Journal of Modern Laboratory Medicine 2016;31(5):147-149

doi:10.3969/j.issn.1671-7414.2016.05.044

Trueness Controls of Clinical Laboratory to Assess Bias

Xiaoyan ZHANG ; Wei WANG ; Zhiguo WANG

Keywords

trueness controls; bias; statistical quality control; systematic error

Country

China

Language

Chinese

Abstract

Precision controls monitor assay random error (reproducibility),accuracy controls assess total error,both random error and systematic error,and trueness (bias)of an assay represents systematic error.A trueness control should be metro-logical traceable,ideally with a target value determined by use of a reference material or a reference method,without metro-logical traceable to a reference measurement system,patient test results for the same patient from different laboratories may not be comparable.A trueness control should be commutable and its analytical response to a reference method and a routine field method should be equivalent to that of a patient sample.And trueness control values should generally be set at medical decision levels and be prepared by the providers of reference materials and manufactured in the same fashion as a calibrator.