HBV-DNA检测试剂的性能评估与室内质控数据评价

参照美国临床实验室标准化委员会(CLSI)文件,对临床检验使用的实时荧光定量PCR扩增检测试剂盒定量结果的精密度、正确度、定量限、线性范围及抗污染性进行评价.同时用乙型肝炎病毒核酸(HBV-DNA)试剂盒检测2016年3月~8月两个批号的质控血清HBV-DNA,并计算质控结果、标准曲线斜率、截距和相关系数的均值()、标准差(SD)和变异系数(CV).其中批内、批间精密度CV分别为1.08%~4.41%、2.17%~2.74%,达到核酸检测试剂盒的国家标准及《医学实验室质量和能力认可准则》中基因扩增检验项目分析性能标准(CV≤5%).参加2016年卫生部室间质评结果总体平均偏倚为2.03%,准确度符合卫生部质评要求.相关系数r=0.999 9,>0.98,线性关系符合要求.定量限结果符合±0.5个对数数量级的要求(评价中至少22次为阳性).本室2016年3月~8月测定的室内质控物结果对数的累积均值(±2s)为4.34(4.20~4.44),符合参考范围要求.经验证,实时荧光定量PCR HBV-DNA检测试剂盒的各项性能指标以及室内质控结果满足《医学实验室质量和能力认可准则》要求,可以为临床提供快速、准确的报告.

Performance verification and evaluation of cumulative internal quality controls data of HBV-DNA reagent kit

HBV-DNA reagent kit was used to assess the precision,accuracy,limit of quantitationand linear range according to the United States of America Clinical and Laboratory Standards Institute(CLSI).The HBV-DNA internal control sera were collected from March to August in 2016,and the mean value(),standarddeviation(SD) and coefficient variability(CV) of internal control results,slope rate,intercept and correlation coefficient of standard curves were calculated.The intra-assay precision coefficient of variation and inter-assay precision coefficient of variation are 1.08%~4.41% and 2.17%~2.74%,respectively.Both of them achieve the performance analysis standard of gene amplification test project regulated by Medical Laboratory Quality and Competence Accreditation Criteria.The overall mean bias in of Ministry of Health External Quality Assessment(EQA) was 2.03% in the first half of 2016,and the accuracy met the requirements of the Ministry of Health.The correlation coefficient is 0.999 9,the linear range met the requirement.High concentration serum was diluted to 500 IU/ml with negative serum and 22 of them were detected positive in 25 continuous assays,the limit of quantitation achieved the limit requirement.The cumulative mean(±2s) of internal controls'' logarithm was 4.34(4.20~4.48) falling within the reference range during March to August in 2016.It is verified that the technical performance of HBV-DNA reagent kit and the results of the internal quality control in our hospital fulfilled the requirement of Medical Laboratory Quality and Competence Accreditation Criteria,and established the basement for providing instant and accurate clinic reports.