2014～2017年我国临床实验室HbA2和HbF检测室内质控变异系数分析

目的 了解2014～2017年我国临床实验室血红蛋白A₂(HbA₂)和血红蛋白F(HbF)检测室内质控情况。方法 收集2014～2017年参加卫生部临床检验中心室间质评参评单位回报的室内质控信息,将变异系数与1/3TEa(6.67%)和1/4TEa(5%)标准进行比较,得到满足各标准实验室的比例,进而分析我国HbA₂和HbF检测的室内质控情况。按照实验室使用的仪器不同进行分组,分别计算2017年HbA₂和HbF不同仪器组在两种标准下的变异系数通过率。结果 HbA₂项目84%以上的实验室精密度都能达到1/3TEa的标准,达到1/4TEa标准的实验室比例略有降低(70.83%～84.47%)。HbF项目的结果除2015年外,当月和累积在控变异系数80%以上的实验室能达到1/3TEa标准,达到1/4TEa标准的实验室比例分布在68.42%～85.07%。2017年数据按仪器分组统计中,两个项目sebia capillarys 2仪器组和全自动血红蛋白分析仪伯乐VariantⅡ仪器组在两种标准下的变异系数通过率均达85%以上,精密度较好。结论 目前我国实验室HbA₂和HbF检测的不精密度水平需进一步提高,尤其是HbF,实验室应继续加强室内质量控制,建立严格的室内质控制度,提高检测水平。

Analysis of the Coefficient of Variation for the Internal Quality Control of Hemoglobin A2 and Hemoglobin F from 2014 to 2017

Abstract:Objective To investigate the internal quality control(IQC)of hemoglobin A₂(HbA₂)and hemoglobin F(HbF)from 2014 to 2017in China.Methods The results of IQC were collected fromthe laboratories which participated in external quality assessment(EQA)of National Center for Clinical Laboratories(NCCL)from 2014 to 2017,then the coefficient of variation(CV)was compared with 1/3TEa(6.67%),1/4TEa(5%).The proportion of laboratories meeting criteria were calculated to analyze IQC ofHbA₂ and HbF in China.The data were grouped based on the instruments used inlaboratories,the acceptable rates of CVs of HbA₂ and HbF in each group under two criteria in 2017 were calculated,respectively.Results In HbA₂,more than 84% of participant laboratories met 1/3TEa criteriaand 70.83%～84.47% of laboratories met 1/4TEa criteria.In HbF except for 2015,the more than 80% laboratories whose month and cumulative CVs met 1/3TEa and 1/4TEa criteria accounted for 68.42%～85.07%,respectively.Under 1/3TEa and 1/4TEa criteria,sebia capillarys 2 instrument and fully automatic hemoglobin analyzer bole Variant Ⅱ instrument group the acceptable rates of CVsabove 85%,showed good precision for HbA₂ and HbF detection.Conclusion At present,the precision level of HbA₂ and HbF need to be further improved in laboratories of China,especially HbF.Laboratory should continue to strengthen the internal quality control,establish strict internal quality system to improve detection capacity.