A new chemiluminescence immunoassay for phospholipase A2 receptor 1 autoantibodies allows early identification of autoantibody recurrence in patients with membranous nephropathy

TY - JOUR

T1 - A new chemiluminescence immunoassay for phospholipase A2 receptor 1 autoantibodies allows early identification of autoantibody recurrence in patients with membranous nephropathy

AU - Hoxha, Elion

AU - Stahl, Rolf

AU - Reinhard, Linda

AU - Kühnl ,

AU - Schlumberger ,

AU - Dähnrich ,

PY - 2021/4

Y1 - 2021/4

N2 - BackgroundCirculating autoantibodies against the M-type phospholipase A2 receptor 1 (PLA2R1) are important biomarkers in membranous nephropathy (MN), supporting the diagnosis and the clinical monitoring of patients. Standardized recombinant cell-based indirect immunofluorescence assay (RC-IFA) and enzyme-linked immunosorbent assay (ELISA) are widely established for the detection of anti-PLA2R1 autoantibodies (PLA2R1-ab). The RC-IFA provides higher sensitivity than the ELISA, but lacks exact graduated quantification of antibody levels. In this study, we evaluated the diagnostic performance of a novel PLA2R1-ab immunoassay based on chemiluminescence (ChLIA) by comparing it to RC-IFA and ELISA in samples from patients with MN with different diagnostic scenarios.MethodsSerum samples from patients with biopsy-proven MN and disease controls were analyzed for PLA2R1-ab by ChLIA, ELISA, and RC-IFA.ResultsThe ChLIA demonstrated almost perfect agreement with RC-IFA for the identification of patients with PLA2R1-associated MN, while additionally allowing fine-graduated quantification of PLA2R1-ab levels. In patients with a relapse of MN, the ChLIA allowed an earlier detection of PLA2R1-ab recurrence by at least 3 months in 63% of cases compared with the ELISA.ConclusionsThe PLA2R1-ab ChLIA had the same excellent diagnostic performance as the RC-IFA and outperformed the ELISA in the diagnosis of MN and the early identification of relapses. It thus presents a favorable tool for accurate PLA2R1-ab assessment in routine diagnostic settings, while enabling fast processing and fully automated random-access implementation.

AB - BackgroundCirculating autoantibodies against the M-type phospholipase A2 receptor 1 (PLA2R1) are important biomarkers in membranous nephropathy (MN), supporting the diagnosis and the clinical monitoring of patients. Standardized recombinant cell-based indirect immunofluorescence assay (RC-IFA) and enzyme-linked immunosorbent assay (ELISA) are widely established for the detection of anti-PLA2R1 autoantibodies (PLA2R1-ab). The RC-IFA provides higher sensitivity than the ELISA, but lacks exact graduated quantification of antibody levels. In this study, we evaluated the diagnostic performance of a novel PLA2R1-ab immunoassay based on chemiluminescence (ChLIA) by comparing it to RC-IFA and ELISA in samples from patients with MN with different diagnostic scenarios.MethodsSerum samples from patients with biopsy-proven MN and disease controls were analyzed for PLA2R1-ab by ChLIA, ELISA, and RC-IFA.ResultsThe ChLIA demonstrated almost perfect agreement with RC-IFA for the identification of patients with PLA2R1-associated MN, while additionally allowing fine-graduated quantification of PLA2R1-ab levels. In patients with a relapse of MN, the ChLIA allowed an earlier detection of PLA2R1-ab recurrence by at least 3 months in 63% of cases compared with the ELISA.ConclusionsThe PLA2R1-ab ChLIA had the same excellent diagnostic performance as the RC-IFA and outperformed the ELISA in the diagnosis of MN and the early identification of relapses. It thus presents a favorable tool for accurate PLA2R1-ab assessment in routine diagnostic settings, while enabling fast processing and fully automated random-access implementation.

U2 - 10.1016/j.ekir.2020.12.034

DO - 10.1016/j.ekir.2020.12.034

M3 - SCORING: Journal article

VL - 6

SP - 928

EP - 935

JO - KIDNEY INT REP

JF - KIDNEY INT REP

SN - 2468-0249

IS - 4

ER -