酶免工作站在肺炎链球菌抗体检测中的应用评估  

Evaluation of application of enzyme immunoassay workstation in detection of antibodies against Streptococcus pneumoniae

作　　者：周珊珊 白霜[1] 陈维欣[1] 吕敏[1] 王建 兰文文 李婧 赵丹[1] 吴疆[1] ZHOU Shanshan;BAI Shuang;CHEN Weixin;LV Min;WANG Jian;LAN Wenwen;LI Jing;ZHAO Dan;WU Jiang(Institute for Immunization and Prevention,Beijing Center for Disease Prevention and Control,Beijing 100013,China)

机构地区：[1]北京市疾病预防控制中心免疫预防所,北京100013

出　　处：《中国生物制品学杂志》2025年第2期210-214,220,共6页Chinese Journal of Biologicals

基　　金：北京市属医学科研院所公益发展改革试点项目(京医研2018-1)。

摘　　要：目的应用自动化酶免工作站替代人工检测肺炎链球菌IgG抗体,以提高检测效率。方法依据世界卫生组织(World Health Organization,WHO)肺炎链球菌荚膜多糖型特异性IgG抗体检测指导手册《Pn PS ELISA》,设置工作站试验运行流程;最大化布局工作站台面板位数以预置全部试验材料,从而提高样本检测通量和减少人工干预次数。重复检测血清PnG,验证工作站试验精密度;检测WHO肺炎链球菌校准血清盘12/278,验证工作站试验准确度;使用工作站与人工方法检测16份相同血清样本,比较方法一致性;以双列方法(WHO指导手册标准布板方法)和单列方法检测4份校准血清,比较单、双列检测结果一致性。结果通过21个板位的布局,单次可检测24份血清样本,仅需2次人工干预;血清PnG的32次检测结果变异系数(CV)低于15%;血清盘23个型别检测结果的14个型别抗体均达到75%校准血清的检测值,与理论值的误差不超过±40%,总准确度为80%。工作站与人工检测结果的一致性相关系数Pc为0.9967,工作站单列与双列检测结果的一致性相关系数为0.9998,均具有非常高的一致性。结论自动化酶免工作站具有较高的精密度和准确度,较大的检测通量,且节省人力,可用于肺炎链球菌抗体检测。单、双列对比结果为样本单列检测代替双列检测提供了实验依据。Objective To apply automated enzyme immunoassay workstation instead of manual operation to facilitate detection of Streptococcus pneumoniae(S.pneumoniae)IgG antibodies,so as to improve the detection efficiency.Methods Procedures of the assay were set up on the automated workstation according to the World Health Organization(WHO)Pneumococcal Capsular Polysaccharide Types-pecific IgG Antibody Detection Manual Pn PS ELISA.The number of working station panels was maximized to preset all reagent consumables and more samples to be tested,thereby improving the detection flux and reducing the number of manual interventions.The serum PnG was repeatedly detected to verify the test precision.The WHO S.pneumoniae international calibration serum panel 12/278 was detected to verify the accuracy of the test.To compare the consistency of workstations and manual operation,16 same serum samples were tested by manual operation and on the workstation meanwhile.Detections of four calibration serum samples were performed on the workstation by double-(WHO standard method)and single-column methods,and the consistency of the results was compared.Results With the layout of 21 plate positions,24 serum samples could be examined in one program run,requiring only 2 manual interventions.The CV of 32 detection results of serum PnG was lower than 15%.The assay results of 75%of the calibration serum panel in 14 out of 23 serotypes exhibited a percent error of 40%or less compared to the assigned values,and the total accuracy was 80%.The correlation coefficient(Pc)of agreement between workstation and manual test results was 0.9967,and the correlation coefficient of agreement between workstation single-and double-column test results was 0.9998,both of which showed high agreement.Conclusion The automated enzyme immunoassay workstation has shown high precision,accuracy and large detection throughput,which is labor-saving,and can be applied to the detection of S.pneumoniae antibodies.The results of single-and double-column assay provide experimental ba

关 键 词：酶免工作站 肺炎链球菌 IGG抗体 

分 类 号：R183.3[医药卫生—流行病学]