CLSI EP05-A2

Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition

NCCLS document EP5-A2, Evaluation of Precision Performance of Quantitative Measurement Methods; Approved Guideline - Second Edition provides guidance and procedures for evaluating the precision of in vitro diagnostic devices and includes recommendations for manufacturers in evaluating their devices and methods when establishing performance claims. Included are guidelines for the duration, procedures, materials, data summaries, and interpretation techniques that are adaptable for the widest possible range of analytes and device complexity. The procedures are designed for manufacturers or developers of clinical laboratory measurement methods, and for users of those methods who wish to determine their own performance capabilities or to verify claims from a manufacturer. A balance is created in the document between complexity of design and formulae, and simplicity of operation.