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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)(P>0.05)。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。
Objective To evaluate the effect of a new generation 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. Methods A total of 5 165 cases of serological non-responsive samples were mixed with 6 replicates and detected by parallel nucleic acid using MPX v2.0 and MPX v1.0 (control) respectively. The detection results of two kinds of reagents Sexual specimens are tracked. To CAP / CTM nucleic acid quantitative detection system for nucleic acid identification test, electrochemical detection of hepatitis B serology 5, QPCR assay of HBV load, nest-PCR method of HBV genotyping. Results The resolution rates of MPX v2.0 and MPX v1.0 were 66.7% (10/15) vs 75.0% (9/12), respectively. A total of 14 samples of HBV DNA were detected by 2 kinds of reagents, and the results of nucleic acid discrimination test were HBV DNA reactivity. The positive coincidence number (5/9) (55.60% 5 151/5 156 (99.90%), with a total compliance rate of 99.83% (5 156/5 165) (P> 0.05). There were 5 cases of MPX v1.0HBV DNA reactivity and 7 cases of MPX v2.0 HBeV DNA reactivity at 3 months follow-up. The positive coincidence rates of HBV DNA and MPX v2.0 tracked by MPX v2.0 and MPX v1.0 were 75.00% (6/8) vs 50.00% (3/6). Conclusion MPX v2.0 nucleic acid combined detection reagent than the previous generation reagent can effectively reduce the residual risk of HBV transfusion, suitable for blood screening.