ABSTRACT
Objective To explore the application conditions of 22 S rule (one of the Westgard rules) in single concentration quali‐ty control .Methods The application scope of 22 S rule was used into the same batch detection of single‐concentration quality control materials .Results The 22 S rule improved the detection rate of system errors .Conclusion 22S rule should be applied to two detec‐tions within a batch when using one quality control material ,as to improve the detection of system error more efficiency .
ABSTRACT
Objective Developing an internal quality control substance of Ureaplasma urealyticum(UU)‐DNA for real‐time PCR to establish an internal quality control system and preliminary evaluation its clinical value .Methods Internal quality control sub‐stance was prepared by mixing samples which Ct value were 24-25(positive sample) and 32 -33(weak positive sample) ,respec‐tively .At the same time ,selecting samples that test results were negative as negative control .The target value ,standard deviation (s) and coefficient of variation(CV) of internal quality control substance were defined by“instant method”for the first 20 runs and Levey‐Jennings quality control(QC) chart after the first 20 runs .Using the“Westdard” multi‐rule quality control methods to ana‐lyze the detection results .Exporting OPSPecs chart by quality control rules in Unity Real Time (URT ) system and setting up new quality control rules according with OPSPecs chart .Results 131 times of the detection of quality control substance were performed totally .The first 20 runs were defined by“instant method”and later 111 runs were defined by Levey‐Jennings QC chart ,the results were stable of quality control substance and reasonable quality control rules .Conclusion Preparing of internal quality control sub‐stance of UU‐DNA used in real‐time PCR might be easy and stable .So ,the internal quality control substance of UU‐DNA could be worthy for practical application in this PCR laboratory .Design internal quality control rules based OPSPecs chart in molecular de‐tection is very simple and practical .
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.