2006-2014年中华骨髓库HLA基因分型抽检质量评价结果分析

Evaluation of the quality of HLA typing based on random sampling of CMDP volunteers recruited from 2006 to 2014

目的总结分析2006-2014年中华骨髓库志愿者HLA基因分型抽检质量评价结果,为提高中华骨髓库入库数据的HLA基因分型质量提供参考依据。方法针对2%的随机抽检标本进行HLA基因分型复核,与入库时分型数据进行比对,统计分析各实验室HLA基因分型的错误率。结果 1)2006年1月-2014年11月,实际抽检来自全国31家HLA基因分型实验室的32 154份检测标本(2.0%);2)2009-2014年抽检标本的中、高分辨基因分型数据比例逐年增加,从2012年,起高分辨基因分型数据占每年抽检标本总数的90%以上;3)2010-2014年抽检标本中5位点HLA基因分型数据入库比例逐年增加,2014年度HLA 5位点基因分型数据占全年抽检标本总数的50%以上;4)2006-2014年全部抽检标本基因分型总错误率评价结果显示,在2006年和2010年出现2次错误率高峰,2006-2009年低分辨分型数据的错误率由1.14%降至0.19%;2010-2014年中、高分辨基因分型数据的错误率由0.51%降至0.17%;5)2006-2014年,各HLA基因分型实验室的抽检标本基因分型平均错误率评价结果显示,有2家实验室连续错误率超标(>2%)。结论 HLA基因分型抽检数据质量评价项目对中华骨髓库志愿者HLA基因分型数据错误率的降低发挥了积极作用。

Objective To summarize and analyze the evaluation of the quality of human leukocyte antigen （HLA） as- signments from volunteer donors of China Marrow Donor Program recruited from 2006 to 2014, in order to provide guidance for China Marrow Donor Program and improve the quality of HLA typing. Methods HLA genotyping was performed on 2% of the random samples and comparisons were made between the typing results and previous results. Different types of error rates were calculated and discussed. Results 1 ） Our analysis consisted of 32 154 samples, who were recruited from January 2006 to November 2014. All samples were recruited from 31 laboratories throughout the country. 2） The proportions of inter- mediate, high-resolution typing data increased in CMDP from 2009 to 2014. By the end of 2012, the high-resolution typing data accounted for more than 90 percent of the total sampling data. 3） The proportion of five-locus HLA typing data increased gradually since 2012, By the end of 2014, the five-locus HLA typing data accounted for more than 50 percent of the total sampling data. 4） According to the evaluation results, the higher error rates were found in 2006 and 2010. The errors of low- resolution typing data were mainly observed from 2006 to 2009. However, the errors of high-resolution HLA genotyping were found mainly since 2012. In addition, the error rate of low-resolution data decreased from 1.14% to 0. 19%, and the error rate of high-resolution data also decreased from 0. 51% to 0. 17. 5） The analysis of average error rates of HLA laboratories showed that there were two laboratories which made mistakes by more than 2 percent for two consecutive years from 2006 to 2014. The errors should be rectified in time and the laboratories should be accredited by experts.Conclusion The quality as- sessment of random sampling for HLA typing is effective, and contributes to improvement in the quality of data in CMDP.