核酸检测试剂cobas MPX v2.0降低输血HBV残余风险的评估

发布时间：2018-02-21 19:49

本文关键词： 核酸检测血液筛查 HBV 输血残余风险追踪检测 MPX v. MPX v.　出处：《中国输血杂志》2016年06期 　论文类型：期刊论文

【摘要】：目的评估新一代核酸检测试剂cobas Taq Screen MPX Test,v2.0(MPX v2.0)应用于献血者血液HBV筛查中降低输血残余风险的效果。方法对5 165例血清学无反应性标本以6人份混样模式,分别采用试剂MPX v2.0与MPX v1.0(对照)做平行核酸检测;对2种(代)试剂检出的反应性标本进行追踪。以CAP/CTM核酸定量检测系统做核酸鉴别试验、电化学发光法做乙肝血清学5项检测、QPCR法测定HBV载量、巢氏-PCR法做HBV基因分型。结果 MPX v2.0与MPX v1.0的拆分阳性率分别为66.7%(10/15)vs 75.0%(9/12)。2种试剂共检出14例HBV DNA反应性标本,核酸鉴别试验结果均为HBV DNA反应性;2种试剂阳性符合数(率)为5/9个(55.60%),阴性符合数(率)为5 151/5 156个(99.90%),总符合率为99.83%(5 156/5 165)(P0.05)。随访3个月时有5例MPX v1.0HBV DNA反应性,7例MPX v2.0HBV DNA反应性;MPX v2.0与MPX v1.0追踪检测的HBV DNA结果与初次检测结果阳性符合率分别为75.00%(6/8)vs 50.00%(3/6)。结论 MPX v2.0核酸联合检测试剂较上一代试剂可有效降低HBV输血残余风险,适合血液筛查。
[Abstract]:Objective to evaluate the effect of cobas Taq Screen MPX test v2.0 (MPX v2.0) on reducing the residual risk of blood transfusion in blood HBV screening of blood donors. MPX v2.0 and MPX v1.0 (control) were used to detect parallel nucleic acids respectively, and the reactive specimens detected by two kinds of reagents were tracked. Nucleic acid identification tests were performed by CAP/CTM nucleic acid quantitative detection system. Electrochemiluminescence assay (ECL) was used to detect the HBV load of hepatitis B serology and HBV genotyping was performed by nested PCR. Results the positive rates of MPX v2.0 and MPX v1.0 were 66.7 / 15 / 15 vs 75.0 / 12.2 reagents, respectively, and 14 HBV DNA reactive specimens were detected. The results of nucleic acid identification test were all positive coincidence number of HBV DNA reactivity reagents, the positive coincidence rate was 5/9, the negative coincidence rate was 5 151 / 5156, the total coincidence rate was 99.83 / 5#number1# 165P 0.050.There were 5 cases of MPX v 1.0HBV DNA reactivity in 7 cases at 3 months follow-up. The positive coincidence rates of HBV DNA and MPX v1.0 were 75.00 / 8 vs 50.003 / 6 respectively. Conclusion MPX v2.0 combined nucleic acid assay can effectively reduce the residual risk of HBV blood transfusion compared with the previous one. [WT5HZ] [WT5BZ] [WT5 "BZ] [WT5" BZ] the positive rate of HBV DNA is 75.00% / 8 / 8 vs 50.003 / 6 / 6 respectively. Suitable for blood screening.
【作者单位】：深圳市血液中心;
【基金】：深圳市科技创新委员会项目(JCYJ20140403093211510) 深圳市科卫生计生系统科研项目(201401074)
【分类号】：R446.6

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