Azienda Ospedaliero-Universitaria Parma, Via Gramsci 14, Parma, Italy.
Autoimmun Rev. 2011 Nov;11(1):1-5. doi: 10.1016/j.autrev.2011.06.006. Epub 2011 Jun 28.
The presence of specific auto-antibodies in serum (i.e., antinuclear antibodies or ANA, anti-extractable nuclear antigens or anti-ENA, and anti-double stranded DNA or anti-dsDNA ) is one of the major criteria in the diagnostics of Autoimmune Rheumatic Disease. As such, the request for these tests has grown exponentially in laboratory practice. The aim of this study is to describe the implementation of a joint laboratory-clinics guideline for reducing clinically inappropriate requests for autoantibody testing in a broad geographic area (Parma, Modena, Piacenza, Reggio-Emilia) for the diagnosis of Autoimmune Rheumatic Disease.
This study, supported by a Regional grant for innovative research projects started in January 2008, is an observational research aimed at comparing the number of ANA, anti-dsDNA and anti-ENA testing as well as the percentage of positive test results before and after implementation of the diagnostic algorithm in hospitalized patients. A multidisciplinary team consisting of clinical immunologist and laboratory scientists was established, with the aim of collecting and analysing diagnostic criteria, clinical needs, laboratory report formats, analytical procedures, as well as the number of tests performed. The laboratory results and the clinical protocol were both validated by data emerging from the clinical follow-up studies.
A joint guideline for auto-antibody testing, placing ANA test at the first level, has been developed and implemented since January 2009. The results for the period January-June 2009 (12,738 tests) were compared with those of the same period in 2008 (13,067 tests). A significant reduction in the number of anti-dsDNA (-26%) and anti-ENA (-15%) was observed. The percentage of second-level tests positivity after implementation of the diagnostic protocol had also consistently increased for both ENA (13% vs 17%) and dsDNA (9% vs 11%).
The development and implementation of algorithms for the diagnostics of Autoimmune Rheumatic Disease in hospitalized patients was associated with a reduction in the number of second-level tests, but also with an increased diagnostic specificity. This outcome attests that close collaboration and audit between clinicians, laboratory specialists and healthcare services is effective to develop efficient diagnostic algorithms for both hospitalized patients and outpatients.
血清中特定自身抗体的存在（即抗核抗体或 ANA、抗可提取核抗原或抗 ENA、抗双链 DNA 或抗 dsDNA）是自身免疫性风湿病诊断的主要标准之一。因此，这些检测的需求在实验室实践中呈指数级增长。本研究旨在描述在广泛的地理区域（帕尔马、摩德纳、皮亚琴扎、艾米利亚-罗马涅）实施联合实验室-临床指南，以减少自身抗体检测在诊断自身免疫性风湿病方面的临床不适当请求。
本研究由一项针对创新研究项目的区域拨款支持，于 2008 年 1 月开始，是一项观察性研究，旨在比较实施诊断算法前后住院患者的 ANA、抗 dsDNA 和抗 ENA 检测数量以及阳性检测结果的百分比。成立了一个由临床免疫学家和实验室科学家组成的多学科团队，旨在收集和分析诊断标准、临床需求、实验室报告格式、分析程序以及进行的检测数量。实验室结果和临床方案均通过临床随访研究的数据进行验证。
自 2009 年 1 月以来，已经制定并实施了一份自身抗体检测联合指南，将 ANA 检测置于第一级。比较了 2009 年 1 月至 6 月（12738 次检测）与 2008 年同期（13067 次检测）的结果。抗 dsDNA（-26%）和抗 ENA（-15%）的检测数量显著减少。实施诊断方案后，ENA（13%比 17%）和 dsDNA（9%比 11%）的二级检测阳性率也持续增加。
在住院患者中诊断自身免疫性风湿病的算法的开发和实施与二级检测数量的减少有关，但也与诊断特异性的提高有关。这一结果证明，临床医生、实验室专家和医疗保健服务之间的密切合作和审核可以有效地为住院患者和门诊患者开发有效的诊断算法。
