两种化学发光免疫分析试剂用于血液筛查丙肝抗体的检测性能评价  

Performance evaluation of two chemiluminescence immunoassay reagents for HCV antibody in blood donors screening

作　　者：陈剑锋[1] 常乐[2] 刘虹[1] 李文超[1] 李蓬[1] CHEN Jianfeng;CHANG Le;LIU Hong;LI Wenchao;LI Peng(Blood Center of Shandong Province,Jinan 250014,China;National Center for Clinical hiboratories,Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology)

机构地区：[1]山东省血液中心,山东济南250014 [2]北京医院国家老年医学中心卫生部临床检验中心北京市临床检验工程技术研究中心

出　　处：《中国输血杂志》2021年第2期123-127,共5页Chinese Journal of Blood Transfusion

摘　　要：目的评价两种化学发光免疫分析(CLIA)试剂检测丙型肝炎病毒抗体(抗-HCV)的性能,重点探讨用于献血者筛查的可行性。方法采用CLIA、ECLIA和2种酶联免疫吸附试验(ELISA)(A为双抗原夹心法,B为间接法)试剂平行检测常规献血者标本与血清盘,比较4种试剂的灵敏度、特异性和变异系数。结果 CLIA、ECLIA、A和B试剂的灵敏度依次为99.06%(315/318)、99.69%(317/318)、99.06%(315/318)和99.69%(317/318),临床特异性分别为99.97%(2 995/2 996)、99.06%(2 994/2 996)、99.97%(2 995/2 996)和100%(2 996/2 996);ECLIA试剂的批内和批间精密度(CV均<8%)均比ELISA试剂高(ELISA批内变异系数在15%以内,批间变异系数在20%以内),CLIA试剂的精密度也基本满足要求(批内和批间精密度CV<14%)。结论在本次研究中,该ECLIA试剂检测血清盘表现出较高的灵敏度和精密性,以及对常规标本的筛查特异性均符合血液筛查的要求;该CLIA试剂具有较高的特异性,灵敏度与间接法ELISA试剂相同,可与灵敏度较高的其他试剂联合使用筛查献血者丙肝抗体。Objective Aim of this study was to evaluate performance of two chemiluminescence immunoassay(CLIA) reagents for hepatitis C virus antibodies(anti-HCV) detection, focusing on the feasibility of blood screening for blood donors. Methods The sero-panel samples from NCCL and the donor samples were tested with CLIA, ECLIA and two ELISA(A:double antigen sandwich method, B:indirect method) reagents synchronously to evaluate their performances respectively, and the sensitivity, specificity and CV of the four reagents were compared. Results CLIA, ECLIA, A and B reagents showed sensitivities of 99.06%(315/318), 99.69%(317/318), 99.06%(315/318) and 99.69%(317/318), and clinical specificities was 99.06%(315/318), 99.69%(317/318), 99.06%(315/318) and 99.69%(317/318), respectively. Between-run and within-run precision for ECLIA reagent ranged(both CV<8%) was better than two ELISA reagents(between-run: CV <15% and within-run: CV <20%), and the CLIA reagent also met the requirement in blood screening(CVs <14%). Conclusion This ECLIA reagent showed high sensitivity and good reproducibility together with acceptable specificity in routine sample screening, which proved its further application in blood screening. This CLIA reagent has high specificity and the same sensitivity as indirect ELISA reagent. This CLIA reagent could be used in combination with other reagents with high sensitivity to screen anti-HCV in blood donors.

关 键 词：丙肝抗体 化学发光法 酶联免疫吸附试验 血液筛查 

分 类 号：R446.62[医药卫生—诊断学] R512.63[医药卫生—临床医学]