A multi-center clinical study for ANA specific autoantibodies detection by chemiluminescent immunoassay
10.3760/cma.j.issn.1009-9158.2017.08.011
- VernacularTitle:应用化学发光法检测抗核抗体特定靶抗原/抗体的临床多中心研究
- Author:
Chaojun HU
;
Jing LUO
;
Shulan ZHANG
;
Chuiwen DENG
;
Xin ZHANG
;
Like ZHAO
;
Qinglin PENG
;
Ping ZHU
;
Cibo HUANG
;
Guochun WANG
;
Shengyun LIU
;
Yongfei FANG
;
Xiaosan CHEN
;
Le LIU
;
Qingchun LI
;
Jiyang LI
;
Mengtao LI
;
Xiaofeng ZENG
- Keywords:
Multi center study;
Antibody,anti-nuclear;
Lupus erythematosus,systemic;
Sj(o)gren′s syndrome;
Enzyme-linked immunosorbent assay
- From:
Chinese Journal of Laboratory Medicine
2017;40(8):602-608
- CountryChina
- Language:Chinese
-
Abstract:
Objective To evaluate the clinical performance of chemiluminescent immunoassay (CLIA) on anti-nuclear antibody(ANA) specific autoantibodies testing.Methods A multi-center clinical study A total of 811 Sera samples were collected from 6 collaborating hospitals during the period of April to July 2016, and tested with CLIA and line immunoassay (LIA) in parallel for autoantibodies to ribonucleoprotein(RNP), smith antigen(Sm), SSA/Ro60,SSB/La, centromere protein B(CENPB), double-stranded DNA(dsDNA), nucleosome(Nuc), and ribosome P protein(Rib-P).The positive rate,specificity and qualitative coincidence rate for each antibody between CLIA and LIA methods were analyzed.All discrepant samples for systemic lupus erythematosus (SLE) highly specific autoantibodies (including anti-Sm, dsDNA, Nuc and Rib-P) were retested by enzyme linked immunosorbent assay (ELISA) and further analyzed with SLE disease cohort using McNemar test.Results The positive rate and specificity of CLIA and LIA for antibodies to ANA specific antigens were comparable.Excellent qualitative coincidence were found between CLIA and LIA for the detection of anti-RNP, SSA/Ro60, SSB/La and CENPB (Kappa>0.75), while the coincidence rate foranti-Sm, dsDNA, Nuc and Rib-P detection were moderate (0.4
