Application of proficiency testing/external quality assessment samples in trueness verification of electrochemiluminescence procedure

doi:10.3969/j.issn.1673-8640.2019.09.019

Abstract

Abstract:

Objective To investigate the role of proficiency testing（PT）/external quality assessment（EQA） samples in trueness verification of electrochemiluminescence procedure. Methods The trueness of electrochemiluminescence procedure,such as free triiodothyronine（FT₃）and estradiol（E₂）,was verified according to the Clinical and Laboratory Standards Institute（CLIS） EP15-A3 document 5×5 experimental design,using the samples of PT/EQA of the National Center for Clinical Laboratories. The experimental procedure,1 run per day for 5 d and 5 replicates per run,was performed. The outliers were calculated by Grubbs' test,and one way ANOVA test was used to calculate the repeatability variance（S_R）of users,the within-laboratory variance （S_WL）,the overall standard error（SE_x ）,the standard error of target value（SE_RM）and the combined standard error（SE_C）. The m value was obtained from the T distribution table according to the degree of freedom（df_C）. Finally,the verification interval was calculated. If the overall mean was within the verification interval,the trueness verification passed,and if out,the bias was calculated and compared with the laboratory-specified target bias. Results The overall mean values of FT₃ and E₂were within the correctness verification interval,and the trueness was verified. Conclusions The samples from PT/EQA can be used as a reference material for trueness verification of laboratory determination procedure.

Key words: Proficiency testing, External quality assessment, Trueness verification, Electrochemiluminescence procedure

CLC Number:

R446.1

GUO Xuxiao, BAI Shumei, LING Xin, GAO Jie, LI Jinxing. Application of proficiency testing/external quality assessment samples in trueness verification of electrochemiluminescence procedure[J]. Laboratory Medicine, 2019, 34(9): 851-854.

项目	总体均值	最小值	最大值	Grubbs'下限	Grubbs'上限	是否有离群点
FT₃（uIU/mL）
低浓度	3.94	3.86	4.02	3.79	4.09	否
高浓度	22.33	20.20	23.70	19.76	24.90	否
E₂（pmol/mL）
低浓度	293.67	269.80	312.40	251.96	335.37	否
高浓度	2 138.32	1 896.70	2 396.70	1 732.28	2 544.36	否

项目	总体均值	最小值	最大值	Grubbs'下限	Grubbs'上限	是否有离群点
FT₃（uIU/mL）
低浓度	3.94	3.86	4.02	3.79	4.09	否
高浓度	22.33	20.20	23.70	19.76	24.90	否
E₂（pmol/mL）
低浓度	293.67	269.80	312.40	251.96	335.37	否
高浓度	2 138.32	1 896.70	2 396.70	1 732.28	2 544.36	否

项目	总体均值（x）	批内标准差（S_R）	室内标准差（S_WL）	总体合成标准误（SE_x）	定值标本标准误（SE_RM）	合成标准误（SE_C）
FT₃（uIU/mL）
低浓度	3.94	0.038	0.051	0.016 7	0.009 5	0.019 2
高浓度	22.33	0.800	0.843	0.199 0	0.027 4	0.200 8
E₂（pmol/mL）
低浓度	293.67	12.863	13.716	3.339 4	0.817 6	3.438 0
高浓度	2138.32	213.396	133.877	33.873	3.135 6	34.032

项目	总体均值（x）	批内标准差（S_R）	室内标准差（S_WL）	总体合成标准误（SE_x）	定值标本标准误（SE_RM）	合成标准误（SE_C）
FT₃（uIU/mL）
低浓度	3.94	0.038	0.051	0.016 7	0.009 5	0.019 2
高浓度	22.33	0.800	0.843	0.199 0	0.027 4	0.200 8
E₂（pmol/mL）
低浓度	293.67	12.863	13.716	3.339 4	0.817 6	3.438 0
高浓度	2138.32	213.396	133.877	33.873	3.135 6	34.032

项目	总体均值（x）	tau值	自由度（dfc）	m值	验证值区间（VI）	验证结果
FT₃（uIU/mL）
低浓度	3.94	0.567 9	7	3.499	3.833~3.967	通过
高浓度	22.33	0.137 6	4	4.604	20.975~22.825	通过
E₂
低浓度	293.67	0.244 8	5	4.032	270.14~297.86	通过
高浓度	2 138.32	0.092 5	4	4.604	1 901.3~2 214.7	通过

Application of proficiency testing/external quality assessment samples in trueness verification of electrochemiluminescence procedure

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