HOB检测系统与Abbott检测系统测定抗环瓜氨酸肽抗体的一致性
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摘要
目的比较两种检测系统测定抗环瓜氨酸肽(CCP)抗体的一致性,为临床选择抗CCP抗体检测方法提供依据。方法依据定量测量方法的精密度性能评价(EP5-A2)、定量测量方法的线性评价(EP6-A)标准分别对苏州浩欧博(HOB)检测系统测定抗CCP抗体进行重复性和稀释线性验证;同时收集45例类风湿性关节炎(RA)患者、21例非RA自身免疫性疾病患者和24例健康体检者血清;分别采用HOB与美国雅培(Abbott)检测系统对血清抗CCP抗体进行检测,并对结果进行一致性分析。结果 HOB检测系统测定抗CCP抗体的重复性、稀释线性的性能验证合格;HOB检测系统与Abbott检测系统检测显示,RA组、非RA自身免疫性疾病组和正常对照组三组血清抗CCP抗体水平比较差异有统计学意义(P<0.001);HOB检测系统测定RA患者血清抗CCP抗体阳性率为88.9%,与Abbott检测系统(95.6%)比较,差异无统计学意义(P>0.05);HOB检测系统与Abbott检测系统测定抗CCP抗体具有一致性(P<0.001),其Kappa=0.933。结论 HOB检测系统与Abbott检测系统测定抗CCP抗体具有较高的一致性。
Objective To evaluate the consistency of 2 systems for the determination of anti-cyclic citrullinated peptide(anti-CCP), and provide a reference for choosing methods for anti-cyclic citrullinated peptide determination. Methods The performance of the repeatability and linear test for the determination of anti-CCP in HOB were evaluated respectively according to EP5-A2 and EP6-A. The serum samples of 45 patients with rheumatoid arthritis(RA), 21 patients with other autoimmune diseases and 24 healthy controls were collected. The serum level of anti-CCP was determined by 2 systems respectively,HOB and Abbott detection system; and the consistency of the results was analyzed. Results The evaluation of repeatability and linear test for the determination of anti-CCP in HOB were qualified. The results by HOB and Abbott showed that there were significant differences in serum anti-CCP levels among RA group, non-RA autoimmune disease group and normal control group(P<0.001). The positive rates of anti-CCP were 88.9% by HOB and 95.6% by Abbott in RA patients; there was no significant difference between HOB and Abbott detection system(P>0.05). The results of HOB and Abbott detection system were consistent in the determination of anti-CCP(P<0.001), and the Kappa was 0.933.Conclusion The consistency of HOB and Abbott detection system in determining anti-CCP was high.
Objective To evaluate the consistency of 2 systems for the determination of anti-cyclic citrullinated peptide(anti-CCP), and provide a reference for choosing methods for anti-cyclic citrullinated peptide determination. Methods The performance of the repeatability and linear test for the determination of anti-CCP in HOB were evaluated respectively according to EP5-A2 and EP6-A. The serum samples of 45 patients with rheumatoid arthritis(RA), 21 patients with other autoimmune diseases and 24 healthy controls were collected. The serum level of anti-CCP was determined by 2 systems respectively,HOB and Abbott detection system; and the consistency of the results was analyzed. Results The evaluation of repeatability and linear test for the determination of anti-CCP in HOB were qualified. The results by HOB and Abbott showed that there were significant differences in serum anti-CCP levels among RA group, non-RA autoimmune disease group and normal control group(P<0.001). The positive rates of anti-CCP were 88.9% by HOB and 95.6% by Abbott in RA patients; there was no significant difference between HOB and Abbott detection system(P>0.05). The results of HOB and Abbott detection system were consistent in the determination of anti-CCP(P<0.001), and the Kappa was 0.933.Conclusion The consistency of HOB and Abbott detection system in determining anti-CCP was high.
引文
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[13]杨梅花,王向红,冯忠军,等.RA患者血清中RF、CCP抗体、GPI抗原以及AKA检测的临床意义[J].热带医学杂志,2016,16(3):346-348.
[14]Chon H,Lee S,Wang R,et al.SERS-based immunoassay of anti-cyclic citrullinated peptide for early diagnosis of rheumatoid arthritis[J].RSC Adv,2014,4(62):32924-32927.
[15]张静思,陈鑫萍,陈斌.RF、抗-CCP、AKA及GPI联合检测在类风湿关节炎诊断中的价值[J].重庆医学,2015,44(13):1788-1793.
[16]Porto LS,Tavares WC Júnior,Costa DA,et al.Anti-CCPantibodies are not a marker of severity in established rheumatoid arthritis:a magnetic resonance imaging study[J].Rev Bras Reumatol Engl Ed,2017,57(1):15-22.
[2]Uutela TI,Kautiainen HJ,Hakkinen AH.Decreasing muscle performance associated with increasing disease activity in patients with rheumatoid arthritis[J].PLoS One,2018,13(4):e0194917.
[3]Aletaha D,Neoai T,Sihnan AT,et al.2010 Rheumatoid arthritis classification criteria:an American College of Rheumatoloay/European League Against Rheumatism collaborative initative[J].Arthritis Rheum,2010,62(9):2569-2581.
[4]夏冒李,李娟,吴婧,等.类风湿关节炎2010ACR/EULAR与1987ACR诊断分类标准的诊断效能比较研究[J].热带医学杂志,2013,13(5):606-610.
[5]付琳,裘宇容.抗环瓜氨酸肽抗体检测方法的研究进展[J].广东医学,2012,33(12):1850-1853.
[6]杜满兴,王伟佳,黄秋虹.2种检测方法在类风湿关节炎抗环瓜氨酸肽抗体检测中临床价值比较[J].国际检验医学杂志,2015,36(11):1523-1524,1527.
[7]王梦露,王云龙,石晓卫,等.抗环瓜氨酸肽抗体胶体金定量检测方法的建立[J].中国现代医学杂志,2016,26(12):25-29.
[8]Fu L,Kang CM,Zhang P,et al.A modified quick PETIA for detecting anti-CCP antibodies in human serum[J].Anal Methods,2015,7(7):3134-3140.
[9]CLSI.EP5-A2 Evaluation of precision performance of quantitative measurement methods;approved guideline[S].2004.
[10]NCCLS.EP6-A Evaluation of the linearity of quantitative analytical methods:a statistical approach,approved guideline[S].2003.
[11]叶霖,王友莲.类风湿关节炎的中西医发病机制综述[J].江西医药,2017,52(1):88-91.
[12]Harnden K,Pease C,Jackson A.Rheumatoid arthritis[J].BMJ,2016,352:i387.
[13]杨梅花,王向红,冯忠军,等.RA患者血清中RF、CCP抗体、GPI抗原以及AKA检测的临床意义[J].热带医学杂志,2016,16(3):346-348.
[14]Chon H,Lee S,Wang R,et al.SERS-based immunoassay of anti-cyclic citrullinated peptide for early diagnosis of rheumatoid arthritis[J].RSC Adv,2014,4(62):32924-32927.
[15]张静思,陈鑫萍,陈斌.RF、抗-CCP、AKA及GPI联合检测在类风湿关节炎诊断中的价值[J].重庆医学,2015,44(13):1788-1793.
[16]Porto LS,Tavares WC Júnior,Costa DA,et al.Anti-CCPantibodies are not a marker of severity in established rheumatoid arthritis:a magnetic resonance imaging study[J].Rev Bras Reumatol Engl Ed,2017,57(1):15-22.