化学发光法检测EB VCA和EB EA IgA的方法学性能评价  

Evaluation of the Methodological Performance of Chemiluminescent Meth⁃ods for the Detection of EB VCA and EB EA IgA

作　　者：李蔼文[1] 王楠[1] 邓超[1] LI Aiwen;WANG Nan;DENG Chao(Department of Laboratory,Guangdong Second Hospital of Traditional Chinese Medicine,Guangzhou,Guangdong Prov‐ince,510095 China)

机构地区：[1]广东省第二中医院检验科,广东广州510095

出　　处：《系统医学》2023年第21期36-38,50,共4页Systems Medicine

摘　　要：目的对新产业MAGLUMI X8检测系统应用化学发光法检测EB VCA和EB EA IgA的分析性能进行方法学评价。方法选取2020年4—6月到中山大学附属肿瘤医院就诊的患者和体检人群各20例为研究对象,并收集其全血标本。分为鼻咽癌(nasopharyngeal cancer,NPC)组(经病理诊断确诊的鼻咽癌患者20例)和健康对照(healthy control,HC组)(健康体检人群20例),参考美国临床实验室标准化协会(Clinical Laboratory Standardization Institute,CLSI)系列文件及国内卫生部行业标准,制定方法学评价方案,通过MAGLUMI X8检测系统测定EB VCA和EB EA IgA的精密度、敏感性与特异性、方法学比对、线性范围和参考区间。结果EB VCA IgA低、高值质控品分析总精密度CV分别为3.978%和2.337%,EB EA IgA低、高值质控品分析总精密度CV分别为6.078%和4.131%;EBV VCA IgA和EBV EA IgA血清学检测结果针对鼻咽癌样本检测阳性率(敏感性)分别为100%和86.36%,累计阳性率(敏感性)达100%,针对体检样本检测的特异性是95.24%;针对所有试验样本,VCA IgA临床准确性为97.56%;EA IgA准确性为90.70%。两者联合检测可以达到100%;EB VCA IgA与EBV EA IgA线性相关系数均≥0.95,线性范围验证通过。结论新产业MAGLUMI X8检测系统测定EB VCA和EB EA IgA的方法学性能良好,能够满足临床检测的需要。Objective To evaluate the methodological performance of the analytical performance of the new industry MAGLUMI X8 detection system in the application of chemiluminescence method for the detection of EB VCA and EB EA IgA.Methods Selected 20 patients and 20 physical examination people from the Cancer Hospital Affiliated to Sun Yat-sen University from April to June in 2020 as the research objects,and collect their whole blood samples.They were divided into nasopharyngeal carcinoma group(NPC),20 cases of nasopharyngeal cancer patients confirmed by pathological diagnosis and healthy control group(HC),20 cases of healthy physical examination population.With ref‐erence to the American Clinical Laboratory Standardization Institute(CLSI)series of documents and the industry stan‐dards of the Ministry of Health in China,a methodological evaluation plan was formulated to determine the precision,sensitivity and specificity,methodological comparison,linear range and reference interval of EB VCA and EB EA IgA by the MAGLUMI X8 assay system.Results The total precision CVs of EB VCA IgA low and high QC analyses were 3.978%and 2.337%,respectively,and those of EB EA IgA low and high QC analyses were 6.078%and 4.131%,re‐spectively.The EBV VCA IgA and EBV EA IgA serology results were 100%and 86.36%positive(sensitivity)for na‐sopharyngeal carcinoma samples,respectively,with a cumulative positive(sensitivity)of 100%,and the specificity of the test for physical examination samples was 95.24%.For all samples tested,the clinical accuracy was 97.56%for VCA IgA and 90.70%for EA IgA.The combination of the two tests can achieve 100%.The linear correlation coeffi‐cients of EB VCA IgA and EBV EA IgA were≥0.95,and the linear range validation was passed.Conclusion The methodological performance of the new industry MAGLUMI X8 detection system for the determination of EB VCA and EB EA IgA is good,and it can meet the needs of clinical testing.

关 键 词：化学发光法 EB病毒衣壳抗原抗体 EB病毒早期抗原抗体 方法学性能评价 

分 类 号：R714[医药卫生—妇产科学]