing his nose. I know I have antibodies because I had that tested with my routine blood work. My oxygen level is good and I can smell but I have something and it isn't the flu because the Abbott test said I was negative for that too. I had my 2nd dose of Moderna on March 23rd so that's over 6 months ago.

What good are these unreliable tests if to be sure one needs to get the PCR test? I can't go golfing because I golf with an 88 year old and I don't want to give him anything. My daughter needs me to babysit again in a couple days. Once Covid hits the schools it spreads, my grandson goes to a school that masks, even on the bus. Grandson feels great luckily. Covid isn't done yet at least for me.

[BumRushDaShow]

3. I don't think any of the hundreds of tests on the list

are "fully approved" yet - they are only approved under an EUA. They are just "screening" tests.

The PCR test takes time and lab tech personnel are limited, so if you look at the scenarios of getting a "positive" on one of the screening tests, even if it is a "false positive", it pretty much directs that person to pull away and quarantine until confirmed by PCR in case the screening test was correct, and they are still infectious.

However some of the tests might have a high propensity for a "false negative" (not sensitive enough or has a low specificity) and those are more concerning because the person could still be "positive" and infecting people unless they are really exhibiting the more moderate symptoms and choose to self-isolate.

The hope is to have enough data to weed out those tests that produce false negatives.

[bucolic_frolic]

2. What this country and the world has spent on this pandemic

Got vaxxed again, they had seating for recovery, everything was taped off. This is not like police tape you see, this is industrial stuff. 5" tall, plastic paper-backed, adhesive rolls. I couldn't even tear the stuff. They just apply it everywhere, doors, chairs, aisles - and more 6 ft distancing guides on the floors. Plus the personnel to set it up. The shot was a monster needle compared to last time. It hurt, and swelled for 5 days. They must use any available needle supplies.

[left-of-center2012]

4. "tests, which cost as little as $10, are not as sensitive as P.C.R. tests"

Quest Labs, which is where my doctor sends me for lab work, sent me an email saying I could get a COVID P.C.R. test for $68.
They have a doctor who will OK the test.

I'm guessing if my primary care doctor ordered it, my insurance would pay. Although it may not be a P.C.R. test.

[BumRushDaShow]

5. Well there are different types of PCR testing going on

--the ones where a county sets up "testing sites" with medical/lab tech personnel who swab you to collect the sample and then they drop those samples off to the contracted labs.

Then there are the "self-swab" ("at home" ) types - some that are nasal and I think others that are saliva, and those can be shipped by you to the testing lab (vs actually going to one of those labs to have them do the swab and analysis). For example this - https://www.pixel.labcorp.com/at-home-test-kits/covid-19-test-home-collection-kit

The cost differential might have to do with "in-person" vs "home-collected and shipped" and those that claim to be PCR should be PCR analyzed vs the "rapid tests" that you would actually see the results from (probably as some sort of color change).

[left-of-center2012]

6. The one I referenced are done at the lab n/t

[BumRushDaShow]

7. Okay

That's not too bad. I think I've heard prices as high as $150. But if they say "PCR" then it has to be done as a PCR vs a "rapid test" or they can be cited however that is done...

[left-of-center2012]

8. Quest isn't just some neighborhood shop

Quest Diagnostics is a Fortune 500 company.
Quest maintains collaborative agreements with various hospitals and clinics across the globe.

As of 2020 the company had approximately 48,000 employees, and generated more than $7.7 billion in revenue in 2019.

The company offers access to diagnostic testing services for cancer, cardiovascular disease, infectious disease, neurological disorders, COVID-19 and employment and court ordered drug testing.

[BumRushDaShow]

9. I have been using Quest Diagnostics for the past 10 years for my regular annual lab tests

[Quakerfriend]

10. My experience with the rapid tests is that you actually get a lot of false positives

I would estimate > 30%.

Last year, our protocol was, if anyone in the nursing home tested positive we would then sweep through and test every resident on that floor using the rapid test.

The residents who tested positive would then be transferred to our attached hospital and placed on a COVID floor where they were given a PCR test and awaited the results.

There were MANY false positives (rapid test) who tested negative on two successive PCR tests.

I had one lovely 98 year old who was very demented, but mobile, who refused to wear a mask or stay in her room while on the COVID floor. She kept coming out and telling us she was ready to go home, ie, back to the nursing home floor. She had had a false positive on a rapid test, followed by two negative PCRs.

So, she never got COVID but, this exposed her to greater risk.
Several days later she was happy to be back on the floor where she lived.

[BumRushDaShow]

11. One of my sisters

went through that ordeal last week. Positive rapid test followed by a negative PCR, where they concluded that meant "inconclusive" so she got a 2nd PCR that was also negative. Her daughter had been out sick for a few days and tested negative for the rapid test but went on and got a PCR to be sure and tested negative. So that is when my sis and BIL got tested around that same time just in case (where BIL was negative for the rapid test but sis was positive for the rapid test - and since she has RA and is immuno-compromised, there was an obvious concern). They were fully vaccinated this past spring and my niece was too, as soon as her age group was eligible over the summer.

The one issue with Delta however is that it infects rapidly, reproduces large quantities of itself in a shorter period of time compared to past variants, but then "disappears" rapidly too, again when compared to previous variants. So I think in some cases, depending on the timing of the rapid test before someone eventually gets the PCR, any possible infection may have already dropped below the threshold for a PCR to capture.