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Measurement of Antinuclear Antibodies: Assessment of Different Test Systems

机译：抗核抗体的测量：不同测试系统的评估

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The performance of rat liver and HEp-2 in the detection of antinuclear antibodies (ANA) was studied by two independent sites and compared against an ANA enzyme immunoassay (EIA) screen and EIA systems for the measurement of antibodies to double-stranded DNA (dsDNA) and ENA. Sixty-two sera from patients with connective tissue disease (CTD) and 398 from controls suffering from other disorders were included. The level of agreement was, for HEp-2 and rat liver (within one site), 82.0% (ANA positive/ANA negative) and 51.0% (ANA pattern); and for HEp2- and HEp-2 (between sites), 71.8 and 86.5%. On sera with the ANA homogeneous pattern, the measurement of anti-ENA EIA added little to the detection rate with anti-dsDNA EIA alone. On ANA speckled sera, the EIA reactivity depended on the reaction of the mitotic cells: while sera with positive mitoses reacted similarly to ANA homogeneous sera, in those with negative mitoses the measurement of anti-ENA added about 10% to the detection rate achieved with anti-dsDNA alone. The measurement of anti-Scl-70 and anti-Jo-1 did not markedly improve the positive rate with classical ENA (anti-SSA, -SSB, -Sm, and -RNP) alone, raising doubts about the cost efficiency of including these measurements in unselected sera. The ANA EIA identified patients with CTD at a rate similar to that for rat liver and HEp-2. However, up to 98% of the sera found to be negative by ANA EIA but positive by use of rat liver and HEp-2 were from controls. Thus, the ANA EIA may possible be used as an alternative screen, particularly in laboratories with a high frequency of sera from patients not suffering from CTD.
机译：通过两个独立的站点研究了大鼠肝脏和HEp-2在检测抗核抗体（ANA）中的性能，并与ANA酶免疫分析（EIA）筛查和EIA系统进行了比较，以测量双链DNA（dsDNA）抗体）和ENA。包括来自结缔组织病（CTD）患者的62份血清和患有其他疾病的对照组的398份血清。对于HEp-2和大鼠肝脏（一个部位内），一致水平为82.0％（ANA阳性/ ANA阴性）和51.0％（ANA模式）；而对于HEp2-和HEp-2（在位点之间），分别为71.8和86.5％。在具有ANA均质模式的血清中，仅使用抗dsDNA EIA进行抗ENA EIA的检测几乎不会增加检测率。在ANA斑点的血清上，EIA反应性取决于有丝分裂细胞的反应：虽然具有阳性有丝分裂的血清与ANA均质血清的反应相似，但是对于具有阴性有丝分裂的血清，抗ENA的测量将通过单独使用抗dsDNA。单独使用经典ENA（anti-SSA，-SSB，-Sm和-RNP）进行抗Scl-70和抗Jo-1的检测并不能显着提高阳性率，这令人怀疑是否包含这些化合物在未选择的血清中进行测量。 ANA EIA以与大鼠肝脏和HEp-2相似的比率鉴定出CTD患者。然而，高达98％的血清被ANA EIA鉴定为阴性，而使用大鼠肝脏和HEp-2则为阳性。因此，ANA EIA可能可以用作替代筛选，尤其是在来自未患有CTD的患者中血清频率较高的实验室中。

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