The analytical performance evaluation of BioPlexTM 2200 automatic immunoassay analyzer for the determination of anti-cyclic citrullinated peptide antibodies

doi:10.3969/j.issn.1673-8640.2014.02.015

Abstract

Abstract:

Objective To evaluate the analytical performance of BioPlex^TM 2200 automatic immunoassay analyzer (Bio Plex^TM 2200) for the determination of anti-cyclic citrullinated peptide (CCP) antibodies, and assess its clinical application significance. Methods Serum samples from 65 patients with rheumatoid arthritis(RA), 46 non-RA patients(31 patients with various autoimmune diseases and 15 patients with osteoarthritis)and 20 healthy subjects were collected. Their anti-CCP antibodies were determined by Bio Plex^TM 2200.The analytical performance and preliminary clinical application significance of BioPlex^TM 2200 were evaluated. The consistency was evaluated between BioPlex^TM 2200 and Roche Elecsys assay. Results The within-run and inter-day precisions of high, moderate and low concentrations of sera were 2.4% / 4.5%, 3.3% / 3.5% and 4.4%/5.6%, respectively. BioPlex^TM 2200 could be evaluated as liner in the range of 0.5-294.6 U/mL through polynomial regression analysis. The consistency between BioPlex^TM 2200 and Roche Elecsys assay was good (kappa value was 0.873). The optimal cut-off valuefor the diagnosis of anti-CCP antibodies was 2.3 U/mL by receiver operating characteristic (ROC) curve, the diagnostic sensitivity was 80.0%, and the diagnostic specificity was 98.5%. Conclusions BioPlex^TM 2200 has a good analytical performance, and it can be applied to the clinical diagnosis of RA and the monitoring of treatment efficacy.

Key words: Anti-cyclic citrullinated peptide antibody, Rheumatoid arthritis, Precision, Linearity, Receiver operating characteristic curve

CLC Number:

R446.1

ZHAO Ying, HUANG Fei, SONG Binbin, GUO Wei, PAN Baishen.. The analytical performance evaluation of BioPlex^TM 2200 automatic immunoassay analyzer for the determination of anti-cyclic citrullinated peptide antibodies[J]. , 2014, 29(2): 153-157.

