Tuesday, February 16, 2021

Test snafu

Wouldn't it be nice if there were a $5 test that works in minutes, and can find asymptomatic people who might transmit covid? Imagine how many schools, businesses, restaurants, weddings, churches, and so forth could safely open with such a thing. Imagine how much the reproduction rate of the virus could be crushed. 

There is! And it's sitting on shelves, one of the biggest casualties of the US federal monopoly on this simplest of all consumer goods. From detailed Wall Street Journal coverage

“Antigen testing is one of the most powerful tools we have to hasten control to normalcy,” said Richard Pescatore, associate state medical director at the Delaware Department of Health and Social Services...

The tests can quickly help determine whether someone is infectious. The tests detect cases by searching for pieces of proteins from the virus. They deliver results in minutes.

Among the first rapid antigen tests cleared by regulators was the BinaxNOW, which is made by Abbott Laboratories, costs $5 and doesn’t require any equipment.

Costs $5 to the federal government. Imagine if Abbott could send it to you via Amazon or ship it in bulk to Wal Mart. Alas, rather than simply sell the tests on the open market, the federal government is the monopoly buyer, shipped them to states, and they sit on shelves: 

The U.S. government distributed millions of fast-acting tests for diagnosing coronavirus infections at the end of last year to help tamp down outbreaks in nursing homes and prisons and allow schools to reopen.

But some states haven’t used many of the tests, due to logistical hurdles and accuracy concerns, squandering a valuable tool for managing the pandemic. The first batches, shipped to states in September, are approaching their six-month expiration dates.

At least 32 million of the 142 million BinaxNOW rapid Covid-19 tests distributed by the U.S. government to states starting last year weren’t used as of early February, according to a Wall Street Journal review of their inventories.

The central problem remains conceptual, as I see it. You need a very accurate test to treat a sick patient. A much less accurate, but cheap and fast test is better to see who is contagious and stop the spread of the disease. This is a mental block that too many in the game can't seem to get over. 

Studies now suggest rapid antigen tests like BinaxNOW miss more cases than laboratory-based tests that take more time to work, but are able to detect the virus among people who are most infectious. That can help speed up contact-tracing and containment efforts.

Some epidemiologists describe them as “contagiousness tests.” They are also most effective when used repeatedly on the same population, according to health authorities.

What's stopping it up? 

Some state health officials said they were reluctant to use the tests for regular, continuous screening because they didn’t know whether they would get a continuing supply. Others were already using tests from other companies.

Some facilities such as schools haven’t used the tests because of the amount of training staff needed, regulatory waivers that facilities must have to use the tests, and the time it takes to manually report results.

Other states delayed using the tests as they built the technology needed to easily report the results to public-health authorities and trained school nurses, nursing home staff and others to administer them.

Virginia spent months training people to administer tests, ensuring facilities have clearance to use them and creating a system to report results, said Parham Jaberi, chief deputy health commissioner.

The state distributed 949,000 of the 2.24 million tests it received to hospitals and other sites, Dr. Jaberi said.

Because the tests are most useful in outbreak situations or when used repeatedly, some state health officials also say they have tried to keep a reserve on hand and space out distribution over time.

Clemens Hong, Los Angeles County’s co-lead of Covid-19 testing, said he aims to add more rapid testing soon because fast positive results are helpful for quicker contact tracing.

Yet he said he is concerned about the tests’ accuracy, which is why the county, during the surge in cases around the winter holidays, gave priority to broadening access to the lab-based tests that take longer to work. The county runs the rapid tests and lab-based tests simultaneously to confirm the results.

About half of the 11.9 million BinaxNOW tests sent to California have been used, according to the state.

 I quote at length so you can see the muddy thinking here. Good thing there wasn't an exponentially growing pandemic on so there was time for all this bureaucracy! 

The root problem: Bought by the federal government, given to states, given out by governments. The point of testing is to get the economy going. 

Really, would just allowing Abbott to sell the tests on the open market not have produced a 100 times better result? 


14 comments:

  1. If the test was approved by the FDA (presumably it was since Abbott can sell the test, at least to the federal government), what prevents Abbott from selling the test more broadly?

