Van Hoovels Lieve, Studholme Lucy, Vander Cruyssen Bert, Sieghart Daniela, Bonroy Carolien, Nagy Eszter, Pullerits Rille, Čučnik Sasa, Dahle Charlotte, Heijnen Ingmar, Bernasconi Luca, Benkhadra Farid, Bogaert Laura, Van Den Bremt Stefanie, Van Liedekerke Ann, Vanheule Geert, Robbrecht Johan, Wirth Claudine, Müller Rüdiger, Kyburz Diego, Sjöwall Christopher, Kastbom Alf, Ješe Rok, Jovancevic Boja, Kiss Emese, Jacques Peggy, Aletaha Daniel, Steiner Günter, Verschueren Patrick, Bossuyt Xavier
Department of Microbiology, Immunology and Transplantation, KU Leuven, Leuven, Belgium
Department of Laboratory Medicine, Onze-Lieve-Vrouwziekenhuis Aalst, Aalst, Belgium.
Ann Rheum Dis. 2022 Sep 12;81(10):1379-1384. doi: 10.1136/annrheumdis-2021-221849.
Commercial assays measuring antibodies to citrullinated protein/peptide (ACPA) show poor quantitative agreement. The diagnostic industry has never adopted the International Union of Immunological Societies-Centers for Disease Control and Prevention (IUIS-CDC) ACPA reference standard. Recently, the National Institute for Biological Standards and Control (NIBSC) prepared a new candidate ACPA standard (18/204). We evaluated both reference materials using different commercially available ACPA assays.
This is an international study in which the NIBSC candidate ACPA standard and the IUIS-CDC ACPA reference material were analysed together with 398 diagnostic samples from individuals with rheumatoid arthritis (RA) and in 1073 individuals who did not have RA using nine commercial ACPA assays.
For both reference materials and samples from individuals with RA and individuals who did not have RA, there were large differences in quantitative ACPA results between assays. For most assays, values for the IUIS-CDC standard were lower than values for NIBSC 18/204 and the IUIS-CDC/NIBSC ratio was comparable for several, but not all assays. When NIBSC 18/204 was used as a calibrator, an improvement in alignment of ACPA results across several of the evaluated assays was obtained. Moreover, NIBSC 18/204 could align clinical interpretation for some but not all assays.
Adoption of an international standard for ACPA determination is highly desirable. The candidate NIBSC 18/204 standard improved the standardisation and alignment of most ACPA assays and might therefore be recommended to be used as reference in commercial assays.
用于检测瓜氨酸化蛋白/肽抗体（ACPA）的商业检测方法在定量方面一致性较差。诊断行业从未采用过国际免疫学会 - 疾病控制与预防中心（IUIS - CDC）的ACPA参考标准。最近，国家生物标准与控制研究所（NIBSC）制备了一种新的ACPA候选标准品（18/204）。我们使用不同的市售ACPA检测方法对这两种参考物质进行了评估。
这是一项国际研究，其中NIBSC的ACPA候选标准品和IUIS - CDC的ACPA参考物质与来自类风湿关节炎（RA）患者的398份诊断样本以及1073名非RA患者的样本一起，使用九种商业ACPA检测方法进行了分析。
对于参考物质以及RA患者和非RA患者的样本，各检测方法之间的ACPA定量结果存在很大差异。对于大多数检测方法，IUIS - CDC标准品的值低于NIBSC 18/204的值，并且IUIS - CDC/NIBSC比率在几种（但不是所有）检测方法中具有可比性。当将NIBSC 18/204用作校准物时，在几种评估的检测方法中ACPA结果的一致性得到了改善。此外，NIBSC 18/204可以使部分（但不是全部）检测方法的临床解释趋于一致。
非常有必要采用ACPA测定的国际标准。候选的NIBSC 18/204标准改善了大多数ACPA检测方法的标准化和一致性，因此可能推荐将其用作商业检测的参考标准。
