With the development of a new PCR test, we want to validate this assay to a certain standard. Someone mentioned that a PCR 10 certification would fit perfectly. But we can't find this type of certification for this. Does anybody know what is meant with this?
Stan Aanhane
Hello Dirk Schmidt
,Thank you for your reply. It will be for diagnostics indeed. We have seen papers on where they recall ISO standards, but that is more the process of validation than the required amount of samples. Would you have any advice on the number of samples we would need to run?
With kind regards,
Stan
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