化学发光法与电化学发光法筛查献血者梅毒抗体的检测性能评价  

Performance Evaluation of the CLIA and ECLIA for Anti-TP Screening in Blood Donors

作　　者：陈剑锋[1] 李文超[1] 常乐[2] 曹丹[1] 唐建华[1] 肖晨 张传兴[1] CHEN Jian-Feng;LI Wen-Chao;CHANG Le;CAO Dan;TANG Jian-Hua;XIAO Chen;ZHANG Chuan-Xing(Blood Center of Shandong Province,Jinan 250014,Shandong Province,China;National Center for Clinical Laboratories,Beijing Engineering Research Center of Laboratory Medicine,Beijing Hospital,National Center of Gerontology,Beijing 100088,China)

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,北京100730

出　　处：《中国实验血液学杂志》2019年第1期260-265,共6页Journal of Experimental Hematology

摘　　要：目的:评价化学发光法(CLIA)和电化学发光法(ECLIA)筛查无偿献血者梅毒抗体的性能。方法:利用卫生部临检中心提供的梅毒抗体血清盘,对比分析化学发光法、电化学发光法与酶联免疫吸附试验(ELISA)检测梅毒抗体的性能。结果:CLIA的灵敏度和阴性预期值均为100%,与1种ELISA相同,优于另一种ELISA;特异性为88. 46%,正确率为97. 02%,阳性预期值为96. 13%,均高于2种ELISA。由于血清盘样本为热灭活样本,对ECLIA梅毒抗体检测试剂盒的影响较大,结果未能评估出该试剂盒的真实性能(初步计算结果为4例假阴性,灵敏度为98. 93%,阴性预期值为96. 75%,;正确率为97. 02%,特异性为91. 54%,阳性预期值为97. 10%)。结论:CLIA对梅毒抗体的检测性能优于ELISA,具有更高的灵敏度和特异性,可用于血站筛查梅毒抗体项目;而ECLIA方法在本次实验中未能评估出试剂盒的真实性能,需进一步研究。Objective: To evaluate the performance of the chemiluminescence immune assay( CLIA) and the electrochemiluminescence immuneoassay( ECLIA) for Treponemapallidum antibody( anti-TP) screening in blood donors.Methods: The sero-panel samples from NCCL w ere tested w ith ELISA,CLIA and ECLIA assays synchronously to evaluate their performances respectively. Results: The sensitivity and the negative predictive value of the CLIA w ere100%,w hich w ere the same as one kind of ELISA,and better than the other ELISA;The specificity of the CLIA w as88. 46%,the accuracy rate w as 97. 02%,the positive predictive value w as 96. 13%,w hich w ere higher than both ELISA. Due to the significant interference of sample heat inactivation in ECLIA detection,the result can not demonstrate the true performance of ECLIA in this study. The preliminary result w as as follow s: the sensitivity w as 98. 93%,the negative predictive value w as 96. 75%,and the accuracy rate,specificity and positive predictive value of ECLIA w ere97. 02%,91. 54% and 97. 10% respectively. Conclusion: Compared w ith ELISA,the CLIA has higher sensitivity and specificity and can be used for Treponemal antibody screening in blood bank. Unfortunately,the data in this study cannot come to a conclusion for ECLIA and needs more testing.

关 键 词：抗-TP 化学发光 酶免试剂 血液筛查 

分 类 号：R457.1[医药卫生—治疗学] R759.1[医药卫生—临床医学]