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

  • Wenjuan Zhang
  • Zhaohui Zheng
  • Rulin Jia
  • Xiangpei Li
  • Xiaoxia Zuo
  • Lijun Wu
  • Nan Shen
  • Zhijun Li
  • Yan Zhang
  • Guochun Wang
  • Feng Yu
  • Xiao Zhang
  • Shaoxian Hu
  • Miaojia Zhang
  • Xiaofeng Li
  • Shiren Sun
  • Yang Xiang
  • Yi Tao
  • Liqi Bi
  • Qin Li
  • Zhanguo LiEmail author
  • Ping ZhuEmail author
Original Article

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.

Keywords

Antineutrophil cytoplasmic antibody Detection Granulomatosis with polyangiitis Microscopic polyangiitis Multicenter studies 

Notes

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.

Compliance with ethical standards

Statement

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.

Disclosures

None.

Supplementary material

10067_2019_4736_MOESM1_ESM.docx (15 kb)
ESM 1 (DOCX 14.5 kb)
10067_2019_4736_MOESM2_ESM.docx (17 kb)
ESM 2 (DOCX 17.1 kb)

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Copyright information

© International League of Associations for Rheumatology (ILAR) 2019

Authors and Affiliations

  • Wenjuan Zhang
    • 1
    • 2
  • Zhaohui Zheng
    • 1
    • 2
  • Rulin Jia
    • 3
  • Xiangpei Li
    • 4
  • Xiaoxia Zuo
    • 5
  • Lijun Wu
    • 6
  • Nan Shen
    • 7
  • Zhijun Li
    • 8
  • Yan Zhang
    • 9
  • Guochun Wang
    • 10
  • Feng Yu
    • 11
  • Xiao Zhang
    • 12
  • Shaoxian Hu
    • 13
  • Miaojia Zhang
    • 14
  • Xiaofeng Li
    • 15
  • Shiren Sun
    • 16
  • Yang Xiang
    • 17
  • Yi Tao
    • 18
  • Liqi Bi
    • 19
  • Qin Li
    • 20
  • Zhanguo Li
    • 3
    Email author
  • Ping Zhu
    • 1
    • 2
    Email author
  1. 1.Department of Clinical Immunology, Branch of Immune Cell Biology, State Key Discipline of Cell Biology, PLA Specialized Research Institute of Rheumatology & Immunology, Xijing HospitalFourth Military Medical UniversityXi’anChina
  2. 2.National Translational Science Center for Molecular MedicineXi’anChina
  3. 3.Department of Rheumatology and ImmunologyPeking University of People’s HospitalBeijingChina
  4. 4.Department of Rheumatology and Immunology, The First Affiliated Hospital (Anhui Provincial Hospital)University of Science and Technology of China HefeiChina
  5. 5.Department of Rheumatology, Xiangya HospitalCentral South UniversityChangshaChina
  6. 6.Department of RheumatologyPeople Hospital of Xinjiang Uygur Autonomous RegionUrumchiChina
  7. 7.Department of Rheumatology, Renji HospitalMedical College of Shanghai Jiaotong UniversityShanghaiChina
  8. 8.Department of RheumatologyThe Affiliated Hospital of Bengbu Medical CollegeBengbuChina
  9. 9.Department of Rheumatology and Immunology, Tangdu HospitalFourth Military Medical UniversityXi’anChina
  10. 10.Department of Rheumatology and ImmunologyChina-Japan Friendship HospitalBeijingChina
  11. 11.Department of NephrologyPeking University of First HospitalBeijingChina
  12. 12.Department of RheumatologyGuangdong Provincial People’s HospitalGuangzhouChina
  13. 13.Department of Rheumatology and Immunology, Tongji Hospital of Tongji Medical CollegeHuazhong University of Science and technologyWuhanChina
  14. 14.Department of Rheumatology, First Affiliated HospitalNanjing Medical UniversityNanjingChina
  15. 15.Department of RheumatologyThe Second Hospital of Shanxi Medical UniversityTaiyuanChina
  16. 16.Department of Nephrology, Xijing HospitalFourth Military Medical UniversityXi’anChina
  17. 17.University Hospital of Hubei University for NationalitiesEnshiChina
  18. 18.Department of Rheumatology ImmunologyThe Second Affiliated Hospital of Guangzhou Medical CollegeGuangzhouChina
  19. 19.Department of Rheumatology and ImmunologyChina-Japan union Hospital of Jilin UniversityChangchunChina
  20. 20.Department of Rheumatology and ImmunologyYunnan Province First People’s HospitalKunmingChina

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