External quality assessment for epidermal growth factor receptor gene mutation determination in Shanghai

doi:10.3969/j.issn.1673-8640.2017.011.026

Abstract

Abstract:

Objective To evaluate the external quality assessment（EQA） performance for epidermal growth factor receptor（EGFR） gene mutation determination in Shanghai,and to discuss and solve the problems in clinical laboratories in order to improve determination quality. Methods EQA program for EGFR determination was set twice a year. Each sample panel of 2016 EQA program contained 5 samples. The participating laboratories were asked to report their results before deadline. The scores of EQA and the overall coincidence rate of each sample were calculated. The overall coincidence rate of positive samples and negative ones were also calculated. Results In 2016,25 and 30 valid laboratory results were received. Totally,20（80%）and 26（87%）laboratories submitted correct results for all samples,and the EQA score of 0（0%） and 1（3%） laboratory was <80. The highest coincidence rate of the samples was 100%,and the lowest rate was 88%. The overall coincidence rates of positive samples and negative ones were 95.76% and 97.27%,respectively. Missed determination in composite mutation samples was a major cause for inconsistency,which was up to 50%（5/10）. Conclusions The results of 2016 EQA program suggest that the overall coincidence rate of laboratories enrolled is high,while there exists problems in some laboratories. Missed determination in composite mutation samples is a major cause for inconsistency. Quality control in clinical laboratories is essential to assure accuracy of results.

Key words: Epidermal growth factor receptor, Gene mutation, External quality assessment

CLC Number:

R446.1

JIANG Lingli, XIAO Yanqun, WANG Xueliang, BAO Yun, YANG Yixiao, WANG Hualiang. External quality assessment for epidermal growth factor receptor gene mutation determination in Shanghai[J]. Laboratory Medicine, 2017, 32(11): 1055-1058.

Figures/Tables 2

References 7

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方法	100分		80分		<80分
方法	第1次（25家）	第2次（30家）	第1次（25家）	第2次（30家）	第1次（25家）	第2次（30家）
ARMS	17	22	4	2	0	1
实时荧光PCR	3	3	1	0	0	0
Sanger测序	0	0	0	1	0	0
其他	0	1	0	0	0	0
合计（%）	20（80.00）	26（86.67）	5（20.00）	3（10.00）	0（0.00）	1（3.33）

方法	100分		80分		<80分
方法	第1次（25家）	第2次（30家）	第1次（25家）	第2次（30家）	第1次（25家）	第2次（30家）
ARMS	17	22	4	2	0	1
实时荧光PCR	3	3	1	0	0	0
Sanger测序	0	0	0	1	0	0
其他	0	1	0	0	0	0
合计（%）	20（80.00）	26（86.67）	5（20.00）	3（10.00）	0（0.00）	1（3.33）

样本号	预期基因型	结果符合实验室数	符合率（%）
第1次EQA
1621	L858R+T790M	22	88
1622	野生型	24	96
1623	19del	25	100
1624	L858R	24	96
1625	野生型	25	100
第2次EQA
1631	L858R	29	97
1632	19del	30	100
1633	L858R+T790M	28	93
1634	野生型	30	100
1635	野生型	28	93

样本号	预期基因型	结果符合实验室数	符合率（%）
第1次EQA
1621	L858R+T790M	22	88
1622	野生型	24	96
1623	19del	25	100
1624	L858R	24	96
1625	野生型	25	100
第2次EQA
1631	L858R	29	97
1632	19del	30	100
1633	L858R+T790M	28	93
1634	野生型	30	100
1635	野生型	28	93

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