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学科主题临床医学
Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study
Mahler, Michael1; Radice, Antonella2; Sinico, Renato A.1; Damoiseaux, Jan3; Seaman, Andrea1; Buckmelter, Kristen1; Vizjak, Alenka4; Buchner, Carol1; Binder, Walter L.1; Fritzler, Marvin J.5; Cui, Zhao6
关键词Autoantibodies Gbm Goodpasture&Prime s Syndrome Rapidly Progressive Crescentic Glomerulonephritis (Rpgn)
刊名NEPHROLOGY DIALYSIS TRANSPLANTATION
2012
DOI10.1093/ndt/gfr203
27期:1页:243-U295
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Transplantation ; Urology & Nephrology
研究领域[WOS]Transplantation ; Urology & Nephrology
关键词[WOS]BASEMENT-MEMBRANE ANTIBODIES ; RAPIDLY PROGRESSIVE GLOMERULONEPHRITIS ; GOODPASTURES-DISEASE ; DIFFERENTIAL-DIAGNOSIS ; CYTOPLASMIC ANTIBODIES ; SEQUENTIAL DEVELOPMENT ; PULMONARY HEMORRHAGE ; AUTOANTIBODIES ; ANCA ; NEPHRITIS
英文摘要

Background. Autoantibodies to the non-collagen region (NC1) of the alpha-3 subunit of collagen IV represent a serological hallmark in the diagnosis of Goodpasture′s syndrome (GPS). The objective of our study was to carefully analyze the performance characteristics of a novel anti-glomerular basement membrane (GBM) chemiluminescence immunoassay (CIA).

Methods. Sera from patients with GPS (n = 90) were collected from four clinical centers. Samples from different disease groups (n = 397) and healthy individuals (n = 400) were used as controls. All samples were tested for anti-GBM antibodies by a rapid, random access CIA (QUANTA Flash (TM) GBM). Most of the samples were also tested using other methods including different commercial anti-GBM IgG assays and research assays for anti-GBM IgA and IgM.

Results. The sensitivity and specificity of the novel CIA was 95.6% [95% confidence interval (CI) 89.0-98.8%] and 99.6% (95% CI 98.9-99.9%), respectively. Receiver operating characteristic analysis showed good discrimination between GPS patients and controls. The area under the curve was 0.98 (CI 0.96-1.0). The three anti-GBM antibody-positive samples from the control group were from two healthy individuals and one human immunodeficiency virus (HIV)-infected patient. All three individuals had low levels of anti-GBM antibodies [20, 24 and 25 chemiluminescent unit (CU), cutoff 20 CU]. When the results of the new CIA were compared to other methods, good agreement was observed: 95.8% (kappa = 0.92) versus EliA (TM) GBM, 97.4% (kappa = 0.95) versus both BINDAZYME (TM) Anti-GBM and QUANTA Lite (R) GBM. Anti-GBM IgA was detectable in low concentrations in patients with GPS and was associated with anti-GBM IgG but was less useful in discriminating GPS patients and controls. No discrimination was found for anti-GBM IgM.

Conclusion. The novel QUANTA Flash (TM) GBM CIA demonstrated good sensitivity and specificity and had good agreement with other methods. Our data confirm that similar to 5% of patients with GPS do not have detectable levels of anti-GBM antibodies.

语种英语
WOS记录号WOS:000299957700039
引用统计
被引频次:15[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/53301
专题北京大学第一临床医学院_肾脏内科
作者单位1.San Carlo Borromeo Hosp, Inst Microbiol, Milan, Italy
2.Univ Ljubljana, Fac Med, Inst Pathol, Ljubljana, Slovenia
3.Univ Calgary, Dept Med, Calgary, AB, Canada
4.INOVA Diagnost INC, San Diego, CA USA
5.Maastricht Univ, Clin Immunol Lab, Med Ctr, Maastricht, Netherlands
6.Peking Univ, Div Renal, Hosp 1, Inst Nephrol, Beijing 100871, Peoples R China
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GB/T 7714
Mahler, Michael,Radice, Antonella,Sinico, Renato A.,et al. Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study[J]. NEPHROLOGY DIALYSIS TRANSPLANTATION,2012,27(1):243-U295.
APA Mahler, Michael.,Radice, Antonella.,Sinico, Renato A..,Damoiseaux, Jan.,Seaman, Andrea.,...&Cui, Zhao.(2012).Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study.NEPHROLOGY DIALYSIS TRANSPLANTATION,27(1),243-U295.
MLA Mahler, Michael,et al."Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study".NEPHROLOGY DIALYSIS TRANSPLANTATION 27.1(2012):243-U295.
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