Another rant about why it’s dangerous to trust #nCoV2019 “experts” with no credibility in epi or virology, and obviously a minimal understanding of fundamental molecular biology or ID diagnosticspic.twitter.com/drRn9GOqHJ
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The second test had “perfect” sensitivity. Perfect is not a quantifiable metric. What does that even mean? That it’s very sensitive? Because the paper measures that by diluting the template, and it’s consistent with what you’d expect for RT-PCR. It’s fine, not “perfect”
And 100% specificity? The second test was only validated in a tiny cohort (pos n=2, neg n=31), no wonder there weren’t false positives. That’s not even remotely in the realm of statistical power you’d need to validate something for clinical use.
The problem with getting information from an “expert” who evidently knows approximately zero about molecular assays is that these both are presented like #nCoV2019 tests coming soon to a clinic near you! Nope. Neither test is ready for use as the diagnostic.
And the last thing anyone anywhere needs is a bunch of people overwhelming providers with demands for tests that are either unproven technology not yet evaluated in patients or some primers that haven’t been adequately validated for clinical use
For FDA EUA status, there is validation but no clinical trial (because that would take months). LoD studies, inclusivity, exclusivity and limited testing on banked or contrived clinical samples. These tests are by no means untested.
I’ve always thought the EUA was basically a clinical trial waiver for diagnostics. I’d imagine though there’s probably a lag to get samples for validation here since there are so few cases. That seems to be changing though...
You’re right- RT-PCR is not a new thing. Taking existing CDC primers and making sure they work on fast TAT S2A platforms that are already in diagnostic labs is a helpful step for public health efforts- faster than shipping out. FDA is giving EUA status for these assays.
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