丙型肝炎的血液筛查检测策略对血液安全的影响  

Impact of blood screening strategies for Hepatitis C virus on blood safety

作　　者：臧亮[1] 周磊[1] 邓雪莲[1] 王新梅[1] 范亚欣[1] 梁晓华[1] ZANG Liang;ZHOU Lei;DENG Xuelian;WANG Xinmei;FAN Yaxin;LIANG Xiaohua(Dalian Blood Center,Dalian 116001,China)

机构地区：[1]大连市血液中心,辽宁大连116001

出　　处：《中国输血杂志》2022年第9期966-970,共5页Chinese Journal of Blood Transfusion

基　　金：辽宁省自然科学基金指导项目(2019-ZD-0881)。

摘　　要：目的建立合理有效的丙型肝炎病毒(HCV)血液筛查策略,降低HCV输血传播的风险,保障血液安全,提高血液筛查检测质量。方法分析大连地区2017~2021年HCV不合格情况,并对HCV抗体单试剂不合格的献血者进行跟踪检测,同时结合电化学发光免疫分析技术(ECLIA)和HCV RNA的核酸检测(NAT)结果,对HCV筛查策略进行综合评价。结果2017~2021年本中心共筛查HCV不合格血液标本851份(0.20%),HCV不合格标本数与不合格率呈下降趋势,其中抗-HCV双试剂反应性/NAT反应性(抗-HCV++/NAT+)标本不合格率呈显著性下降(P<0.05)。抗-HCV双试剂反应性/NAT无反应性(抗-HCV++/NAT-)标本血液标本共117份(0.028%);抗-HCV单试剂反应性(抗-HCV+)标本共664份,其中试剂1单独反应性(抗-HCV+/-)70份(10.54%),试剂2单独反应性(抗-HCV-/+)594份(89.46%);补充实验ECLIA检测标本340份,反应性标本122份(35.88%)。参与跟踪检测28人,检测结果仍为反应性的15人,ECLIA复测为反应性的2人。结论HCV的不合格率呈下降趋势,抗-HCV的血液筛查仍是保障血液安全的重要检测手段,应评估其与HCV RNA核酸检测的互补性。ECLIA作为新的血清学检测方法,有较高的敏感性和特异性。若只应用1种ELISA试剂对献血者进行抗-HCV检测,可能在一定程度上造成漏检。各实验室可根据条件合理选择抗-HCV的检测系统与HCV RNA的检测系统,制定和调整HCV的筛查策略。Objective To establish a reasonable and effective blood screening strategy for Hepatitis C virus(HCV),so as to reduce the risk of blood transfusion transmission,ensure blood safety and improve the quality of blood screening.Methods In order to evaluate HCV screening strategies comprehensively,the unqualified blood donations due to anti-HCV alone positivity in Dalian from 2017 to 2021 was tracked,with combined detection methods of electro-chemiluminescence immunoassay(ECLIA)and HCV-RNA nucleic acid test(NAT).Results A total of 851(0.20%)unqualified donations due to anti-HCV alone positivity were screened from 2017 to 2021,with a decreasing trend in both numbers and rate.Among them,the unqualified rate of samples with anti-HCV reactivity in both dural-ELISA-reagent and NAT decreased significantly(P<0.05).A total of 117(0.028%)samples were anti-HCV reactive in dural-ELISA-reagent but nonreactive in NAT;664 reactive in one-ELISA-reagent,with 70(10.54%)in ReagentⅠand 594(89.46%)in ReagentⅡ;122(35.88%)out of 340 donations were reactive in ECLIA.Among the 28 participants in the follow-up test,15 still were reactive in ELISA and 2 reactive in ECLIA.Conclusion Although the unqualified rate of HCV is decreasing,serological screening of anti-HCV is still an important method for ensuring blood safety,and its complementarity with HCV-RNA NAT should be evaluated.As a new serological assay,ECLIA has high sensitivity and specificity.Miss detection may occur if only one ELISA reagent is adopted for anti-HCV detection.Appropriate ELISA and NAT system for HCV screening should be reasonably chosen,and HCV screening strategy should be developed and adjusted according to the local conditions.

关 键 词：丙型肝炎病毒 筛查策略 抗-HCV 核酸检测 

分 类 号：R457.1[医药卫生—治疗学] R512.63[医药卫生—临床医学]