2005年至2008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： 2005 -2008 activities

目的 总结并分析2005年至2008年全国医院临床实验室HLA低分辨基因分型检测室间质量评价（EQA）结果，为进一步提高临床实验室HLA基因分型检测水平提供有价值的参考。方法根据HLA低分辨基因分型检测的特点，用常规统计方法归纳了连续4年EQA活动的结果，分析了近4年EQA活动中回报结果的错误率以及导致错误结果的可能原因。结果2005年至2008年，参与HTJA低分辨基因分型检测EQA项目的临床实验室从22家增加到61家；连续4年EQA活动中回报数据共计2844份，总体错误率为1．05％（30／2844）；每年出现错误的实验室比率分别为13．6％（3／22）、10．7％（3／28）、10．6％（5／47）、16．4％（10／61）；连续4年EQA活动中错误数据共计30份，错误类型主要包括HIA基因分型错误25份、人为错误5份。结论目前我国临床实验室HLA低分辨基因分型检测错误的比例过高；由于错误类型以基因分型错误和人为错误为主，反映了从业人员在HLA基因分型技术上存在不容忽视的问题。

Objective National external quality assessment （EQA） results from 2005 to 2008 for HLA class Ⅰ （A, B） and class Ⅱ（DRB1） low-resolution DNA typing were summarized with the goal of exploring strategies to assure and improve HLA DNA typing performance in clinical testing. Methods HLA allele results from the four 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 four consecutive years with the number of 22, 28, 47 and 61 in 2005, 2006, 2007 and 2008 ,respectively. 2 844 HLA DNA typings were returned from the participants during the 4 years EQA surveys, and overall 30 errors （1.05%） were identified. These 30 errors were classified into two major types of errors including 25 technical genotyping errors and 5 human errors. The proportion of laboratory participants which made mistakes was 13.6% , 10. 7% , 10. 6% and 16.4% in 2005, 2006, 2007 and 2008, respectively. Conclusions Above 10% of participant laboratories exhibited errors in the four consecutive years HLA molecular typing EQA surveys. Relevant important attentions should be greatly paid to clinical HLA molecular typing test.