Comparative analysis of calculating sigma metrics by a trueness verification proficiency testing-based approach and an internal quality control data inter-laboratory comparison-based approach

Abstract

Introduction: Two methods were compared for evaluating the sigma metrics of clinical biochemistry tests using two different allowable total error (TEa) specifications. Materials and methods: The imprecision (CV%) and bias (bias%) of 19 clinical biochemistry analytes were calculated using a trueness verification proficiency testing (TPT)-based approach and an internal quality control data inter-laboratory comparison (IQC)-based approach, respectively. Two sources of total allowable error (TEa), the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) and the People's Republic of China Health Industry Standard (WS/T 403-2012), were used to calculate the sigma metrics (σCLIA, σWS/T). Sigma metrics were calculated to provide a single value for assessing the quality of each test based on a single concentration level. Results: For both approaches, σCLIA > σWS/T in 18 out of 19 assays. For the TPT-based approach, 16 assays showed σCLIA > 3, and 12 assays showed σWS/T > 3. For the IQC-based approach, 19 and 16 assays showed σCLIA > 3 and σWS/T > 3, respectively. Conclusions: Both methods can be used as references for calculating sigma metrics and designing QC schedules in clinical laboratories. Sigma metrics should be evaluated comprehensively by different approaches.