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    1. I believe the Federal government bought up the entirety of the first few months of production. Production is up to 50M tests per month now, initially slower. Even at 50M/month, the Fed's order of 150M would have been 3 months worth.

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  2. This is another example, of America's main problem how to have an effective government this is efficient enough to react in time to crisis situations. One of the significant causes of this problem was W Bush's dramatic expansion of politically appointed positions and general attack's on career bureaucrats - believe it or not I do think it takes time to understand how to make government work. Confusing laws - example I went to the DHS manager of the county food stamp program he showed a good sized bookcase - he said those are are laws and regulations covering food stamps. You can almost justify almost anything quoting one or more of those regulations. Because of situations like that you get the government responses noted in your article. Keep up the good work - we need to focus on real problems!

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  3. The test is available to the public for home use, at a price of $25. https://www.abbott.com/corpnewsroom/diagnostics-testing/new-at-home-covid-test.html

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    1. Finally! If anyone has successfully bought one let me know.

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    2. But why do you say "finally!"? The announcement of the availability of the test is dated December 16. You didn't do the minimum of fact checking. Admittedly, there could be catch. How about you complete your own research and report back.

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    3. Requires prescription and for *symptomatic* patients: https://www.fda.gov/media/144574/download

      Also, if you want to contradict Cochrane's (apparently true) claim that the federal government has blocked convenient at-home testing, it really falls on you to point to counterexamples: either show that people that are doing it or show that it could easily be done. It's actually doesn't fall on Cochrane to hunt down every false lead to show that they're false.

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    4. I registered, and was offered only a bundle of 6 kits for $150. No Rx required. Didn't order, because I have had 2 doses of Pfizer vaccine, the latest one 3 weeks ago. I might self-test soon, if I can find 5 people who want to do the same!

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    5. To BC (and to Dr. Cochrane): There is nothing at all in the quotes from the WSJ article (which detailed failures in the distribution and use of US government purchased rapid tests) supporting Dr. Cochrane's conclusion that the test was not also available for individual purchase. It took me only a couple of minutes of internet search to find that Abbott has been offering the test to the public since mid December. Since yesterday, I followed through and discovered (as did Anonymous) that the test is being offered in bundles of 6 at the price of $150 without prescription, but with the requirement that the purchaser checks off boxes reporting at least some symptoms. Maybe you are not satisfied with the conditions or the price, but this is not a false lead. What in my opinion is Dr. Cochrane's responsibility? Since he has taken on the role of reporter and commentator, with special insight derived from his economic expertise, at least basic fact checking of his own assertions, to the extent that he cannot quote a reliable source, is certainly required. I'm sorry, but it's kind of obvious that he didn't put in the least effort.

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    6. Forgot to add, related interesting news. The German minister of health has stated that rapid tests are to be available to all German citizens without cost beginning March 1, but at first only from qualified providers -- e.g. pharmacies-- and not as home tests.

      https://www.zeit.de/wissen/2021-02/corona-pandemie-schnelltest-jens-spahn-virus

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    7. Mr. Goodman.

      This is the second paragraph of the December 16th article you refer to. What part of "with a prescription through a virtually guided online service" did you find confusing? And you say that you bought it, but had to falsely claim you were symptomatic to be able to buy them.

      "Today we’re pleased to say that our widely-used BinaxNOW rapid test, the size of a credit card and requiring no instrumentation, has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for use at home with a prescription through a virtually guided online service."

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    8. I'm not sure what your point is Anon. I reported the exact conditions for purchase, for your information. I didn't say that I actually bought it, or that I made any false claims.

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  4. Still requires a prescription, based on the link above.

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  5. The FDA now (April 1, 2021) allows two rapid antigen tests for te novel Corona virus to be purchased over-the-counter (without prescription) at pharmacies for multiple serial testing at home. The news report from The Wall Street Journal is accessible to subscribers here:

    FDA Authorizes First Covid-19 Tests for Repeat, at-Home Screening https://www.wsj.com/articles/fda-authorizes-first-covid-19-tests-for-repeat-at-home-screening-11617296505

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