Application Comparison of Two Source of Allowable Total Errors inσMetrics Assessing the Analytical Quality and Selecting Quality Control Procedures for Automated Clinical Chemistry / 现代检验医学杂志

ABSTRACT

Objective To evaluate the difference of two sources of allowable total errors provided by National Health Industry Standard (WS/T 403-2012,analytical quality specification for routine analytes in clinical biochemistry)and National Stand-ard (GB/T 20470-2006,requirements of external quality assessment for clinical laboratories)in assessing the analytical qual-ity byσmetrics,and selecting quality control procedures using operational process specifications graphs.Methods Selected one of the laboratories participating in the internal quality control activity of routine chemistry of February,2014 and the first time external quality assessment activity of routine chemistry in 2014 organized by National Center for Clinical Labora-tories for its coefficient of variation and the bias of nineteen clinical chemistry tests.With the CV% and Bia%,σmetrics of controls at two analyte concentrations were calculated using two different allowable total errors targets (National Health In-dustry Standard (WS/T 403-2012)and National Standard (GB/T 20470-2006).Could obtain a operational process specifica-tions graph by which Could select quality control procedures using the Quality control computer simulat software developed by National Center for Clinical Laboratories and the company zhongchuangyida.Results The σ metrics under National Health Industry Standard (WS/T 403-2012)were from 0 to 7.Most of the values (86% and 76.2%)under National Stand-ard (GB/T 20470-2006)were from 3 to 15.On the normalized method decision chart,the assay quality using the allowable total errors targets of National Standard (GB/T 20470-2006)was at least one hierarchy more than one using National Health Industry Standard (WS/T 403-2012).The quality control rules under National Health Industry Standard (WS/T 403-2012)were obviously more strict than that under National Standard (GB/T 20470-2006).Among the control procedures using National Health Industry Standard (WS/T 403-2012),multirule (n=4):ALB,ALP,Ca,Cl,TC,Crea,Glu,LDH,K, Na,TP,TG and Urea;13s (n=4):Mg;12.5s (n=2):CK,AMY ang Fe;13s (n=2):TBIL;13.5s (n=2):ALT,AST and UA.Conclusion The allowable total errors provided by National Health Industry Standard (WS/T 403-2012)are more stringent than that from National Standard (GB/T 20470-2006).So Laboratories need to improve the analytical quality of their tests furthermore.