[化学发光免疫分析法（CLIA）和电化学发光免疫分析法（ECLIA）在献血者抗梅毒螺旋体筛查中的性能评估]

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

作者信息

Chen Jian-Feng, Li Wen-Chao, Chang Le, Cao Dan, Tang Jian-Hua, Xiao Chen, Zhang Chuan-Xing

机构信息

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.

出版信息

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2019 Feb;27(1):260-265. doi: 10.7534/j.issn.1009-2137.2019.01.042.

DOI:10.7534/j.issn.1009-2137.2019.01.042

PMID:30738480

Abstract

OBJECTIVE

To evaluate the performance of the chemiluminescence immune assay (CLIA) and the electro-chemiluminescence immuneoassay(ECLIA) for Treponemapallidum antibody（anti-TP） screening in blood donors.

METHODS

The sero-panel samples from NCCL were tested with ELISA, CLIA and ECLIA assays synchronously to evaluate their performances respectively.

RESULTS

The sensitivity and the negative predictive value of the CLIA were 100%, which were the same as one kind of ELISA, and better than the other ELISA; The specificity of the CLIA was 88.46%, the accuracy rate was 97.02%, the positive predictive value was 96.13%, which were 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 was as follows: the sensitivity was 98.93%, the negative predictive value was 96.75%, and the accuracy rate, specificity and positive predictive value of ECLIA were 97.02%, 91.54% and 97.10% respectively.

CONCLUSION

Compared with 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.

摘要

目的

评估化学发光免疫分析法（CLIA）和电化学发光免疫分析法（ECLIA）在献血者梅毒螺旋体抗体（抗-TP）筛查中的性能。

方法

同步采用酶联免疫吸附测定法（ELISA）、CLIA和ECLIA检测来自国家卫生健康委临床检验中心的血清盘样本，分别评估其性能。

结果

CLIA的灵敏度和阴性预测值均为100%，与一种ELISA相同，且优于另一种ELISA；CLIA的特异性为88.46%，准确率为97.02%，阳性预测值为96.13%，均高于两种ELISA。由于样本热灭活对ECLIA检测有显著干扰，本研究结果无法体现ECLIA的真实性能。初步结果如下：ECLIA的灵敏度为98.93%，阴性预测值为96.75%，准确率、特异性和阳性预测值分别为97.02%、91.54%和97.10%。