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™ 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™ GBM, 97.4% (kappa = 0.95) versus both BINDAZYME™ Anti-GBM and QUANTA Lite® 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™ GBM CIA demonstrated good sensitivity and specificity and had good agreement with other methods. Our data confirm that ∼5% of patients with GPS do not have detectable levels of anti-GBM antibodies. © 2011 The Author
Mahler, M., Radice, A., Sinico, R., Damoiseaux, J., Seaman, A., Buckmelter, K., et al. (2012). Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: An international multicenter study. NEPHROLOGY DIALYSIS TRANSPLANTATION, 27(1), 243-252.
Citazione: | Mahler, M., Radice, A., Sinico, R., Damoiseaux, J., Seaman, A., Buckmelter, K., et al. (2012). Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: An international multicenter study. NEPHROLOGY DIALYSIS TRANSPLANTATION, 27(1), 243-252. |
Tipo: | Articolo in rivista - Articolo scientifico |
Carattere della pubblicazione: | Scientifica |
Presenza di un coautore afferente ad Istituzioni straniere: | Si |
Titolo: | Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: An international multicenter study |
Autori: | Mahler, M; Radice, A; Sinico, R; Damoiseaux, J; Seaman, A; Buckmelter, K; Vizjak, A; Buchner, C; Binder, W; Fritzler, M; Cui, Z |
Autori: | |
Data di pubblicazione: | 2012 |
Lingua: | English |
Rivista: | NEPHROLOGY DIALYSIS TRANSPLANTATION |
Digital Object Identifier (DOI): | http://dx.doi.org/10.1093/ndt/gfr203 |
Appare nelle tipologie: | 01 - Articolo su rivista |