Re:FDA grants Roche coronavirus test emergency green light w...
by bewaretheirs on Saturday March 14, 2020 @01:01PM
(#22576746)
CDC's test instructions and (more importantly) the target RNA/DNA sequences were posted more like 6 weeks ago -- I think I first noticed them in early February, around the time CDC announced that they had applied for an emergency use waiver from the FDA.
They've been revised considerably since then (with a big "research use only" warning on them added).
Re:FDA grants Roche coronavirus test emergency green light w...
by ak217 on Saturday March 14, 2020 @01:03PM
(#22576757)
Their protocol for clinical labs is a superset of the research protocol. (Clinical labs also have extensive prior experience in this kind of protocol, and many state DPH and other labs are in continuous touch with the CDC through CDC's lab network.)
The difference here is that the Roche instrument is pre-approved for clinical use both (1) in the US and (2) outside "high complexity" CLIA labs; the instrument is already widely deployed to hospital labs; and the instrument is highly automated compared to the basic 96-well RT-PCR machine, with a robotic stage that allows it to run thousands of samples per day with less manual work.
The WHO does not have a massive stockpile of complete test kits, and to my knowledge the countries that have scaled up testing are not relying on the WHO for anything but information. Any kits the WHO provides would need to run on an existing RT-PCR machine anyway.