Patent ID: 7440856

Claim:
A method of determining whether an evaluation testing method is clinically equivalent to a reference testing method, comprising the steps of: determining a level of variance in results obtained using samples from each of a plurality of sources using a reference method, determining a standardized bias for the samples from each of the plurality of sources relative to the results from the reference method and the level of variance of the results from the reference method, obtaining an average bias from the standardized bias, determining a variability of the average bias from the standardized bias, iteratively computing a percentage of results from the evaluation testing method that occur within the variability of the reference method, concluding that the evaluation testing method is equivalent to the reference method if the computed percentage is 95% or greater, and generating a report including, in part, results of the reference method, results of the evaluation testing method, the average bias, the variability, and a conclusion of equivalence, wherein samples used in the reference method and samples used in the evaluation testing methods are from the same sources.