血液核酸筛查系统在不同检测筛查模式下的乙肝检测结果分析及评价  

Analysis and evaluation of hepatitis B test results of blood nucleic acid testing under different screening modes

作　　者：胡一钦 黄纪红 王敏 丰芳君 刘晋辉[1] 董杰[1] HU Yiqin;HUANG Jihong;WANG Min;FENG Fangjun;LIU Jinhui;DONG Jie(Blood Center of Zhejiang Province,Hangzhou 310052,China)

机构地区：[1]浙江省血液中心,浙江杭州310052

出　　处：《中国输血杂志》2024年第9期1030-1035,共6页Chinese Journal of Blood Transfusion

基　　金：浙江省血液中心科研项目(ZJB202303)。

摘　　要：目的通过分析罗氏Cobas s 201的血液核酸检测(NAT)结果评估其对HBV的检测效果。方法将检测结果根据酶联免疫吸附试验(ELISA)和NAT混合检测(MP)、NAT单样本检测(ID)以及重复NAT单样本检测(rID)分组,分为ELISA+/NAT(ID)+、ELISA+/NAT(rID)+、ELISA-/NAT(ID)+、ELISA-/NAT(rID)+4组进行统计分析,探讨重复NAT对反应性结果的检出是否存在差异,对于不同ELISA结果的NAT反应性标本的循环阈值(cycle threshold,Ct)与核酸检出率的关联性。再通过补充试验,包括其他方法学的NAT系统和化学发光血清学标志物检测,进一步分析献血者的真实感染情况。结果766293份献血者标本中共有1691组HBV NAT(MP)+,其中1418组(83.86%)检出反应性结果(1418份HBV NAT+,7090份NAT-),仍有273组(16.14%)经重复检测仍未检出[共计1638份NAT-,Ct(MP):39.49±3.62]。HBV NAT+中,881份(62.13%)ELISA+/NAT(ID)+,19份(1.34%)ELISA+/NAT(rID)+,451份(31.81%)ELISA-/NAT(ID)+,67份(4.72%)ELISA-/NAT(rID)+。对于不同ELISA结果的标本,重复NAT对HBV的检出存在差异(P<0.05)。各组间Ct(ID)值仅ELISA+/NAT(rID)+和ELISA-/NAT(ID)+、ELISA+/NAT(rID)+和ELISA-/NAT(rID)+2组比较无差异(P>0.05),其余各组间两两比较,均有差异(P<0.05)。对228份ELISA-/NAT(MP)+(ID)-进行补充试验,有56份(24.56%)经化学发光检测HBsAg+和7份(3.07%)经其他NAT系统检出反应性。剩余221份(96.93%)NAT-标本中,53份(23.98%)HBsAg+的献血者可能存在慢性感染,40份(18.10%)抗-HBe+和(或)抗-HBc+的献血者可能存在既往感染,其余128份(57.92%)均无反应性的献血者为NAT(MP)假反应性,且各组间抗-HBs含量差异较大(P<0.05)。结论重复NAT对不同反应性类别或不同血清学结果的献血者标本存在差异性检出,尤其在一定区间范围内,对于ELISA-标本进行重复NAT可明显提高检出率。Ct值可辅助评估NAT系统的稳定性和准确性。对于ELISA-/NAT(MP)+(ID)-献血者,结合其他高灵敏度的检测手段可降低病毒残余风险,保障Objective To evaluate the effectiveness of Roche Cobas s 201 in detecting HBV by analyzing its blood nucleic acid testing(NAT)results.Methods The results were grouped according to the enzyme-linked immunosorbent assay(ELISA)and NAT minipool test(MP),NAT individual test(ID)and repeated NAT ID test(rID),and categorized into 4 groups as ELISA+/NAT(ID)+,ELISA+/NAT(rID)+,ELISA-/NAT(ID)+and ELISA-/NAT(rID)+.The data were statistically analyzed to explore whether there was a difference in the detection of reactive results by repeated NAT,and the correlation between cycle threshold(Ct)and nucleic acid detection rate for NAT-reactive samples with different ELISA results.The true infection status of blood donors was further analyzed by supplementary tests,including NAT systems and chemiluminescence serological marker assays using other methodologies.Results A total of 1691 groups of 766293 blood donor samples were HBV NAT(MP)+,of which 1418 groups(83.86%)were detected with reactive results(1418 HBV NAT+,7090 NAT-),and there were still 273 groups(16.14%)that remained undetected after repeated testing[a total of 1638 NAT-,Ct(MP):39.49±3.62].Of the HBV NAT+,881(62.13%)were ELISA+/NAT(ID)+,19(1.34%)were ELISA+/NAT(rID)+,451(31.81%)were ELISA-/NAT(ID)+,and 67(4.72%)were ELISA-/NAT(rID)+.For samples with different ELISA results,difference was found in the detection of HBV by repeated NAT(P<0.05).There was no difference in Ct(ID)values between groups ELISA+/NAT(rID)+and ELISA-/NAT(ID)+,and groups ELISA+/NAT(rID)+and ELISA-/NAT(rID)+(P>0.05),but there were significant differences between other groups compared pairwise(P<0.05).Supplementary tests were performed on 228 ELISA-/NAT(MP)+(ID)-samples,56(24.56%)were reactive by chemiluminescent detection of HBsAg+and 7(3.07%)by other NAT systems.Among the remaining 221 NAT-samples/donors(96.93%),53(23.98%)HBsAg+donors were likely to have chronic infection,40(18.10%)anti-HBe+and/or anti-HBc+donors might have previous infections,and the remaining 128(57.92%)donors who were non-reactive we

关 键 词：血液筛查 核酸检测 血液安全 

分 类 号：R457.1[医药卫生—治疗学] R446[医药卫生—临床医学]