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Evaluation of 12 different assays for detecting ANCA in Chinese patients with GPA and MPA: a multicenter study in China

Abstract

Objective

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).

Methods

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.

Results

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.

Conclusion

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.

Key points
• 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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Acknowledgments

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.

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Correspondence to Zhanguo Li or Ping Zhu.

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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

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Keywords

  • Antineutrophil cytoplasmic antibody
  • Detection
  • Granulomatosis with polyangiitis
  • Microscopic polyangiitis
  • Multicenter studies