2009-2014年全国HLA低分辨基因分型检测室间质量评价结果分析

National External Quality Assessment for HLA low-resolution molecular typing: 2009-2014 activities

目的为进一步提高全国临床实验室人类白细胞抗原(HLA)基因分型检测水平提供有价值的参考。方法利用常规统计方法归纳总结2009-2014年全国医疗机构和商业临床实验室HLA低分辨基因分型检测室间质量评价(EQA)结果,分析在连续6年的EQA活动中,回报结果的错误率、错误类型以及导致错误结果的原因。结果2009-2014年全国参加HLA低分辨基因分型检测EQA项目的临床实验室数目从63家增至83家;在连续6年EQA活动中,回报HLA分型数据共计7 836份,总体错误率为2.12%(166/7836);2009-2014年每年出现错误的实验室比例分别为1.59%(1/63)、11.48%(7/61)、0.00%(0/69)、2.74%(2/73)、2.82%(2/71)、10.84%(9/83);连续6年EQA活动中错误数据共计166份,主要包括HLA基因分型错误23份、血清型和基因型混淆错误14份、录入错误108份,漏报错误21份。结论目前我国临床实验室HLA低分辨基因分型整体检测水平仍不容乐观,错误比例过高;反映了从业人员在HLA基因分型技术上和规范化管理上存在不容忽视的问题。

Objective Aiming at exploring strategies to assure and improve HLA genotyping performance in clinical tes- ting, national external quality assessment （EQA） results from 2009 to 2014 for HLA low-resolution genotyping were summa- rized. Methods HLA allele results from the six consecutive years EQA events were analysed. Different kinds of errors were described and classified, and the possible causes were discussed. Results Participant laboratories were increasing in the six consecutive years with the number of 63, 61,69, 73, 71 and 83 in 2009, 2010, 2011,2012, 2013 and 2014 respectively. 7386 HLA genotyping results were returned from the participants during the 6 years EQA surveys, and overall 166 errors （2. 12% ） were identified. These 166 errors were classified into four major types of errors including 23 technical genotyping errors, 14 Serotype and genotype confusion errors, 108 typing input mistakes and 21 missing errors. The proportion of laboratory participants which made mistakes was 1.59%, 11.48% ,0. 00% ,2. 74% ,2. 82%, 10. 84% in 2009, 2010, 2011, 2012, 2013 and 2014, respectively. Conclusion The overall performance of HLA low-resolution genotyping test in the participant laboratories is still not optimistic in the six consecutive years EQA surveys. Relevant important attentions should be greatly paid to clinical HLA molecular typing test.