血液筛查室间质评中聚合酶链式反应循环阈值差异的分析  

Analysis on the difference of circulating threshold of polymerase chain reaction in blood screening of external quality assessment

作　　者：刘李栋[1] 伍晓菲[1] 贾尧[1] 黄宇闻[1] 莫琴[1] 刘鸿 马荣钠 徐忠[1] 王迅[1] LIU Lidong;WU Xiaofei;JIA Yao;HUANG Yuwen;MO Qin;LIU Hong;Ma Rongna;XU Zhong;WANG Xun(Shanghai Blood Center,Shanghai 200051,China.)

机构地区：[1]上海市血液中心,上海200051

出　　处：《中国输血杂志》2022年第9期933-936,共4页Chinese Journal of Blood Transfusion

摘　　要：目的分析血站实验室在室间质评中聚合酶链式反应(PCR)循环阈值(Ct值)的差异,对参评实验室提出质量改进建议。方法以2018~2021年血站实验室参加CITIC核酸检测血液筛查室间质评罗氏诊断试剂组的数据为来源,以HBV A亚型(400 IU/mL)、HCV 1b亚型(400 IU/mL)和HIV B基因型(500 IU/mL)3组质评标本的检测Ct值为对象,将数据先后按质评(标本)批次、试剂批次和不同实验室分组,利用方差分析的统计方法(P<0.05为差异有统计学意义),对各分组检测Ct值进行分析。结果3个项目(HBV/HCV/HIV依次按序)共有42个质评批次(13/12/17),28个试剂批次(11/8/9)和57个实验室(19/19/19)分组数据入选。质评批次分组分析表明,HBV和HCV各质评批次间无显著性差异,而除了2021年发布的2批次HIV质评标本与之前的批次存在显著性差异以外,其他HIV批次间也无显著性差异。各试剂批次分组分析表明,HCV和HIV检测各试剂批次间无显著性差异;而HBV有2批次试剂间存在显著性差异,其他试剂批次间均无显著性差异。在剔除质评批次标本分组和试剂批次标本分组中有显著性差异的数据组后,各实验室分组在HBV、HCV和HIV 3个项目中均存在极显著性差异,通过配对分析,发现有4家实验室在3个项目上与其他大多数实验室都存在显著性差异,主要表现为Ct均值偏高。结论对于质评标本检测结果正确的血站实验室,其PCR检测Ct值总体上存在差异,这种差异主要可能是由参评实验室检测能力造成。Objective To analyze the difference of circulating threshold(Ct)of polymerase chain reaction(PCR)in blood station laboratories during the external quality assessment,and to put forward suggestions for the quality improvement of participating laboratories.Methods From 2018 to 2021,the blood station laboratories participated in the external laboratory quality assessment of CITIC including blood screening items with nucleic acid testing method.The data of Roche diagnostic reagent group were used as the source,and the detected Ct values of three groups of quality control samples of HBV A subtype(400 IU/mL),HCV 1b subtype(400 IU/mL)and HIV B genotype(500 IU/mL)were used as the objects.The data were grouped according to quality control(sample)batches,reagent batches and different laboratories.Using the statistical method of variance analysis(assuming P<0.05 as significant),the detected Ct value of each group was analyzed.Results For the three items(HBV/HCV/HIV),the grouping data involving 42 batches of quality control(13/12/17),28 batches of reagent(11/8/9)and 57 laboratories(19/19/19)were selected.The grouping analysis of quality assessment batches shows that there was no significant difference between HBV and HCV quality assessment batches,and there was no significant difference between other HIV batches except the two batches of HIV quality assessment samples released in 2021.The grouping analysis of each reagent batch showed that there was no significant difference between each reagent batch for HCV and HIV detection,while there was significant difference between two batches of HBV reagents.After excluding the data groups with significant differences in the quality control batch groups and the reagent batch groups,the detected Ct value of each laboratory group had extremely significant differences in the three items of HBV,HCV and HIV.Through pairing analysis,it was found that four laboratories had significant differences with most other laboratories in the three items,mainly manifested in the high mean value of Ct

关 键 词：中国国际输血感染预防与控制项目 室间质评 核酸检测 聚合酶链式反应 循环阈值 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]