CDC is looking like amateur hour.
https://www.statnews.com/2020/02/27/a-single-...s-unknown/
As her condition worsened — she is on a ventilator — health officials in California asked the CDC to test her for the virus. Because she had not been to China and had not been a contact of a known case, the agency said no.
Eventually, more than 10 days after she went into hospital, the CDC agreed she could be tested. Dozens of health workers who may have come into contact with her at NorthBay VacaValley Hospital, in Vacaville, Calif., are now being monitored.
The CDC developed and sent test kits to state and local labs in early February. Even then, those labs were clamoring for the ability to test and questioning why it was taking so long to develop assays for the new coronavirus.
Because the federal government declared the coronavirus outbreak an emergency, state and local laboratories are prohibited from using tests developed in-house. They could only use tests that had received an emergency use authorization from the Food and Drug Administration. In this context, that means the CDC test.
When laboratories start to use a new CDC-designed test, they have to first assess their own ability to run the tests accurately, and report back to the CDC if they are having problem getting the tests to work in their hands. It quickly became apparent that a lot of the state and local laboratories were having trouble with one part of the test, Health and Human Services Secretary Alex Azar told the House Ways and Means Committee on Thursday, adding that the CDC “probably, in retrospect, maybe over-engineered [the test] a bit.”
The CDC told the few states that weren’t having a problem to continue testing and pulled back the kits from the others, which meant that any time those states had a patient who needed to be tested, they had to send the sample to the CDC.
The organization that represents state and local labs — the Association of Public Health Laboratories — was so concerned that on Monday it asked the FDA in a letter if local labs could begin to use in-house tests, executive director Scott Becker said.
“That’s really what led us to reach out to the FDA in really a very public way saying: ‘What else can we do? Because we’re hamstrung here. We’re between a rock and a hard place,’” he told STAT.
https://www.statnews.com/2020/02/27/a-single-...s-unknown/
As her condition worsened — she is on a ventilator — health officials in California asked the CDC to test her for the virus. Because she had not been to China and had not been a contact of a known case, the agency said no.
Eventually, more than 10 days after she went into hospital, the CDC agreed she could be tested. Dozens of health workers who may have come into contact with her at NorthBay VacaValley Hospital, in Vacaville, Calif., are now being monitored.
The CDC developed and sent test kits to state and local labs in early February. Even then, those labs were clamoring for the ability to test and questioning why it was taking so long to develop assays for the new coronavirus.
Because the federal government declared the coronavirus outbreak an emergency, state and local laboratories are prohibited from using tests developed in-house. They could only use tests that had received an emergency use authorization from the Food and Drug Administration. In this context, that means the CDC test.
When laboratories start to use a new CDC-designed test, they have to first assess their own ability to run the tests accurately, and report back to the CDC if they are having problem getting the tests to work in their hands. It quickly became apparent that a lot of the state and local laboratories were having trouble with one part of the test, Health and Human Services Secretary Alex Azar told the House Ways and Means Committee on Thursday, adding that the CDC “probably, in retrospect, maybe over-engineered [the test] a bit.”
The CDC told the few states that weren’t having a problem to continue testing and pulled back the kits from the others, which meant that any time those states had a patient who needed to be tested, they had to send the sample to the CDC.
The organization that represents state and local labs — the Association of Public Health Laboratories — was so concerned that on Monday it asked the FDA in a letter if local labs could begin to use in-house tests, executive director Scott Becker said.
“That’s really what led us to reach out to the FDA in really a very public way saying: ‘What else can we do? Because we’re hamstrung here. We’re between a rock and a hard place,’” he told STAT.
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