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There are many RT-PCR LDTs. It does not take very much to create a real-time RT-PCR LDT for COVID-19; two weeks ago the CDC posted a comprehensive description o
by ak217 7y ago
There are many RT-PCR LDTs. It does not take very much to create a real-time RT-PCR LDT for COVID-19; two weeks ago the CDC posted a comprehensive description of the process on their website, but it was not a secret before then. All you need is a clinical-grade RT-PCR machine, synthesized primer/probe DNA (which many labs are equipped to do), and quality reagents.
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.
- bewaretheirs 7y agoCDC'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).
- ak217 7y agoTheir 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.)