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flatbutt's Avatar
 
Join Date: Nov 2002
Location: NJ
Posts: 29,928
CoVid 19 testing

OK let's get this started:


On Monday, February 3, 2020, CDC submitted an Emergency Use Authorization (EUA) package to the U.S. Food and Drug Administration (FDA) in order to expedite FDA permitted use of the CDC diagnostic panel in the United States. The EUA process enables FDA to consider and authorize the use of unapproved, but potentially life-saving medical or diagnostic products during a public health emergency. The U.S. Secretary of Health and Human Services declared the SARS-CoV-2 virus a U.S. public health emergency on Friday, January 31, 2020. FDA issued the EUA on February 4, 2020. IRR began distribution of the test kits to states, but shortly thereafter performance issues were identified related to a problem in the manufacturing of one of the reagents which led to laboratories not being able to verify the test performance. CDC is remanufacturing the reagents with more robust quality control measures. New tests will be distributed once this issue has been addressed. CDC continues to perform initial and confirmatory testing.

Serology Test for COVID-19
...
The serology test will look for the presence of antibodies, which are specific proteins made in response to infections. …..
Initial work to develop a serology test for SARS-CoV-2 is underway at CDC. In order to develop the test, CDC needs blood samples from people who had COVID-19 at least 21 days after their symptoms first started. ….

Where are these kits coming from?

https://www.voanews.com/science-health/coronavirus-outbreak/million-covid-19-test-kits-expected-us-labs-soon-hhs-chief-says

Here?

https://www.yahoo.com/entertainment/chinese-billionaire-donate-coronavirus-test-173814987.html

I do wonder how the Chines billionaire got 500.000 kits , how can they be spared and how good are they? I'm still searching.

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Old 03-13-2020, 01:05 PM
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RWebb's Avatar
 
Join Date: Jul 2007
Location: Greater Metropolitan Nimrod, Orygun
Posts: 55,993
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I'll back it up a bit...

There are 3 ways to test for the virus (not counting a CT scan to look for pneumonia... not specific for covid-19 anyway)

1. PCR - this type of test looks for a specific gene sequence found only in certain coronaviruses; the Berlin developed test that was adopted by WHO was of this type, as was the CDC initial no worky test, and several others

2. antibody assays (see OP) - nice b/c they will give a + even if the person has recovered from the virus; there are a few types; S. Korea has one that gives real time results in 10 minutes (in the lb - I don't think it is deployed yet)

3. Sequencers - these resolve the nucleic acid chain (sequence) of the virus - they are now automated and fit on top of a lab bench; I dunno if they are field operable (but a sample could be taken in the field and taken to a building nearby); they are much more rapid than the ones used for the Human Genome Project - my guess is tens of minutes to a couple of hours AFTER they get the sample

You can expect a rush to develop and deploy all types.
Old 03-13-2020, 02:06 PM
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pmax's Avatar
 
Join Date: May 2014
Location: SF Bay Area
Posts: 18,102
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Testing, testing, testing

Everyone in Congress should be tested by now.

Old 03-13-2020, 04:45 PM
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