SYSTEM AND METHOD FOR DETERMINING CLINICAL EQUIVALENCE OF TEST METHOD

摘要

PPROBLEM TO BE SOLVED: To provide a system, method and computer readable medium of instructions, which are useful for determining whether an evaluation testing method or device is clinically equivalent to a reference test method or device. PSOLUTION: A report can include a modified mean difference plot, a variability chart, confidence intervals for bias and a plot of the intervals. A graphical user interface is provided to allow data associated with a reference method or device, and an evaluation method or device to be identified. A level of variance in the reference method is determined. An observed bias between the evaluation method or device and the reference method or device is calculated. A confidence interval for the bias is calculated. The biases between the evaluation method or device and the reference method or device is compared relative to the level of variance in the reference method, and a report is generated including a conclusion about whether the evaluation method or device is clinically equivalent to the reference method or device. PCOPYRIGHT: (C)2011,JPO&INPIT