Due to lack of comprehensive evaluation for various detection methods for antineutrophil cytoplasmic antibody (ANCA) in Chinese population, we evaluate the diagnostic performance of 12 established analysis methods in Chinese patients having granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).
Sera were collected from 209 patients with GPA or MPA and 243 diseases controls from 15 centers. Twelve different reagents were employed for C-ANCA, P-ANCA, myeloperoxidase (MPO)-ANCA, and proteinase 3(PR3)-ANCA detection. The accuracy, sensitivity, and specificity of each method were analyzed.
The accuracy of the two indirect immunofluorescence (IIF) and two line immunoassay (LIA) was 0.838 and 0.874, 0.869, and 0.862, respectively. The accuracy of the eight quantitative antigen-specific immunoassays was varied from 0.867 to 0.967. The sensitivity of ANCA-associated vasculitis (AAV) was 0.770 and 0.761 for the two IIF, 0.727 and 0.718 for the two LIAs, respectively. For the eight quantitative antigen-specific immunoassays, the sensitivity varied from 0.79 to 0.967. The specificity was 0.897 and 0.971 for the two IIF, 0.992 and 0.988 for the two LIAs, respectively. For the eight quantitative antigen-specific immunoassays, the specificity of AAV varied from 0.963 to 0.983.
For Chinese patients suspected of having GPA and MPA, both the first-generation enzyme-linked immunosorbent assay (ELISA) and high-quality antigen-specific immunoassay can be used to detect MPO-ANCA and PR3-ANCA alone, without the combined detection with IIF to have good diagnostic performance. The chemiluminescent immunoassay (CLIA) seems to be a method worth recommending.
• Quantitative antigen-specific immunoassays can be used to detect MPO-ANCA and PR3-ANCA without IIF in Chinese.
• CLIA has the maximum AUC value and the minimum LR (−) value, which seems to be a method worth recommending.
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Csernok E, Moosig F (2014) Current and emerging techniques for ANCA detection in vasculitis. Nat Rev Rheumatol 10(8):494–501. https://doi.org/10.1038/nrrheum.2014.78
Timmeren MM, Van Peter H (2012) Pathogenesis of ANCA-associated vasculitis: recent insights from animal models. Curr Opin Rheumatol 24(1):8–14
Jarrot PA, Kaplanski G (2016) Pathogenesis of ANCA-associated vasculitis: an update. Autoimmun Rev 15(7):704–713. https://doi.org/10.1016/j.autrev.2016.03.007
Cornec D, Cornec-Le Gall E, Fervenza FC, Specks U (2016) ANCA-associated vasculitis-clinical utility of using ANCA specificity to classify patients. Nat Rev Rheumatol 12(10):570–579. https://doi.org/10.1038/nrrheum.2016.123
Bossuyt X, Cohen Tervaert JW, Arimura Y, Blockmans D, Flores-Suarez LF, Guillevin L, Hellmich B, Jayne D, Jennette JC, Kallenberg CGM, Moiseev S, Novikov P, Radice A, Savige JA, Sinico RA, Specks U, van Paassen P, Zhao MH, Rasmussen N, Damoiseaux J, Csernok E (2017) Position paper: revised 2017 international consensus on testing of ANCAs in granulomatosis with polyangiitis and microscopic polyangiitis. Nat Rev Rheumatol 13(11):683–692. https://doi.org/10.1038/nrrheum.2017.140
Savige J, Gillis D, Benson E, Davies D, Esnault V, Falk RJ, Hagen EC, Jayne D, Jennette JC, Paspaliaris B, Pollock W, Pusey C, Savage CO, Silvestrini R, van der Woude F, Wieslander J, Wiik A (1999) International consensus statement on testing and reporting of antineutrophil cytoplasmic antibodies (ANCA). Am J Clin Pathol 111(4):507–513
Li ZY, Ma TT, Chen M, Zhao MH (2016) The prevalence and management of anti-neutrophil cytoplasmic antibody-associated vasculitis in China. Kidney Dis 1(4):216–223. https://doi.org/10.1159/000441912
Damoiseaux J, Csernok E, Rasmussen N, Moosig F, van Paassen P, Baslund B, Vermeersch P, Blockmans D, Cohen Tervaert JW, Bossuyt X (2017) Detection of antineutrophil cytoplasmic antibodies (ANCAs): a multicentre European Vasculitis Study Group (EUVAS) evaluation of the value of indirect immunofluorescence (IIF) versus antigen-specific immunoassays. Ann Rheum Dis 76(4):647–653. https://doi.org/10.1136/annrheumdis-2016-209507
Csernok E, Damoiseaux J, Rasmussen N, Hellmich B, van Paassen P, Vermeersch P, Blockmans D, Cohen Tervaert JW, Bossuyt X (2016) Evaluation of automated multi-parametric indirect immunofluorescence assays to detect anti-neutrophil cytoplasmic antibodies (ANCA) in granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Autoimmun Rev 15(7):736–741. https://doi.org/10.1016/j.autrev.2016.03.010
Mahler M, Radice A, Yang W, Bentow C, Seaman A, Bianchi L, Sinico RA (2012) Development and performance evaluation of novel chemiluminescence assays for detection of anti-PR3 and anti-MPO antibodies. Clin Chim Acta 413(7–8):719–726. https://doi.org/10.1016/j.cca.2012.01.004
Mahler M, Bentow C, Serra J, Fritzler MJ (2016) Detection of autoantibodies using chemiluminescence technologies. Immunopharmacol Immunotoxicol 38(1):14–20. https://doi.org/10.3109/08923973.2015.1077461
Xin G, Zhao MH, Wang HY (2004) Detection rate and antigenic specificities of antineutrophil cytoplasmic antibodies in Chinese patients with clinically suspected vasculitis. Clin Diagn Lab Immunol 11(3):559–562. https://doi.org/10.1128/CDLI.11.3.559-562.2004
This study was supported by grants from the National Nature Science Foundation Key Research Project of China (2017YFC0909002) and the National Basic Research Program of China (No.2105CB553704).
The authors would like to express their gratitude toward Tianjin Super Biotechnology Development Co., Ltd.; Guangzhou Kangrun Biotech Co., Ltd.; Autoimmune BU., Werfen China; Shenzhen YHLO Biotech Co., Ltd.; Beijing H&J Novomed Co., Ltd.; Zeus Scientific Inc.; Shanghai Kexin Biotech Co., Ltd.; and Beijing Dacheng Biotech Co., Ltd, for providing reagents for the study.
The study was performed according to the 1997 Declaration of Helsinki of the World Medical Association and has been approved by the ethics committee of each participating center, all the participants gave written informed consent.
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Ping Zhu and Zhanguo Li share corresponding authorship.
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Zhang, W., Zheng, Z., Jia, R. et al. Evaluation of 12 different assays for detecting ANCA in Chinese patients with GPA and MPA: a multicenter study in China. Clin Rheumatol 38, 3477–3483 (2019). https://doi.org/10.1007/s10067-019-04736-6
- Antineutrophil cytoplasmic antibody
- Granulomatosis with polyangiitis
- Microscopic polyangiitis
- Multicenter studies