S.J. Naides, MD, Scientific Affairs, Euroimmun US, a PerkinElmer company, Mountain Lakes, New Jersey, and Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois;
J.R. Genzen, MD, PhD, Diagnostic Immunology and Flow Cytometry Committee, College of American Pathologists, Northfield, Illinois, and Pathology, University of Utah / ARUP Laboratories, Salt Lake City, Utah.
J Rheumatol. 2020 Dec 1;47(12):1768-1773. doi: 10.3899/jrheum.190933. Epub 2020 Mar 15.
This study was conducted to determine the spectrum of laboratory practices in antinuclear antibody (ANA) test target, performance, and result reporting.
A questionnaire on ANA testing was distributed by the Diagnostic Immunology and Flow Cytometry Committee of the College of American Pathologists (CAP) to laboratories participating in the 2016 CAP ANA proficiency survey.
Of 5847 survey kits distributed, 1206 (21%) responded. ANA screening method varied: 55% indirect immunofluorescence assay, 21% ELISA, 12% multibead immunoassay, and 18% other methods. The name of the test indicated the method used in only 32% of laboratories; only 39% stated the method used on the report. Of 644 laboratories, 80% used HEp-2 cell substrate, 18% HEp-2000 (HEp-2 cell line engineered to overexpress SSA antigen, Ro60), and 2% other. Slides were prepared manually (67%) or on an automated platform (33%) and examined by direct microscopy (84%) or images captured by an automated platform (16%). Only 50% reported a positive result at the customary 1:40 dilution. Titer was reported to endpoint routinely by 43%, only upon request by 23%, or never by 35%. Of the laboratories, 8% did not report dual patterns. Of those reporting multiple patterns, 23% did not report a titer with each pattern.
ANA methodology and practice, and test naming and reporting varies significantly between laboratories. Lack of uniformity in testing and reporting practice and lack of transparency in communicating the testing method may misdirect clinicians in their management of patients.
本研究旨在确定抗核抗体（ANA）检测靶标、性能和结果报告的实验室实践范围。
美国病理学家学院（CAP）的诊断免疫学和流式细胞术委员会向参与 2016 年 CAP ANA 能力验证调查的实验室分发了一份关于 ANA 检测的问卷。
在分发的 5847 份调查工具包中，有 1206 份（21%）做出了回应。ANA 筛选方法各不相同：55%间接免疫荧光法、21%ELISA、12%多珠免疫测定法和 18%其他方法。只有 32%的实验室在检测名称中指明了所使用的方法；只有 39%的实验室在报告中说明所使用的方法。在 644 家实验室中，80%使用 HEp-2 细胞底物，18%使用 HEp-2000（HEp-2 细胞系，经过基因工程改造以过度表达 SSA 抗原，Ro60），2%使用其他底物。载玻片是手动（67%）或在自动化平台上（33%）制备的，并用直接显微镜（84%）或自动化平台捕获的图像（16%）进行检查。只有 50%的实验室报告在常规 1:40 稀释度时的阳性结果。43%的实验室常规报告效价至终点，23%仅在需要时报告，35%的实验室则从不报告。8%的实验室不报告双模式。在报告多种模式的实验室中，23%的实验室没有报告每种模式的效价。
ANA 方法学和实践以及检测命名和报告在实验室之间存在显著差异。检测和报告实践缺乏一致性，以及在传达检测方法方面缺乏透明度，可能会导致临床医生在患者管理方面出现失误。
