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)(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 assess a new generation test,the Cobas Taq Screen MPX Test,version 2. 0,in reducing HBV residual risk in blood donors. Methods The MPX v 2. 0 and MPX v 1. 0 were performed on Cobas s201 in pools of 6 on 165 seronegative samples in parallel processing. All NAT-reactive samples were followed-up. Discrimination tests were performed using Roche CAP / CTM Systems. Additional serology testing（ electrogenerated chemiluminescence immunoassay,ECL） were conducted to detect total anti-HBc,anti-HBs,anti-HBe and HBe. A QPCR was conducted to detect HBV viral load. A nested-PCR for genotyping was carried out. Results The positive rate of resolved pools was 66. 7%（ 10 /15） for MPX v2. 0 and75. 0%（ 9 /12） for MPX v1. 0. 14 samples were reactive on MPX v2. 0 and / or MPX v1. 0 test. All samples were found to be HBV reactive. The positive coincidence rate of 2 NAT tests was 55. 60%. The negative coincidence rate was 99. 90%. The total coincidence rate was 99. 83%（ P〉0. 05）. The follow-up study was carried out 3 months later,in which 5 HBV-yield cases were identified by MPX v1. 0 and 7 HBV-yield cases identified by MPX v2. 0. The positive coincidence rate between the first HBV DNA results and the follow up results was 75. 00%（ 6 /8） for MPX v2. 0 and 50. 00%（ 3 /6） for MPX v1. 0.Conclusion The Cobas Taq Screen MPX Test,version 2. 0,could decrease the residual risk effectively,which facilitates in enhancing the safety of blood transfusion.
出处
《中国输血杂志》
CAS
北大核心
2016年第6期574-577,共4页
Chinese Journal of Blood Transfusion
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)
