Contamination at CDC lab was likely cause of early delays in rolling out coronavirus testing

[iluvtennis]

Contamination at CDC lab was likely cause of critical early delays in rolling out coronavirus testing
https://www.cnn.com/2020/04/18/politics/cdc-coronavirus-testing-contamination/index.html

Contamination in manufacturing the Centers for Disease Control and Prevention test for the coronavirus caused weeks of delays that slowed the US response to the pandemic, multiple health officials have told CNN, a problem that stemmed in part from the CDC not adhering to its own protocols, according to a US Food and Drug Administration spokesperson.

"CDC made its test in one of its laboratories, rather than in its manufacturing facilities," the FDA spokesperson told CNN on Saturday. "CDC did not manufacture its test consistent with its own protocol."

The government has never fully explained what stalled the rollout of a crucial test needed to begin measuring the extent of the spread of Covid-19. It would take until the end of February to correct and the US continues to lack extensive testing capability even as some states prepare ease up on restriction and reopen to a degree.

The Washington Post first reported details of the breakdown in the CDC's manufacturing of the tests.

In mid-February, the CDC was uncertain whether its test was malfunctioning due to a design issue or a manufacturing issue, two FDA officials said.

That was concerning to the FDA. On February 22, an FDA official traveled to Atlanta and spent the following days visiting CDC labs to try to sort out the testing problem.

According to an administration official, the FDA determined contamination was most likely occurring during the manufacturing process and that the CDC had appeared to have violated its own manufacturing protocols.

Within days -- by Feb. 27 -- the FDA and the CDC worked together to remanufacture the CDC test with the help of IDT, an outside manufacturer, according to administration officials. The remanufactured tests functioned correctly and were shipped to public health labs.

The FDA was simultaneously working with the CDC to allow public health labs to use the existing test kits with two of the three components, eliminating the third component that had been causing many of the tests to deliver inaccurate results, the two FDA officials said.

Two FDA officials and an administration official said there did not appear to be an issue with the design of the CDC test. The problem was the manufacturing process.

The FDA expert determined it was a manufacturing issue and worked with the CDC to facilitate the production and quality control processing of test kits made by one of its contract manufacturers -- IDT -- to expedite test kit distribution to public health and non-public health laboratories.

Read remaider at link above.

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trump/his folks knew about it and never told the American public. Yet, het gets on TV everyday to say that China wasn't transparent with us.

[SlimJimmy]

1. It sounds like the CDC screwed the pooch on this one

Am I missing something?

[Squinch]

2. AND we declined the tests offered to us by the WHO.

[iluvtennis]

3. Agree. Never made sense to me to not use the WHO tests. The rest of the world was using them. It

was about making money off of tests - i.e., the CDC test template would go to a company that trump crime family is invested in.

[Andy823]

4. The bottom line is

like it or not, trump is in charge, and responsible for those who work for him. He can make shit up, claim he is NOT responsible for any thing that happened, lie till his last breath, but in the end he is the one the screwed things up and he was the one that when golfing and had his insane rallies while things got worse! A really leader does not act like trump!

[Brainfodder]

5. More importantly! Do they have any bridges for sale?

[Igel]

6. In late February the news was quite clear.

There was a problem with one of the reagents. The news didn't say where the reagent was manufactured. That's the only new thing in the CNN report. The OP makes it sound like they're revealing something truly awesomely important for the first time.

I assumed that the CDC bungled things by not having proper quality controls in place for a reagent whose manufacture they outsourced. That it was made in-house revises that to "the CDC bungled things by not having proper quality controls in place for a reagent whose manufacture they conducted."

The part about the CDC's manufacture of the reagent wasn't included, but since everything else in the OP was widely reported on at the time I rate this claim as "trivially true":

The government has never fully explained what stalled the rollout of a crucial test needed to begin measuring the extent of the spread of Covid-19.

One could continue to make the same claim by revealing the dates of manufacture, batch numbers, name of the employees, and location--those aren't revealed so strictly speaking the government *still* hasn't "fully" explained what stalled the rollout. Unless it was a Trump or a Kushner or other political figure ...


https://globalbiodefense.com/2020/02/13/cdc-update-bumpy-roll-out-of-diagnostic-kits-due-to-faulty-reagent-sample-prioritization-mishap-delayed-covid-19-diagnosis/

https://thehill.com/changing-america/well-being/prevention-cures/485171-cdc-sends-updated-coronavirus-test-kits

[underpants]

7. Trump could have still rolled this to several manufacturers

When this is mentioned the first response should be "...AND?....What did they do about it?"