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The report about the CDC SARS-Cov-2 test is out. Plenty went wrong. But the timeline still seems puzzling. In the course of January @WHO began making protocols for molecular tests available. The US authorities decided to use the CDC protocol. 1/n
For use at CDC the test worked. A scaled up version of the CDC protocol was made, it seems, at the CDC. These were assays for the public health labs. Much of February was lost due to the tests delivering spurious results. 2/n
The Respiratory Virus Diagnostic Lab developed a test in January, asked a CDC core lab to help make it. Not stated, but this likely involved primers and probes as well as negative and positive controls. Made them in Jan. What seems unclear is if validation tests were run. 3/n
Feb 8 CDC realized something was amiss with test, according to HHS report. CDC had new tests made. Using an external company. One company, IDT, told me through a spokesperson that they were asked on Feb 25 about producing the reagents for the kit. 4/n
Kit was produced. On March 5, FDA received request from CDC to authorize use of this kit--primers, probes additional reagents--so they could send to public health labs. The month of February came and went. 5/n
At this time other countries had tests that worked, but it seems, not the US. It seems that the whole system of scale-up didn't work. Although there must be emergency preparedness pans for widespread use of PCR-based tests. hmm there still seem to be some blanks. 6/n
Each country has national approvals for tests. There's a global situation that is solved on a national level. Scale-up means tests are available on a massive scale so every every hospital with patients with COVID-19 symptoms has tests. 7/n
And then, later, every neighborhood can test. Everywhere. Researchers have said to me: most anyone knows how to do RT-PCR, which was possible in January once the virus was sequenced. But one needs to have all reagents be uniform, quality-tested so results can be compared. 8/n
These are the OLD primer sequences and probes in the OLD CDC test that has now been found to have been contaminated. cdc.gov/coronavirus/20… It was previously not labeled this way but now it says on the page: 9/n
"Reagents manufactured from these sequences may not be used for viral testing under FDA’s authorization of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel."..."These sequences are intended to be used for the purposes of respiratory virus surveillance and research. "... 10/n
..."CDC cannot provide any warranty regarding their accuracy."... the protocol dated June 13, 2020 is here tinyurl.com/yb47m3a7 I do not see the primer sequences but might be missing that. To control COVID-19, one needs tests on a massive scale. 11/n
In January, the virus was sequenced. In the US, in February, only the CDC test could be used at the CDC. Then it was appended with "Emergency Us Authorization" (EUA) so all public health labs could use it. But the test didn't work. In late Feb one (1) test received an EUA. 12/n
In March in the US 20 tests were approved with an EUA. It was hard to scale up reagent production. As of today there are over 80 of these tests. I imagine they have all been validated. @Laurie_Garrett will know...one might not be able to stockpile test-kits but ...13/n
...pandemic prep might involve having reagents. The clock ticked from the moment the virus sequence was available in January, which is when you can start with RT-PCR protocols. It seems there is still a lot of info to be gathered on what has gone right and wrong....to now. 14/n
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