Uto Kenichi, Hayashi Nobuhide, Kinoshita Shouhiro, Kawano Seiji, Kumagai Shunichi
Clinical Pathology and Immunology, Kobe University Graduate School of Medicine, Kobe 650-0017, Japan.
Rinsho Byori. 2009 Oct;57(10):941-53.
BioPlex2200 is a fully automated analyzer using multiplexed technology and BioPlex2200 ANA Screen can analyze 11 antinuclear antibodies (ANA). We evaluated simultaneous detection of 11 ANA and clinical utility as ANA screening test. We collected sera from 317 connective tissue disease (CTD) patients, 166 healthy subjects, and 105 sera in which anti dsDNA antibody(RIA) is requested. Detection of 11 ANA were measured by BioPlex2200 ANA Screen using BioPlex2200 along with conventional methods. We evaluated positive ratio for healthy subjects and CTD patients and concordance rate between BioPlex2200 and IF. The prevalence of disease specific ANA in CTD patients were comparable with general occurrence rate except anti dsDNA antibody (39.3%) in SLE. Concordance rate between BioPlex2200 and conventional methods were high(89.0-99.7%) except anti dsDNA antibody(ELISA: 68.8%, RIA: 58.1%). Discordant sera of Bioplex2200+/DID- for anti SS-A antibodies were observed in 30 sera, and 20 sera were positive only for anti 52kD SS-A/Ro antibody. As ANA screening test, positive ratio was low (7.2%) in healthy subjects, and comparable with that of IF(1:160). Concordance rate between BioPlex2200 and IF was low (75.1%). However, 44 sera of BioPlex2200+/IF- contained 6 samples positive for anti Jo-1 antibodies and 29 samples positive for anti-52kD SS-A/Ro antibodies. Diagnostic accuracy of the Medical Decision Support Software (MDSS) by BioPlex2200 as compared to clinical diagnosis is good for specificity. Taken together, BioPlex2200 can appropriately perform simultaneous detection of 11 ANA and detect independently anti-52kD SS-A/Ro antibody. However, detection for anti dsDNA antibody of low titers is needed to be improved.
BioPlex2200是一款采用多重技术的全自动分析仪，BioPlex2200抗核抗体（ANA）筛查检测板可分析11种抗核抗体。我们评估了11种抗核抗体的同时检测情况以及作为ANA筛查试验的临床应用价值。我们收集了317例结缔组织病（CTD）患者、166例健康受试者的血清以及105例要求检测抗双链DNA抗体（RIA法）的血清。使用BioPlex2200通过BioPlex2200 ANA筛查检测板检测11种抗核抗体，并同时采用传统方法进行检测。我们评估了健康受试者和CTD患者的阳性率以及BioPlex2200与间接免疫荧光法（IF）之间的符合率。CTD患者中疾病特异性抗核抗体的患病率与总体发生率相当，但系统性红斑狼疮（SLE）中抗双链DNA抗体的患病率为39.3%。除抗双链DNA抗体外（酶联免疫吸附测定法（ELISA）：68.8%，放射免疫测定法（RIA）：58.1%），BioPlex2200与传统方法之间的符合率较高（89.0 - 99.7%）。在30份血清中观察到BioPlex2200检测抗SS - A抗体呈阳性/免疫扩散法（DID）呈阴性的不一致血清，其中20份血清仅抗52kD SS - A/Ro抗体呈阳性。作为ANA筛查试验，健康受试者的阳性率较低（7.2%），与间接免疫荧光法（1:160）相当。BioPlex2200与间接免疫荧光法之间的符合率较低（75.1%）。然而，BioPlex2200检测呈阳性/间接免疫荧光法检测呈阴性的44份血清中，有6份抗Jo - 1抗体呈阳性，29份抗52kD SS - A/Ro抗体呈阳性。与临床诊断相比，BioPlex2200的医学决策支持软件（MDSS）的诊断准确性在特异性方面表现良好。综上所述，BioPlex2200能够适当地同时检测11种抗核抗体，并能独立检测抗52kD SS - A/Ro抗体。然而，低滴度抗双链DNA抗体的检测仍需改进。
