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Abstract:
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A common way of validating an assay for precision is through the m:n:b procedure, where m levels of an analyte are measured with n replicates at each level, and if all m estimates of coefficient of variation (CV) are less than b, then the assay is declared validated for precision within the range of the m analyte levels. Two limitations of this procedure are: there is no clear statistical statement of precision upon passing, and it is unclear how to modify the procedure for assays with constant standard deviation. We reframe the procedure as a set of m hypothesis tests, which upon completion delivers a 100q% upper confidence limit on the CV. Additionally, for a post-validation assay output of y, the method gives an ``effective standard deviation interval'' of log(y) +/- r, which is a 68% confidence interval on log(mu), where mu is the expected value of the assay output for that sample. Further, the m:n:q procedure can be straightfowardly applied to constant standard deviation assays. We apply this new precision validating procedure to a growth inhibition assay.
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