Serological Diagnostics of Lyme Borreliosis: Comparison of Universal and Borrelia Species-Specific Tests Based on Whole-Cell and Recombinant Antigens
Serological Diagnostics of Lyme Borreliosis: Comparison of Universal and Borrelia Species-Specific Tests Based on Whole-Cell and Recombinant Antigens
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DOI：
10.1128/jcm.00601-18
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发表时间：
2018-11-01
影响因子：
9.4
通讯作者：
Maly, Marek
中科院分区：
文献类型：
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作者：
Kodym, Petr;Kurzova, Zuzana;Maly, Marek
该研究比较了基于三种不同抗原类型的不同商业血清学试剂盒的诊断参数，并将检测结果与患者的疏螺旋体感染状态相关联。总共检测了8种IgM和8种IgG试剂盒，如下所示：基于全细胞抗原的酶联免疫吸附测定（ELISA）（Euroimmun）、3种属特异性酶免疫测定（EIA）（TestLine）、Liaison化学发光（DiaSorin）、ELISA-Viditest（Vidia）、EIA和使用重组抗原的Blot-Line（TestLine）。所有测试都是在一组90个样本上进行的，这些样本来自具有临床特征的疏螺旋体病患者（53个患有神经疏螺旋体病，32个患有游走性红斑，5个患有关节炎），加上70个来自献血者和梅毒患者的对照。基于全细胞抗原的ELISA具有上级灵敏度和上级阴性预测值，并且作为极好的筛选试验，尽管其特异性和阳性预测值较低。物种特异性测试的参数不稳定。它们的低敏感性和低阴性预测值阻碍了它们在常规诊断中的应用。重组抗原检测具有高特异性和高阳性预测值的特点，在诊断实践中具有广泛的用途。单个测试的诊断参数取决于样本组的组成。只有一小部分同时给出阴性和阳性结果的矛盾样本是导致检测结果差异的原因。检测结果与患者临床状态的相关性有限，尤其是在阴性和矛盾结果比例较高的游走性红斑组。相比之下，IgG测试结果在神经疏螺旋体病组，这是更一致的，显示可接受的协议与疏螺旋体状态。
The study compares diagnostic parameters of different commercial serological kits based on three different antigen types and correlates test results with the status of the patient's Borrelia infection. In total, 8 IgM and 8 IgG kits were tested, as follows: enzyme-linked immunosorbent assay (ELISA) (Euroimmun) based on whole-cell antigen, 3 species-specific enzyme immunoassays (EIAs) (TestLine), Liaison chemiluminescence (DiaSorin), ELISA-Viditest (Vidia), EIA, and Blot-Line (TestLine) using recombinant antigens. All tests were performed on a panel of 90 samples from patients with clinically characterized borreliosis (53 with neuroborreliosis, 32 with erythema migrans, and 5 with arthritis) plus 70 controls from blood donors and syphilis patients. ELISA based on whole-cell antigens has superior sensitivity and superior negative predictive value and serves as an excellent screening test, although its specificity and positive predictive values are low. Species-specific tests have volatile parameters. Their low sensitivity and low negative predictive value handicap them in routine diagnostics. Tests with recombinant antigens are characterized by high specificity and high positive predictive value and have a wide range of use in diagnostic practice. Diagnostic parameters of individual tests depend on the composition of the sample panel. Only a small proportion of contradictory samples giving both negative and positive results is responsible for discrepancies between test results. Correlation of test results with the patient's clinical state is limited, especially in the erythema migrans group with high proportions of negative and contradictory results. In contrast, IgG test results in the neuroborreliosis group, which are more concordant, show acceptable agreement with Borrelia status.