Kühnl Alexander, Hartwig Lea, Dähnrich Cornelia, Schlumberger Wolfgang
Institute for Experimental Immunology, EUROIMMUN Medizinische Labordiagnostika AG, Lübeck, Germany.
Front Med (Lausanne). 2022 Jul 4;9:915754. doi: 10.3389/fmed.2022.915754. eCollection 2022.
Circulating autoantibodies directed against the kidney glomerular basement membrane (GBM) antigens are important markers in the diagnosis and monitoring of autoimmune glomerulonephritides, including the classic Goodpasture's syndrome. Rapid and reliable diagnostic tools for the detection of anti-GBM autoantibodies are crucial as anti-GBM disease can progress rapidly and, if too late or incorrectly diagnosed, can have serious, even fatal consequences. The performance of the newly developed standardized chemiluminescence immunoassay (ChLIA) was evaluated in comparison with the established Anti-GBM ELISA (IgG) (EUROIMMUN). For the assessment of its diagnostic performance, sera from 67 clinically characterized anti-GBM disease patients and 221 disease controls were analyzed. The clinical sensitivity of the Anti-GBM ChLIA (IgG) reached 100% at a specificity of 98.6%. The Anti-GBM ELISA (IgG) performance was less sensitive (89.6%) without any positive findings in the control group, indicating a specificity of 100%. Both methods were homogeneous (κ = 0.901). The Anti-GBM ChLIA (IgG) represents a promising alternative tool for accurate anti-GBM assessment in routine diagnostic settings with the advantage of rapid turnaround time and fully automated random-access processing.
针对肾小球基底膜（GBM）抗原的循环自身抗体是自身免疫性肾小球肾炎诊断和监测的重要标志物，包括典型的Goodpasture综合征。由于抗GBM疾病进展迅速，如果诊断过晚或错误，可能会产生严重甚至致命的后果，因此快速可靠的抗GBM自身抗体检测诊断工具至关重要。与已建立的抗GBM ELISA（IgG）（EUROIMMUN）相比，对新开发的标准化化学发光免疫分析（ChLIA）的性能进行了评估。为了评估其诊断性能，分析了67例具有临床特征的抗GBM疾病患者和221例疾病对照的血清。抗GBM ChLIA（IgG）的临床敏感性在特异性为98.6%时达到100%。抗GBM ELISA（IgG）的性能敏感性较低（89.6%），对照组无任何阳性结果，表明特异性为100%。两种方法具有同质性（κ = 0.901）。抗GBM ChLIA（IgG）是一种很有前景的替代工具，可在常规诊断环境中准确评估抗GBM，具有周转时间短和全自动随机检测的优点。
