CAJ | 학술논문

目的总结并分析2005年至2008年全国医院I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HLA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2 844份,总体错误率为1.05%(30/2 844);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HLA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.
목적 총결병분석2005년지2008년전국의원I림상실험실HLA저분변기인분형검측실간질량평개(EQA)결과,위진일보제고림상실험실HLA기인분형검측수평제공유개치적삼고.방법 근거HLA저분변기인분형검측적특점,용상규통계방법귀납료련속4년EQA활동적결과,분석료근4년EQA활동중회보결과적착오솔이급도치착오결과적가능원인.결과 2005년지2008년,삼여HLA저분변기인분형검측EQA항목적 림상실험실종22가증가도61가;련속4년EQA활동중회보수거공계2 844빈,총체착오솔위1.05%(30/2 844);매년출현착오적실험실비솔분별위13.6%(3/22)、10.7%(3/28)、10.6%(5/47)、16.4%(10/61);련속4년EQA활동중착오수거공계30빈,착오류형주요포괄HLA기인분형착오25빈、인위착오5빈.결론 목전아국림상실험실HLA저분변기인분형검측착오적비례과고;유우착오류형이기인분형착오화인위착오위주,반영료종업인원재HLA기인분형기술상존재불용홀시적문제.
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.