[printfriendly]
December 2013—The Clinical and Laboratory Standards Institute has released the latest version of a document addressing the design of measurement procedure comparisons using patient samples and subsequent data-analysis techniques for determining the bias between two in vitro diagnostic measurement procedures.
The document, titled “EP09-A3-Measurement Procedure Comparison and Bias Estimation Using Patient Samples; Approved Guideline-Third Edition,” provides additional reasons for comparisons based on patient samples; regression descriptions, including weighted options, Deming, and Passing-Bablok techniques; measurement of bias at clinical decision points; and outlier detection using extreme studentized deviate.
Jeffrey R. Budd, PhD, EP09-A3 document chairholder of Beckman Coulter, emphasized the practical nature of this guideline. “There are almost no equations outside of the appendices, and the concepts are almost always portrayed visually, as well as in written text,” he said.
EP09-A3 can be used by clinical laboratory personnel; manufacturers of in vitro diagnostic reagents, including those who create laboratory-developed tests; and regulatory bodies.
CLSI, 610-688-0100