RE: Tired of delays, U.S. labs ask FDA to develop their own coronavirus tests25 Feb 2020 13:30
posted last night but relevant here:
https://www.rapidmicrobiology.com/news/primerdesign-the-first-european-team-to-deliver-to-the-world-a-2019-ncov-diagnostic-kit
See the last question:
Q: What will happen should the virus continue to mutate?
A: Viruses inherently have a high mutation rate. Should the targeted region of the virus mutate, the specificity of the assay may be reduced, which would be the same for any competitor kit or PCR assay. To combat this, as the sequence data is collected from newly 2019-nCoV infected patients from around the world and then published, our in-house bioinformatics team reviews this daily to check our detection assay has homology with all of these published sequences, and can still detect all positive 2019-nCoV samples.
Thus, the in-house bioinformatics team reviews newly published swab data, to ensure the detection assay can still detect all positive 2019-nCoV samples.
So as long as the bioinformatics team are kept busy with fresh data, medical authorities can be assured that Primerdesign knows how the virus is mutating (or not), and will instigate any measures required that assure the detection assay is still fit for purpose.
How many competitors can make this claim?
This might be the reason why the CE mark has been awarded.