Abbott Labs to the rescue? Free the tests!

Context: Cheap, fast, tests can stop this pandemic quickly, even if they are not very accurate.

Last week, Abbott Labs announced (more info here) that (finally)

the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its BinaxNOW™ COVID-19 Ag Card rapid test for detection of COVID-19 infection. Abbott will sell this test for $5. It is highly portable (about the size of a credit card), affordable and provides results in 15 minutes. BinaxNOW uses proven Abbott lateral flow technology, making it a reliable and familiar format for frequent mass testing through their healthcare provider. With no equipment required, the device will be an important tool to manage risk by quickly identifying infectious people so they don't spread the disease to others.  

Note the last sentence. Abbott gets it -- the point of this test is not to diagnose sick people, it is to keep most sick people from spreading the disease.  If every American got this test once a week for a month ($5 x $350 million = $7 billion = one drop in bucket of the fiscal and economic cost of this pandemic) it would be over in a month.

Abbott will also launch a complementary mobile app for iPhone and Android devices named NAVICA™. This first-of-its-kind app, available at no charge, will allow people who test negative to display a temporary digital health pass that is renewed each time a person is tested through their healthcare provider together with the date of the test result. Organizations will be able to view and verify the information on a mobile device to facilitate entry into facilities along with hand-washing, social distancing, enhanced cleaning and mask-wearing.

"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Robert B. Ford, president and chief executive officer...

Even better. (It does not say who the app reports data to, which could make it better yet. For example, it could automatically notify your employer.)

"With lab-based tests, you get excellent sensitivity but might have to wait days or longer to get the results. With a rapid antigen test, you get a result right away, getting infectious people off the streets and into quarantine so they don't spread the virus."

Again, Abbott gets it.

But, what's this business about "through their healthcare provider?"

Under FDA EUA, the BinaxNOW COVID-19 Ag Card is for use by healthcare professionals and can be used in point-of-care settings that are qualified to have the test performed and are operating under a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. Within these settings, the test can be performed by doctors, nurses, school nurses, medical assistants and technicians, pharmacists, employer occupational health specialists, and more with minimal training and a patient prescription.   

What is wrong with these people? (FDA) If most of us call our health care providers, you get  non-urgent appointment in about 3 weeks, insurance gets billed about $400, we pay $150, to get the necessary referral, and prescription (!) and on for more delays and costs to get the test.

What possible reason is there for all these restrictions? How can anybody be hurt by taking this test, and how will all these layers of bureaucracy help that anyway? Yes, a huge employer like Stanford can probably obtain a CLIA CoW, CoC, etc. and hire a "occupational health specialist" to administer tests, but how is a restaurant going to do it?

There is a pandemic on, folks. Regulators gotta regulate, I guess, to justify their existence. But not now.

Free the tests!


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