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三种酶联免疫吸附测定法检测抗环瓜氨酸肽抗体在类风湿关节炎早期诊断中的效能

Efficacy of three ELISA measurements of anti-cyclic citrullinated peptide antibodies in the early diagnosis of rheumatoid arthritis.

作者信息

Fernández-Suárez Antonio, Reneses Sonsoles, Wichmann Ingeborg, Criado Rita, Núñez Antonio

机构信息

Department of Biotechnology, Empresa Pública Hospital de Poniente de Almería, El Ejido, Almería, Spain.

出版信息

Clin Chem Lab Med. 2005;43(11):1234-9. doi: 10.1515/CCLM.2005.214.

Abstract

The objective of the present study was to determine the efficacy of anti-cyclic citrullinated peptide (anti-CCP) antibody detection in the early diagnosis of rheumatoid arthritis (RA), as well as to compare three commercially available enzyme-linked immunosorbent assay (ELISA) kits used to detect such antibodies. We analysed the presence of anti-CCP antibodies in the sera of 78 patients who had been newly referred from primary healthcare centres to the Early Polyarthritis Unit. We also included in the study a group of 50 healthy controls. None of the patients had previously received treatment for the disease. After 1-year follow-up, the diagnosis of RA was confirmed in 53 of these patients. The ELISA kits under study were IMMUNOSCAN RA (Euro-Diagnostica AB), QUANTA Lite CCP IgG ELISA (INOVA Diagnostic) and DIA-STAT Anti-CCP (Axis-Shield Diagnostics); the sensitivity obtained was 52.8%, 58.5% and 52.8%, respectively, with 100% specificity for all three kits. Anti-CCP antibodies detected the presence of RA in 26% of patients without positive rheumatoid factor (RF). The sum of anti-CCP antibodies or the presence of RF gave a sensitivity of up to 67%, with specificity ranging between 94 and 97%. Anti-CCP antibodies show high specificity for the diagnosis of RA. The three ELISAs analysed offer the same degree of diagnostic accuracy.

摘要

本研究的目的是确定抗环瓜氨酸肽(抗CCP)抗体检测在类风湿关节炎(RA)早期诊断中的有效性,并比较三种用于检测此类抗体的市售酶联免疫吸附测定(ELISA)试剂盒。我们分析了78例从初级医疗保健中心新转诊至早期多关节炎科的患者血清中抗CCP抗体的存在情况。我们还在研究中纳入了一组50名健康对照。这些患者此前均未接受过该疾病的治疗。经过1年的随访,其中53例患者被确诊为RA。所研究的ELISA试剂盒分别为IMMUNOSCAN RA(欧洲诊断公司)、QUANTA Lite CCP IgG ELISA(英诺华诊断公司)和DIA-STAT抗CCP(阿克斯-希尔德诊断公司);获得的灵敏度分别为52.8%、58.5%和52.8%,三种试剂盒的特异性均为100%。抗CCP抗体在26%类风湿因子(RF)阴性的患者中检测到RA的存在。抗CCP抗体与RF同时存在时,灵敏度高达67%,特异性在94%至97%之间。抗CCP抗体对RA的诊断具有高度特异性。所分析的三种ELISA试剂盒具有相同程度的诊断准确性。

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