Correlation Study

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Correlation Study Posted: Tue Nov 11, 2014 8:27 pm
Are there any regulations that would cause a problem if we had the instrument manufacturer run a correlation study for us?
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Re: Correlation Study Posted: Tue Nov 11, 2014 8:30 pm
CLIA as well as any inspecting agency require that customers participate in the validation of any analyzer.  Validation is precision, accuracy, reportable range and reference range verification.  I am not sure what the purpose of the correlation is.  If it is for validation of a new analyzer then the account technically is supposed to perform the studies. At a minimum you will need to participate in some way and sign off that you did so. If an inspector asks who did the studies and the manufacturer did all the testing then you will be required to do them all over again.  If your answer is, we did them with some assistance from the manufacturer then you will likely be OK.  If the correlations are done for another purpose I don’t see why the manufacturer doing them would be an issue.
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