I'm actually a bit puzzled by this. This is RT-PCR based, so why can't off the shelf lab supplies be used? Oligo synthesis commonly has next day turnaround at this point, so primers can't be the issue... Is this purely a regulatory bottleneck?
> The test kit has not been FDA cleared or approved, however distribution and use of the test kits follows the U.S. Food and Drug Administration (FDA) February 4, 2020, issuance of an Emergency Use Authorization (EUA). The tests are being shipped through the International Reagent Resource (IRR), a CDC-established mechanism that distributes laboratory reagents domestically and globally.
> Is this purely a regulatory bottleneck?
That seems likely. It needs to be shipped through a particular resource, under particular constraints that lie outside the norm:
> The CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel was developed for qualified domestic public health laboratories to detect SARS-CoV-2. The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) on February 4, 2020, to enable emergency use of the test kit in the United States. CDC has produced EUA and Research Use Only (RUO) test kits that are now available to order by domestic and international public health partners through IRR.
Interesting read. It doesn't explain though why "the people in charge" haven't issued a blanket authorization by now for basic RT-PCR based diagnostics using a particular primer sequence at facilities meeting some minimum criteria.
Other countries have managed to authorize and implement drive-thru testing stations [1] by now; it really seems like we're demonstrating our ineptitude here.
The FDA is a big slow bureaucracy. Also, all of their incentives are to block new things. If they approve a new medical treatment or diagnostic that ends up harming people, they'll get tons of bad publicity and the individuals who approved it could lose their jobs. If they block things, few seem to notice (see everyone in this thread talking about CDC funding being cut).
For example: The FDA took a decade longer than the rest of the world to approve the first beta-blocker (timolol). That caused around 100,000 deaths. The FDA is also the reason why epipens are so expensive (along with countless other generic drugs).[1]
That said, it looks like they'll approve a standard covid19 test soon.[2]
Unfortunately, a number of these kits have turned out to be faulty, a discovery only widely noticed a few days ago. [1]
It'll take time for them to redistribute the kits.
[0] https://www.cdc.gov/media/releases/2020/p0206-coronavirus-di...
[1] https://www.washingtonpost.com/health/2020/02/25/cdc-coronav...