Division of Rheumatology, Department of Internal Medicine, Istituto G Pini, University of Milan and IRCCS Istituto Auxologico Italiano, Milan, Italy.
Ann Rheum Dis. 2010 Aug;69(8):1420-2. doi: 10.1136/ard.2009.127100. Epub 2010 May 28.
The impact of autoimmune diseases is growing from both a clinical and a laboratory point of view. Diagnostic assays are now being transferred from dedicated specialised laboratories into high-throughput service laboratories. The increasing number of available methods has raised the variability among the laboratories, making their reproducibility a critical problem. On the other hand, reliable tests are needed for early diagnosis and prompt treatment, and the cost of repeated confirmatory tests should be reduced and unnecessary further investigations avoided. New methodologies, particularly for antinuclear antibodies (ANAs), have been applied to autoantibody detection in order to screen and process larger volumes of clinical specimens more quickly and at less cost than the traditional methods. However, because of the lack of their sensitivity to detect all ANAs and standardisation, inaccuracies (including false positives and negatives) in the results have been reported. A committee of the American College of Rheumatology was formed to address this issue. Specific recommendations have been suggested that represent a realistic first step in the standardisation of diagnostic tests for autoimmune diseases.
从临床和实验室角度来看，自身免疫性疾病的影响正在不断增加。诊断检测现在正从专门的专业实验室转移到高通量服务实验室。越来越多的方法的出现增加了实验室之间的可变性，使得它们的重现性成为一个关键问题。另一方面，需要可靠的检测方法进行早期诊断和及时治疗，并且应降低重复确认测试的成本，避免不必要的进一步检查。为了快速、低成本地筛选和处理更多数量的临床标本，已经将新的方法学，特别是针对抗核抗体（ANA）的方法学，应用于自身抗体检测中。然而，由于缺乏检测所有 ANA 的敏感性和标准化，结果存在不准确（包括假阳性和假阴性）的报道。美国风湿病学会成立了一个委员会来解决这个问题。已经提出了具体的建议，这代表了对自身免疫性疾病诊断测试标准化的现实的第一步。
