Minimum samples for q6 month correlations
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How many samples do you use for q6 month correlation studies? I was recently informed by an application specialist that it is not necessary to use 20 samples as our lab traditionally has done. I cannot find specific guidelines from regulatory agencies on this topic. Westgaard's New Poor Lab's Guide to the Regulations doesn't even address this topic; which is shocking to me.
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Most tests correlations we do 10 samples, one test that we've been using for over 15 years and is very stable we only do 5.
Initial validations we do anywhere from 20 to 100, again depending on the test and results obtained.
Our medical director approved using 3 samples twice per year. I wouldn't feel comfortable doing less than what CAP expects but one could always do more.
Hope this helps!
Erika