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所有抗瓜氨酸化蛋白/肽抗体检测的结果都相同吗?类风湿关节炎患者与非类风湿关节炎患者抗瓜氨酸化蛋白/肽抗体检测差异的评估。

Do all anti-citrullinated protein/peptide antibody tests measure the same? Evaluation of discrepancy between anti-citrullinated protein/peptide antibody tests in patients with and without rheumatoid arthritis.

作者信息

Vander Cruyssen B, Nogueira L, Van Praet J, Deforce D, Elewaut D, Serre G, De Keyser F

机构信息

Department of Rheumatology, Ghent University Hospital, B-9000 Gent, Belgium.

出版信息

Ann Rheum Dis. 2008 Apr;67(4):542-6. doi: 10.1136/ard.2007.071654. Epub 2007 Jul 20.

Abstract

BACKGROUND

Different methods exist to demonstrate anti-citrullinated protein/peptide antibodies (ACPA).

AIMS

To evaluate discrepancy between four ACPA tests.

PATIENTS AND METHODS

Population 1 consisted of patients with a new diagnostic problem, including 86 patients with rheumatoid arthritis (RA) and 450 patients without RA. Population 2 consisted of 155 patients with RA who had long-standing disease. Population 3 consisted of 188 patients with psoriatic arthritis and in population 4 there were 192 patients with systemic lupus erythematosus. Populations 1 and 2 were tested with the anti-human fibrinogen antibody (AhfibA) test, anti-CCP2 from Eurodiagnostica (CCP2-euro), anti-CCP2 from Pharmacia (CCP2-phar) and anti-CCP3 test by Inova (CCP3). Samples were annotated as discrepant if positive in one and negative in at least one other test. Each discrepant sample was re-analysed in a different run. Populations 3 and 4 were analysed in the CCP2-euro and AhFibA test.

RESULTS

In population 1, ACPA positivity was found in 17 of 450 (3.8%) patients without RA; 14 (82%) of these 17 samples were discrepant. In contrast, 61 of 86 (70.9%) patients with RA were ACPA positive of whom 18 of 61 (29.5%) were discrepant (70.9% vs. 29.5%, p<0.001). The discrepancies between tests could be partly attributed to borderline results, inter-assay discrepancy and inter-test variability. They were more prevalent in patients with systemic lupus erythematosus who were ACPA positive than in those with psoriatic arthritis who were ACPA positive.

CONCLUSIONS

Discrepancy between different ACPA tests was observed attributable to the occurrence of borderline results, inter-assay variability and mainly to inter-test variability. The lowest inter-test discrepancy is observed between tests that use the same substrate.

摘要

背景

存在多种方法可用于检测抗瓜氨酸化蛋白/肽抗体(ACPA)。

目的

评估四种ACPA检测方法之间的差异。

患者与方法

群体1由有新诊断问题的患者组成,包括86例类风湿关节炎(RA)患者和450例非RA患者。群体2由155例患有长期疾病的RA患者组成。群体3由188例银屑病关节炎患者组成,群体4有192例系统性红斑狼疮患者。群体1和群体2接受了抗人纤维蛋白原抗体(AhfibA)检测、欧洲诊断公司的抗CCP2(CCP2-euro)检测、法玛西亚公司的抗CCP2(CCP2-phar)检测以及Inova公司的抗CCP3检测(CCP3)。如果一个样本在一种检测中呈阳性而在至少一种其他检测中呈阴性,则将该样本标注为有差异。每个有差异的样本在不同批次中重新分析。群体3和群体4接受了CCP2-euro检测和AhFibA检测。

结果

在群体1中,450例非RA患者中有17例(3.8%)ACPA呈阳性;这17个样本中有14个(82%)有差异。相比之下,86例RA患者中有61例(70.9%)ACPA呈阳性,其中61例中的18例(29.5%)有差异(70.9%对29.5%,p<0.001)。检测之间的差异部分可归因于临界结果、批间差异和检测间变异性。它们在ACPA呈阳性的系统性红斑狼疮患者中比在ACPA呈阳性的银屑病关节炎患者中更普遍。

结论

观察到不同ACPA检测方法之间存在差异,这归因于临界结果的出现、批间变异性,主要是检测间变异性。使用相同底物的检测之间观察到的检测间差异最低。

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