4 ms·
This seems like a really good idea but I worry about regulatory approval. Tests like these will tend to catch any Covid-19 cases in the window where you have a
by Symmetry 6y ago
This seems like a really good idea but I worry about regulatory approval. Tests like these will tend to catch any Covid-19 cases in the window where you have a real chance of infecting someone from maybe 2 days pre-symptom onset to a few days post onset. And that's really all you need from an epidemiological standpoint. But from a medical standpoint if someone comes into your ER a week post symptom onset you want to know if they've got Covid-19 whether or not they're still infected, from a medical standpoint. And in that use case this is less likely to produce the correct answer than the already existing PCR test and the time lag probably isn't that important. It would be reasonable to allow it anyways but the FDA's rules are set up for the benefit of medical uses rather than epidemiological uses and I wouldn't be optimistic about it getting allowed baring pressure from above.
Also
>One researcher spiked 30 out of 60 saliva samples with inactivated SARS-CoV-2 in the lab. Then they shuffled the samples and gave them to another scientist to test with the RT-LAMP technology.
I wonder if that required a BSL-3 facility or not. Generally you can do medical work on this virus with any sort of facility or laboratory you have on hand but you're only allowed to do science involving the virus if you have a special laboratory with negative pressure and special failsafes and so on.
- averros 6y agoGiven widespread SARS2 infection in the general population, requiring to work on this virus in BSL-certified lab is rather... silly.
- icegreentea2 6y agoSpiking inactivated virus does not require BSL-3. You only need BSL-3 for isolating and growing live virus. So the vendors that create inactivated virus are doing so in BSL-3 facilities, but once it's inactivated you can work with it at much lower stringency. Seems like BSL-2 is standard.