Establishment and clinical evaluation of dry fluorescent luminescencemethod for detection of antibodies to hepatitis C virus
10.13303/j.cjbt.issn.1004-549x.2022.01.005
- VernacularTitle:丙型肝炎病毒抗体干式荧光发光检测方法的建立及临床评价
- Author:
Shan HUANG
1
;
Xiruo SUN
2
;
Songqin LYU
1
;
Baomei XU
1
;
Lei NIE
1
;
Xiaofei LI
1
;
Xiaoyan FENG
2
;
Yina WANG
2
;
Chaonan WANG
3
;
Ling ZHANG
3
Author Information
1. The Third people’s Hospital of Kunming(Clinical Centre for Infectious Diseases in Yunnan province), Kunming 650041, China
2. Shanghai Rongsheng Biotech Co., Ltd.
3. Medical Institute of Oriental Ocean (Beijing)
- Publication Type:Journal Article
- Keywords:
hepatitis C virus antibody detection;
dry fluorescent luminescence method;
dominant epitope chimeric HCV antigen;
technical performance evaluation
- From:
Chinese Journal of Blood Transfusion
2022;35(1):17-21
- CountryChina
- Language:Chinese
-
Abstract:
【Objective】 To establish a dry fluorescent luminescence method for the detection of antibodies to hepatitis C virus (HCV) and evaluate its clinical application. 【Methods】 Anti-HCV antibody was detected by double-antigen sandwich dry fluorescent luminescence method established using multi-epitope chimeric antigen. The established method was used to detect national reference samples(positive 20, negative 20), and a total of 349 clinical samples, including 108 HCV patients, 36 patients with other diseases and 205 healthy individuals, which were tested in parallel with enzyme-linked immunoassay (ELISA) to evaluate the performance of the established method. 【Results】 The concordance rate of positive and negative(each 20) reference samples were both 100% (20/20), and the CV of precision reference sample was 9.16%, which met the requirements of national reference samples. In clinical performance evaluation, the AUC value was 0.984, and the sensitivity and specificity of the dry fluorescent luminescence method were 96.30% (104/108) and 96.27% (233/241). The overall concordance rate between dry fluorescent luminescence method and ELISA was 97.71% (341/349) (Kappa=0.952). 【Conclusion】 The dry fluorescence luminescence method of HCV antibody is simple and rapid, with high sensitivity and high specificity, and can be used in clinical application.