References

[1] Symmons DP.Epidemiology of rheumatoid arthritis: determinants of onset, persistence and outcome[J].Best Pract Res Clin Rheumatol, 2002, 16(5):707-722.
[2] 叶伟胜, 张铁良.类风湿关节炎流行病学进展[J].国际骨科学杂志, 2009, 30(3):144-147.
[3] Sokka T.Work disability in early rheumatoid arthritis[J].Clin Exp Rheumatol, 2003, 21(5 Suppl 31):S71-S74.
[4] Pincus T, Gibofsky A, Weinblatt ME.Urgent care and tight control of rheumatoid arthritis as in diabetes and hypertension: better treatments but a shortage of rheumatologists[J].Arthritis Rheum, 2002, 46(4):851-854.
[5] Breedveld FC, Emery P, Keystone E, et al.Infliximab in active early rheumatoid arthritis [J].Ann Rheum Dis, 2004, 63(2):149-155.
[6] Manivelavan D, CKV. Anti-cyclic citrullinated peptide antibody: an early diagnostic and prognostic biomarker of rheumatoid arthritis[J].J Clin Diagn Res, 2012, 6(8):1393-1396.
[7] 秦望森, 邓予晖, 许泼实. RF、抗RA33抗体、抗CCP抗体联合检测在类风湿关节炎诊断中的应用[J]. 检验医学, 2011, 26(10): 703-705.
[8] 王玉俊, 陈洁, 万年红, 等. 抗环瓜氨酸肽抗体对类风湿性关节炎早期诊断的应用研究[J]. 检验医学, 2011, 26(7): 440-443.
[9] Forslind K, Ahlmén M, Eberhardt K, et al.Prediction of radiological outcome in early rheumatoid arthritis in clinical practice: role of antibodies to citrullinated peptides (anti-CCP) [J].Ann Rheum Dis, 2004, 63(9):1090-1095.
[10] Alessandri C, Bombardieri M, Papa N, et al.Decrease of anti-cyclic citrullinated peptide antibodies and rheumatoid factor following anti-TNF alpha therapy (infliximab) in rheumatoid arthritis is associated with clinical improvement[J].Ann Rheum Dis, 2004, 63(10): 1218-1221.
[11] Vander Cruyssen B, Hoffman IE, Zmierczak H, et al.Anti-citrullinated peptide antibodies may occur in patients with psoriatic arthritis[J].Ann Rheum Dis, 2005, 64(8):1145-1149.
[12] Ezzat WM, Raslan HM, Aly AA, et al.Anti-cyclic citrullinated peptide antibodies as a discriminating marker between rheumatoid arthritis and chronic hepatitis C-related polyarthropathy[J].Rheumatol Int, 2011, 31(1):65-69.
[13] 中华医学会风湿病学分会.类风湿关节炎诊断及治疗指南[J].中华风湿病学杂志, 2010, 14(4):265-270.
[14] Kaul R, Johnson K, Scholz H, et al.Performance of the BioPlex 2200 autoimmune vasculitis kit[J].Auto-immun Rev, 2009, 8(3):224-227.
[15] Shovman O, Gilburd B, Barzilai O, et al.Evaluation of the BioPlex 2200 ANA screen: analysis of 510 healthy subjects: incidence of natural/predictive autoantibodies[J].Ann N Y Acad Sci, 2006, 1050:380-388.
[16] 程涛, 王慧煜, 梅琳, 等.悬浮芯片技术应用进展[J].生物技术通报, 2011, 27(9):48-51.
[17] 吴炯, 吴蕙, 郭玮, 等.线性评价方案的发展和临床应用[J].检验医学, 2006, 21(6):573-575.
[18] Sharif SK, Eghbal S, Gharibdoost F, et al.Comparative study of anti-CCP and RF for the diagnosis of rheumatoid arthritis [J].APLAR Journal of Rheumatology, 2007, 10(2):121-124.
[19] Bizzaro N, Mazzanti G, Tonutti E, et al.Diagnostic accuracy of the anti-citrulline antibody assay for rheumatoid arthritis [J].Clin Chem, 2001, 47(6):1089-1093.
[20] Van Gaalen FA, Visser H, Huizinga TW.A comparison of the diagnostic accuracy and prognostic value of the first and second anti-cyclic citrullinated peptides (CCP1 and CCP2) autoantibody tests for rheumatoid arthritis[J].Ann Rheum Dis, 2005, 64(10):1510-1512.
[21] Riedemann JP, Muoz S, Kavanaugh A.The use of second generation anti-CCP antibody (anti-CCP2) testing in rheumatoid arthritis-a systematic review[J].Clin Exp Rheumatol, 2005, 23(5 Suppl 39):S69-S76.
[22] Wyness SP, La′ulu SL, Hunsaker JJ, et al.Perfor-mance characteristics of three random access cyclic citrullinated peptide antibody assays[J].Clin Chim Acta, 2010, 411(5-6):428-432.
[23] Rottmann M.Anti-CCP: challenges in quantifying auto-antibodies and creating international reference materials[J].Scand J Clin Lab Invest Suppl, 2010, 242:44-45.
[24] Waterboer T, Sehr P, Pawlita M.Suppression of non-specific binding in serological Luminex assays[J].J Immunol Methods, 2006, 309(1-2):200-204.
[25] Mediwake R, Isenberg D, Schellekens G, et al.Use of anti-citrullinated peptide and anti-RA33 antibodies in distinguishing erosive arthritis in patients with syste-mic lupus erythematosus and rheumatoid arthritis[J].Ann Rheum Dis, 2001, 60(1):67-68.
[26] Damin-Abrego G, Cabiedes J, Cabral AR.Anti-citrullinated peptide antibodies in lupus patients with or without deforming arthropathy[J].Lupus, 2008, 17(4):300-304.

