SYSTEM AND METHOD FOR DETERMINING CLINICAL EQUIVALENCE OF TESTING METHOD

摘要

PROBLEM TO BE SOLVED: To provide a system, a method, and a computer readable medium of instructions, which are useful for determining whether an evaluating testing method or device is clinically equivalent to a reference testing method or device.SOLUTION: A report can include a modified mean difference plot, a variability chart, confidential intervals for bias, and a plot of the intervals. A graphical user interface is provided so as to allow data associated with a reference method or device and an evaluation method or device to be identified. A variation level in the reference method is determined. A bias observed between the evaluation method or device and the reference method or device is calculated. The confidential intervals for bias are calculated. The bias between the evaluation method or device and the reference method or device is compared with the variation level in the reference method, and a report including the result about whether the evaluation method or device is clinically equivalent to the reference method or device is generated.