CLSI C51-A-2012 PDF

Scope: This guideline explains the concept, estimation, and application of measurement uncertainty in the field of clinical laboratory medicine. The recommendations provided are consistent with the Guide to the expression of uncertainty in measurement (GUM) and with the International Organization for Standardization (ISO) standards concerned with laboratory accreditation. This guideline briefly discusses, but does not fully address, the following nonmeasurement sources of uncertainty of a measurement result: ? Biological variation of the measurand ? Pre- and postmeasurement processes The guideline discusses the definition of what is intended to be measured, lists sources of measurement uncertainty, describes the generation of statistical estimates of uncertainties and their combination, and discusses the use of uncertainty estimates. The guideline applies only to quantitative measurements. In measurement procedures that are reported in qualitative terms based on a quantitative measurement, the uncertainty at the threshold(s) for a qualitative interpretation should be considered when making the qualitative assessment. This guideline is intended for clinical laboratories and in vitro diagnostic (IVD) device manufacturers.

CLSI C51-A-2012 history

2012 CLSI C51-A-2012 Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline