Bizzaro N, Tozzoli R, Tonutti E, Piazza A, Manoni F, Ghirardello A, Bassetti D, Villalta D, Pradella M, Rizzotti P
Laboratorio di Patologia Clinica, Ospedale Civile, S. Donà di Piave (VE), Italy.
J Immunol Methods. 1998 Oct 1;219(1-2):99-107. doi: 10.1016/s0022-1759(98)00140-9.
This study was performed by the Italian Society of Laboratory Medicine (SIMeL) in order to establish the variability between the different analytical systems currently used in clinical laboratories for the detection of autoantibodies diagnostic of systemic autoimmune disease. Sixteen industrial, and two university laboratories participated in this study which entailed the determination of anti-nuclear (ANA), anti-dsDNA and anti-ENA antibodies in 11 sera from patients with clinically diagnosed systemic rheumatic disease, using reagents produced by these companies and different methodologies (indirect immunofluorescence, immunoenzymatic assay, counterimmunolectrophoresis, immuno and western blotting). We found 93.5% agreement between the methods used for the detection of ANA, 85.2% for anti-dsDNA antibodies, and 86.9% for anti-ENA antibodies. Among the anti-ENA antibodies, regardless of the method used, detection percentages were excellent for anti-RNP and anti-SSB/La (100%), good for anti-SSA/Ro (93%), but unacceptable for the anti-Jo-1 (67%), anti-Scl70 and anti-Sm (47%) antibodies. This further stresses the need for rigorous standardisation of commercial reagents and analytical procedures, as well as the introduction of external quality assessment (EQA) programs, and a complete definition of operative protocols adjusted to the sensitivity and specificity of the various methods.
这项研究由意大利实验医学协会（SIMeL）开展，旨在确定临床实验室目前用于检测系统性自身免疫性疾病诊断性自身抗体的不同分析系统之间的差异。16家工业实验室和2家大学实验室参与了这项研究，该研究要求使用这些公司生产的试剂和不同方法（间接免疫荧光法、免疫酶测定法、对流免疫电泳法、免疫印迹法和蛋白质印迹法），对11例临床诊断为系统性风湿性疾病患者的血清中的抗核抗体（ANA）、抗双链DNA抗体和抗可提取性核抗原（ENA）抗体进行测定。我们发现，检测ANA的方法之间一致性为93.5%，抗双链DNA抗体为85.2%，抗ENA抗体为86.9%。在抗ENA抗体中，无论使用何种方法，抗核糖核蛋白（RNP）抗体和抗SSB/La抗体的检测率极佳（100%），抗SSA/Ro抗体良好（93%），但抗Jo-1抗体（67%）、抗Scl70抗体和抗Sm抗体（47%）的检测率不可接受。这进一步强调了商业试剂和分析程序严格标准化的必要性，以及引入外部质量评估（EQA）计划，以及根据各种方法的敏感性和特异性对操作方案进行完整定义的必要性。
