Author/Editor		Mahler, Michel; Radice, Antonella; Sinico, Renato A; Damoiseaux, Jan; Seaman, Andrea; Buckmelter, Kristen; Vizjak, Alenka; Buchner, Carol; Binder, Walter L; Fritzler, Marvin J
Title		Performance evaluation of a novel chemiluminescence assay for detection of anti-GBM antibodies: an international multicenter study
Type		članek
Source		Nephrol Dial Transplant
Vol. and No.		Letnik 27, št. 1
Publication year		2012
Volume		str. 243-52
Language		eng
Abstract		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(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 GBM CIA demonstrated good sensitivity and specificity and had good agreement with other methods. (Abs. trunc. at 2000 ch.)
Descriptors		AUTOANTIBODIES GOODPASTURE'S SYNDROME GLOMERULONEPHRITIS BASEMENT MEMBRANE CHEMILUMINESCENCE IGG SENSITIVITY AND SPECIFICITY ROC CURVE