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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 results of HLA genotyping quality assessment of Chinese bone marrow bank volunteers from 2006 to 2014 so as to provide a reference for improving the quality of HLA genotyping of the Chinese marrow database. Methods A 2% random sample was subjected to HLA genotyping review and compared with the typing data at the time of storage, and the error rates of HLA genotyping in each laboratory were statistically analyzed. Results 1) From January 2006 to November 2014, 32 154 samples (2.0%) from 31 HLA genotyping laboratories were actually sampled; 2) Medium and high resolution genes from 2009 to 2014 The proportion of typing data increased year by year, from 2012 onwards, high-resolution genotyping data accounted for more than 90% of the total number of samples tested each year; 3) The proportion of HLA genotyping data from 5 sites in 2010-2014 samples increased year by year , 2014 genotypes of HLA 5 loci accounted for more than 50% of the total number of sampling samples in the year; 4) The total error rate of genotyping of all samples from 2006 to 2014 showed that in 2006 and 2010, The error rate dropped from 1.14% to 0.19% in 2006-2009; the error rate of high-resolution genotyping data in 2010-2014 dropped from 0.51% to 0.17%; 5) 2006 - In 2014, the average error rate of genotyping of samples from all HLA genotyping laboratories showed that two laboratories exceeded the continuous error rate (> 2%). Conclusion The HLA genotyping data quality evaluation project played an active role in reducing the error rate of HLA genotyping data in Chinese bone marrow pool volunteers.