乙肝酶免无反应而核酸未鉴别反应性结果分析  

Analysis of the results with hepatitis B seronegative and nucleic acid testing non-discriminated reactive

作　　者：胡一钦 黄纪红 王敏 吴丹霄[1] 王晓娟[1] Hu Yiqin;Huang Jihong;Wang Min;Wu Dangxiao;Wang Xiaojuan(Blood Center of Zhejiang Province,Hangzhou 310052,China)

机构地区：[1]浙江省血液中心,杭州310052

出　　处：《中华实验和临床病毒学杂志》2023年第4期422-428,共7页Chinese Journal of Experimental and Clinical Virology

基　　金：浙江省血液中心科研项目(ZJB202303)。

摘　　要：目的分析乙型肝炎病毒表面抗原无反应性的献血者中,初始检测反应性而后续的鉴别试验或重复试验无反应性的未鉴别反应性献血者(non-discriminated reactive,NDR)的感染状态,探讨不同核酸检测系统对HBsAg^(-)/NDR是否存在检测差异性。方法对2020年1月至2022年8月献血者样本的检测结果以及反应性率进行比较,并对部分样本进行两种核酸检测系统的重复检测,分析HBsAg^(-)/HBV DNA+献血人群特征。结果通过对2020年1月至2022年8月的核酸结果分析,重复核酸检测可提高HBsAg^(-)/NDR献血者的检出,且检出率在不同的循环阈值(cycle threshold valve,Ct值)区间或不同的样本吸光度与临界值吸光度的比值(sample OD/Cutoff,S/CO值)区间存在偏移。同时将Ct值或S/CO值分组发现,在两种核酸检测系统中不同区间的检出率存在差异性(PCR:X^(2)=108.23,P<0.001,TMA:X^(2)=40.95,P<0.001),主要集中于Ct值小于38.5或S/CO值10至15之间。并对部分HBsAg^(-)/HBV DNA+献血人群分析发现,重复核酸检测对于不同年龄(X^(2)=9.38,P=0.025)、献血次数(X^(2)=22.52,P<0.001)、职业(X^(2)=24.92,P=0.002)及文化程度(X^(2)=10.37,P=0.016)的献血者存在显著性差异,而对于不同性别的献血者并无统计学差异(X^(2)=9.38,P>0.05),男性(67.50%)远多于女性。结论不同核酸检测系统对HBsAg^(-)/NDR献血者存在检测差异性,对于Ct值小于38.5、或S/CO值为10至15之间、或献血年龄在41至50岁的献血者,可结合另一检测技术提高检出率,降低HBsAg^(-)/NDR献血者的潜在病毒传播风险,保障临床用血安全。Objective Analysis of hepatitis B surface antigen negative donations,initial detection of reactivity followed by subsequent differential tests or repeat the infection status of non-discriminated reactive(NDR)unresponsive blood donors to explore whether different nucleic acid detection systems have differences in the detection of HBsAg^(-)/NDR.Methods The test result and reactivity rates of blood donor samples received from January 2020 to August 2022 were compared,and some samples were repeated for both nucleic acid testing systems,and the characteristics of the HBsAg^(-)/HBV DNA+blood donors were analyzed.Results Through the analysis of nucleic acid result from January 2020 to August 2022,repeated nucleic acid detection can improve the detection of HBsAg^(-)/NDR blood donors,and the detection rate is offset in different cycle threshold valve(Ct value)intervals or different sample absorbance to cut-off absorbance ratio(S/CO value)interval.Also grouping of Ct values or S/CO values revealed that there was variability in detection rates between intervals in the two nucleic acid detection systems(PCR:X^(2)=108.23,P<0.001,TMA:X^(2)=40.95,P<0.001),mainly concentrated in Ct values less than 38.5 or S/CO values between 10 and 15.And analysis of selected HBsAg^(-)/HBV DNA+blood donor populations revealed that repeat nucleic acid testing was found for donors of different age(X^(2)=9.38,P=0.025),number of blood donations(X^(2)=22.52,P<0.001),occupation(X^(2)=24.92,P=0.002)and education level(X^(2)=10.37,P=0.016)significant differences,while there was no statistically significant difference for blood donors by gender(X^(2)=9.38,P>0.05),with far more males(67.50%)than females.Conclusions For blood donors with a Ct value of less than 38.5,or an S/CO value between 10 and 15,or a blood donor at the age of 41 to 50 years,another detection technology can be combined to improve the detection rate,reduce the potential risk of virus transmission of HBsAg^(-)/NDR blood donors,and ensure the safety of clinical blood.

关 键 词：核酸检测 乙型肝炎病毒 血液安全 

分 类 号：R512.62[医药卫生—内科学] R457.1[医药卫生—临床医学]