Performance Evaluation of the CLIA and ECLIA for Anti-TP Screening in Blood Donors.
10.7534/j.issn.1009-2137.2019.01.042
- Author:
Jian-Feng CHEN
1
;
Wen-Chao LI
1
;
Le CHANG
2
;
Dan CAO
1
;
Jian-Hua TANG
1
;
Chen XIAO
1
;
Chuan-Xing ZHANG
3
,
4
Author Information
1. Blood Center of Shandong Province, Jinan 250014, Shandong Province, China.
2. National Center for Clinical Laboratories, Beijing Engineering Research Center of Laboratory Medicine， Beijing Hospital，National Center of Gerontology, Beijing 100088, China.
3. Blood Center of Shandong Province, Jinan 250014, Shandong Province, China.E-mail: zhangchuanxing@
4. com.
- Publication Type:Journal Article
- MeSH:
Blood Donors;
Enzyme-Linked Immunosorbent Assay;
Humans;
Luminescence;
Luminescent Measurements;
Sensitivity and Specificity
- From:
Journal of Experimental Hematology
2019;27(1):260-265
- CountryChina
- Language:Chinese
-
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.
