Gniewek R A, Stites D P, McHugh T M, Hilton J F, Nakagawa M
Bio-Rad Laboratories, Hercules, California 94547, USA.
Clin Diagn Lab Immunol. 1997 Mar;4(2):185-8. doi: 10.1128/cdli.4.2.185-188.1997.
Performances of anti-nuclear antibody testing by immunofluorescence assay (ANA-IFA) and enzyme immunoassay (ANA-EIA) were compared in relation to patient diagnosis. A total of 467 patient serum samples were tested by ANA-IFA (Kallestad; Sanofi) and ANA-EIA (RADIAS; Bio-Rad), and their age, sex, diagnosis, disease status, and medications were obtained through chart review. Reference ranges were established by testing 98 healthy blood donor samples. Eighty-six samples came from patients with diffuse connective tissue diseases, including systemic lupus erythematosus, discoid lupus erythematosus, or drug-induced lupus (n = 71); systemic sclerosis, CREST syndrome (calcinosis, Raynaud's phenomenon, esophageal motility abnormalities, sclerodactyly, and telangiectasia), or Raynaud's syndrome (n = 8); Sjögren's syndrome (n = 5); mixed connective tissue disease (n = 5); and polymyositis or dermatomyositis (n = 3). The sensitivity, specificity, positive predictive value, and negative predictive value for ANA-IFA were 87.2, 48.0, 29.1, and 93.9%, respectively, for the reference range of < 1:160. For ANA-EIA, they were 90.7, 60.2, 35.8, and 96.4%, respectively, for the reference range of < 0.9. ANA-EIA offers equivalent sensitivity and higher specificity compared to ANA-IFA.
比较了免疫荧光法（ANA-IFA）和酶免疫法（ANA-EIA）检测抗核抗体在患者诊断方面的性能。共对467份患者血清样本进行了ANA-IFA（Kallestad；赛诺菲）和ANA-EIA（RADIAS；伯乐）检测，并通过查阅病历获取了患者的年龄、性别、诊断、疾病状态和用药情况。通过检测98份健康献血者样本建立了参考范围。86份样本来自弥漫性结缔组织病患者，包括系统性红斑狼疮、盘状红斑狼疮或药物性狼疮（n = 71）；系统性硬化症、CREST综合征（钙质沉着、雷诺现象、食管动力异常、指端硬化和毛细血管扩张）或雷诺综合征（n = 8）；干燥综合征（n = 5）；混合性结缔组织病（n = 5）；以及多发性肌炎或皮肌炎（n = 3）。对于ANA-IFA，当参考范围<1:160时，敏感性、特异性、阳性预测值和阴性预测值分别为87.2%、48.0%、29.1%和93.9%。对于ANA-EIA，当参考范围<0.9时，它们分别为90.7%、60.2%、35.8%和96.4%。与ANA-IFA相比，ANA-EIA具有相当的敏感性和更高的特异性。