The analytical performance evaluation of BioPlex^TM 2200 automatic immunoassay analyzer for the determination of anti-cyclic citrullinated peptide antibodies

RichHTML

PDF (PC)

Knowledge

Abstract

Cite this article

share this article

References

Related Articles 15

Recommended Articles

Metrics

[1]	WANG Wei, ZHANG Zhixin, ZHANG Chuanbao, ZHOU Weiyan, WANG Zhiguo. Establishment of allowable total error，allowable imprecision and allowable bias for 22 endocrine analytes [J]. Laboratory Medicine, 2023, 38(8): 707-712.
[2]	LIU Qingyang, YUAN Jianming, XIA Jinjun, JIANG Fengying, WANG Qiubo, WANG Xiaoming. CXCL9 as a potential diagnostic marker of rheumatoid arthritis based on GEO database and experimental verification [J]. Laboratory Medicine, 2023, 38(12): 1121-1129.
[3]	GAO Feng. Research progress of new tumor molecular markers in the age of precision medicine：from accurate diagnosis to precision chemotherapy [J]. Laboratory Medicine, 2022, 37(4): 309-312.
[4]	LI Xiaobo, PU Zhifei, WU Xiaoqi, LIU Yangyang, XIE Xuanbo, SHAN Hanming, YU Jiaping. Application of CLSI EP06-Ed2 in the linear verification of quantitative measurement procedures [J]. Laboratory Medicine, 2022, 37(3): 230-234.
[5]	CHEN Yujia, SUN Zhiyong, WANG Shaojing, YANG Jiangtao, WU Benqing. Application of self-made drying device in the preparation of dried blood filter paper samples [J]. Laboratory Medicine, 2021, 36(8): 857-863.
[6]	ZHANG Wei, GUO Huijuan, WU Ximei, LING Xiuting, JIANG Xiaoxin, LIU Yunhong. Application value of serum sST2 level in monitoring rheumatoid arthritis and therapeutic effect [J]. Laboratory Medicine, 2021, 36(12): 1238-1242.
[7]	YAN Yufei, JIN Yiming, LIU Mingli, DENG Xuemei, QIN Qin. Role of neutrophil/lymphocyte ratio in SARS-CoV-2 infection [J]. Laboratory Medicine, 2020, 35(7): 637-639.
[8]	ZHOU Fujiang, WU Chengbin, GAO Shouxia, XU Chao, QIAN Wenying, HUANG Qiulan. Role of IDO/TTS ratio in the exclusion and disease assessment of RA [J]. Laboratory Medicine, 2020, 35(4): 304-309.
[9]	LIU Yixin, WEI Wei, WANG Yang, BAI Yingyu, WAN Chunyou, MA Jun, ZHENG Fang. TNF and CRT dual signaling for promoting NLRP3 inflammasome activation in synoviocytes for RA patients [J]. Laboratory Medicine, 2020, 35(4): 363-369.
[10]	CHEN Yabin, JIANG Yancheng, CHEN Zixuan, YANG Wei, ZHANG Zhishan. Diagnostic cut-off value of HbA₂ for screening thalassemia and the combined determination of HbA₂,MCV and MCH [J]. Laboratory Medicine, 2019, 34(4): 318-321.
[11]	WANG Xing, MA Yan, WANG Shengnan, ZHANG Heqian, LIU Rongzeng. Association of TIM-3 rs1036199 polymorphisms with the onset risk of rheumatoid arthritis：a Meta analysis [J]. Laboratory Medicine, 2019, 34(12): 1101-1106.
[12]	DONG Huijun, FAN Renzhi, ZHOU Hongyan, CHEN Xuemin, WU Yun, SHEN Zuojun. Internal imprecision status of routine chemical determination items in Anhui laboratories [J]. Laboratory Medicine, 2018, 33(8): 752-754.
[13]	XIE Wenge, LI Wen, HUANG Ning, LI Jinxing. Analytical quality requirement of range comparison for multiple biochemical analyzers in clinical laboratories [J]. Laboratory Medicine, 2018, 33(8): 760-763.
[14]	ZHANG Haichen, WANG Hao, SONG Yunxiao, MA Jin. Combined determination of multiple tumor markers for the diagnosis of primary lung cancer [J]. Laboratory Medicine, 2018, 33(7): 590-596.
[15]	LU Qiuya, LU Yide, SUN Aihua, MA Weiyun, ZHOU Yiqiong, WANG Xuefeng. Thromboelastography-MA parameter in the diagnosis of acute coronary syndrome [J]. Laboratory Medicine, 2018, 33(2): 119-123.