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WP: “Inside the coronavirus testing failure: Alarm and Dismay among the scientists who sought to help” (a brief summary below)

2020-04-03

(sars-cov-2 viruses budding from epithelial cells in culture –electron micrograph from NIAID via Medscape.com)

This evening the Washington Post dropped a long article explaining how the US failed to produce virus testing kits in time and/or in quantity for our pandemic.  It makes for deeply tragic reading.

The first step was when Chinese researchers published the virus’ genetic sequence on January 10.  With the code in hand, virologists at the Centers for Disease Control (CDC) were able to develop a specific test which identified the virus.  They accomplished this in a week– record time.  Then they had to produce test kits to distribute to local public health laboratories around the country.  That is where an error slipped in, and one of the chemical reagents used in the production version turned out to cause errors in the results.

With the version of the test created at the central lab, the first patient in the US was identified.  This 35 year old man re-entered Washington State on January 15 after visiting relatives in Wuhan.  When he fell ill, he remembered seeing notices about a new virus in China and told his doctors that he might have it.  They ordered a test and confirmed on January 20 that he was infected with SARS-COV-2 (Severe Acute Respiratory Syndrome Coronavirus Type 2) and was suffering from COVID (COronaVIrus Disease).  He was treated with remdesivir and recovered.  His case was reported in the New England Journal of Medicine online on January 31.

Before the US could mass-produce a test, the World Health Organization (WHO) made one that worked and distributed 250,000 test kits to 70 labs worldwide.  The CDC created their own test and decided to produce it in quantity for US labs rather than depend on the WHO test.  They scaled up the test they were using and made kits that were distributed to state and county public health laboratories.  That is when the problem developed.  At the same time, university and private commercial laboratories were rushing to develop tests of their own and bring them to market.

The labs that had to use the mass-produced test discovered that they were getting wrong results on February 8.  On January 31, the Health and Human Services (HHS) Secretary had announced a public health emergency– the very next day after WHO declared the same.  This declaration by HHS is supposed to give the Food and Drug Administration (FDA) flexibility to speed approvals for critical supplies, including commercial diagnostic tests.  When the declaration was put into effect, it made the CDC test, which was approved on February 4, the only legal test in the US.

The declaration also created red tape for government-certified clinical labs at universities and hospitals.  Under normal circumstances, such labs are allowed to create their own tests without FDA interference as long as they use them only in their own centers and do not sell them.  When a public health emergency is declared, an Emergency Use Authorization (EUA) is required of them as an additional step to ensure the quality of the tests.

This EUA is a nasty piece of red tape, with which the lab scientists were not familiar.  They struggled with the test produced by the CDC and made it work, but they weren’t allowed to use it until they applied for and received the EUA.  One lab director described the EUA process as “flawed, broken, and inefficient” because it did not allow the local labs to modify the approved test they were given to make it work, and they could not proceed until they had filled out mounds of paperwork.

By February 12, the US had completed a total of 2,009 tests, all at the central laboratory.  Samples which were taken locally had to be shipped to the central CDC offices for processing, which introduced a delay of several days.  In the meantime, South Korea began to test 1,000 people a day.  The WHO test was available to US researchers, but legally could not be used to give clinical test results for individual patients because an EUA had not been done.  It was used only for research.  WHO officials said that the US did not discuss using their test (or ask them for help).

Weeks were lost in filling out EUA forms and waiting for bureaucrats to approve them. Five people at Mayo clinic worked 15 hour days for three weeks to get the data and paperwork that the FDA demanded for the EUA.  On February 24, the Association of Public Health laboratories submitted a formal request for the FDA to loosen the EUA rules.  By February 27, the famous Anthony S. Fauci became involved.  On February 29, the FDA allowed clinical laboratories outside the CDC to begin using any test for the virus without the paperwork, and said that they could submit papers within fifteen days after starting.

On March 2, the University of Washington began testing and within a few days was performing 2,800 tests a day.  Within two weeks, Roche and Thermo Fisher Scientific (two of the bigger laboratory manufacturers) won approval for their tests.  By the middle of March, there were 2,000 confirmed cases in the US.  As of yesterday, there are over a quarter of a million confirmed COVID cases.

Dr. Fauci is the head of the National Institute of Allergy and Infectious Diseases, a position he has held for many years.  On March 12, he told Congress in person that the coronavirus testing system was “a failure”.

One Comment leave one →
  1. Vicki Seitz permalink
    2020-04-04 12:36 PM

    I’m not normally one who grouses about “government bureaucrats”, but this really gives meat to the bones of the stereotype doesn’t it! What a devastating story! My heart goes out to all those affected by this idiocy, including my fellow paper filler-outer types at Mayo who labored insanely to get this stupid paperwork done.

    Nice reporting! I had wondered what on earth happened.
    Thank whatever powers that be for Dr. Fauci!! A grownup at the wheel!

    Like

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