献血者血液中丙型肝炎病毒检测的探讨  

Discussion of Hepatitis C Virus Detection Results in Blood Donors

作　　者：莫一飞 杨文杰 詹莉 刘旭坚 MO Yifei;YANG Wenjie;ZHAN Li;LIU Xujian(Department of Laboratory,Maoming Central Blood Station,Guangdong Province,Maoming Guangdong 525000,China)

机构地区：[1]广东省茂名市中心血站检验科,广东茂名525000

出　　处：《中国卫生标准管理》2025年第4期170-174,共5页China Health Standard Management

摘　　要：目的 通过对献血者血液中丙型肝炎病毒(hepatitis c virus,HCV)的检测,探讨不同的检测方法和技术之间的差异,为血站优化血液筛查策略提供数据参考。方法 选取茂名市中心血站2019年1月—2023年12月无偿献血者血液标本379 795份为研究对象,分别统计5年间HCV检测不合格情况、酶联免疫吸附试验中2种HCV单/双侧试剂不合格率以及单侧阳性标本S/CO值的分布情况,至少1种联免疫吸附试验(enzyme linked immunosorbent assay,ELISA)试剂阳性的标本直接采用核酸检测(nucleic acid amplification test,NAT)单检模式检测,其作为补充实验,对总体结果进行综合性分析探讨。结果 5年HCV不合格率呈下降趋势(P <0.05)。试剂1不合格标本188份,占总不合格标本的31.18%(188/603);试剂2不合格标本22份,占总不合格标本的3.65%(22/603);双侧试剂不合格标本393份,占总不合格标本的65.17%(393/603);试剂1 S/CO值的P25为1.36,P75为3.18,试剂2 S/CO值的P25为1.05,P75为2.50,差异无统计学意义(P=0.065)。试剂1+试剂2-标本或者试剂1-试剂2+标本未检出HCVRNA,试剂1+试剂2+NAT+标本占42.79%,试剂1+试剂2+NAT-标本占17.31%,两者差异有统计学意义(P <0.05)。结论 HCV检测不合格率逐年呈下降趋势,试剂2比试剂1更适合现状血液筛查,抗HCV的ELISA检测和HCV-RNA的NAT是HCV感染检测的主要方法,两者相结合才是科学、可行的筛查方法。Objective To detect hepatitis c virus(HCV)in blood donors,explore the differences between different detection methods and technologies,and provide data reference for blood bank to optimize blood screening strategy.Methods A total of 379795 blood samples from voluntary blood donors in Maoming Central Blood Station from January 2019 to December 2023 were selected as the research objects. The unqualified rate of HCV detection in 5 years, the unqualified rate of two HCV single/bilateral reagents in enzyme-linked immunosorbent assay, and the distribution of S/ CO value of unilateral positive samples were statistically analyzed. Specimens positive for at least one enzyme linked immunosorbent assay (ELISA) reagent were directly detected by nucleic acid amplification test (NAT) single detection mode as a supplementary experiment. The overall results were comprehensively analyzed and discussed. Results The 5-year HCV unqualified rate showed a downward trend (P < 0.05). A total of 188 samples were unqualified by reagent 1, accounting for 31.18% (188/603) of the total unqualified samples. There were 22 unqualified samples of reagent 2, accounting for 3.65% (22/603) of the total unqualified samples. There were 393 unqualified samples of bilateral reagents, accounting for 65.17% (393/603) of the total unqualified samples. The P 25 of the S/CO value for reagent 1 was 1.36, P 75 was 3.18, and the P 25 of the S/CO value for reagent 2 was 1.05, P 75 was 2.50, the difference was not statistically significant (P =0.065). HCV- RNA were not detected in reagent 1+ reagent 2- samples or reagent 1- reagent 2+ samples, 42.79% in reagent 1+ reagent 2+NAT+ samples, 17.31% in reagent 1+ reagent 2+NAT- samples, and the differences were statistically significant (P < 0.05). Conclusion The unqualified rate of HCV detection is decreasing year by year. Reagent 2 is more suitable for the current situation of blood screening than reagent 1. Anti-HCV ELISA and HCV-RNA NAT are the main methods for the detection of HCV infection, and the combination

关 键 词：丙型肝炎病毒 酶联免疫吸附试验 核酸检测 单侧不合格率 双侧不合格率 S/CO值 

分 类 号：R446[医药卫生—诊断学]