RE: FDA30 Mar 2020 21:22
Wolfiebill,
The point I was making was that these tests have been expedited by the FDA in a very short timescale. I was merely asking what the
conformance with positive test cases were.
They should have the data immediately for release. If they do not then before countries spend vast quantities of money on tests which may not have the desired 100% result, then they need to provide the info ASAP.
Otherwise, the cornerstone of test, test, test breaks apart and chaos ensues.
CDC initially released their own in house test that was not 100% conformance with positive test cases. This put the US on the back foot and probably led to the need for FDA EUA.
Tests should have been independently tested/peer reviewed.
The fact that NCYT makes the bold claim of 100% conformance is irrelevant to the point I was making. The bigger picture is that all FDA EUA tests should show 100% conformance with positive test cases.
The fact that the Roche test has been shown to gave 91% conformance with positive test cases proves my point. This result is surely unacceptable. The FDA now have to confirm this for thenselves in the case of Roche and others.
I was particularly interested in Thermo Fisher as I found no data on conformance towith positive test cases. This is the Company that the UK is going to fund to provide tests for nhs. Its important that these tests are 100%. Hence, someone of authority need to provide the evidence. FDA is best placed to do this. They know what limitations may have been applied in the process of granting FDA EUAs.
I note that NCYT make the bold claim:
The Company continues its extensive surveillance program to monitor strain evolution of the SARS-CoV-2 virus and the latest update continues to demonstrate a 100% homology of its COVID-19 test. To date, this means comparing the Company’s COVID-19 test to genome sequences from 1,700 known variations of COVID-19. The Directors believe this extensive surveillance and performance homology will continue to allow clinicians to use the test with confidence.
Hopefully all the other Companies granted FDA EUAs can make a similar claim to 100% conformance with positive test cases when their test comes under scrutiny. If not, their FDA EUA needs to be withdrawn.
It has been shown that the PrimerDesign does indeed provide 100% conformance to positive test cases in the same measurement study report that identified the Roche test had 91% conformance to positive test cases.
Whitty was indeed correct the 'one thing worse than no test is a bad test". No one can disagree with this.
Hope this clsrifies the point I was making.