Commercial cellular tests are used to diagnose Lyme borreliosis (LB), but studies on their clinical validation are lacking. This study evaluated the utility of an in-house and a commercial enzyme-linked immunosorbent spot (ELISpot) assay for the diagnosis of Lyme neuroborreliosis (LNB). Prospectively, peripheral blood mononuclear cells (PBMCs) were isolated from patients and controls and analysed using an in-house Borrelia ELISpot assay and the commercial LymeSpot assay. B. burgdorferi B31 whole cell lysate and a mixture of outer surface proteins were used to stimulate the PBMCs and the numbers of interferon-gamma-secreting T cells were measured. Results were evaluated using receiver operating characteristic (ROC) curve analysis. Eighteen active and 12 treated LNB patients, 10 healthy individuals treated for an early (mostly cutaneous) manifestation of LB in the past and 47 untreated healthy individuals were included. Both assays showed a poor diagnostic performance with sensitivities, specificities, positive and negative predictive values ranging from 44.4-66.7%, 42.0-72.5%, 21.8-33.3% and 80.5-87.0%, respectively. The LymeSpot assay performed equally poorly when the calculation method of the manufacturer was used. Both the in-house and the LymeSpot assay are unable to diagnose active LNB or to monitor antibiotic treatment success.

中文翻译：

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两种酶联免疫吸附点测定法对莱姆病神经疏螺旋体的诊断的前瞻性比较。

商业细胞测试用于诊断莱姆病（LB），但缺乏有关临床验证的研究。这项研究评估了内部和商业酶联免疫吸附斑点（ELISpot）测定法在诊断莱姆病（LNB）中的实用性。预期地，从患者和对照中分离出外周血单核细胞（PBMC），并使用内部的Borrelia ELISpot测定法和商业LymeSpot测定法进行分析。B. burgdorferi B31全细胞裂解液和外表面蛋白混合物用于刺激PBMC，并测量了干扰素-γ分泌T细胞的数量。使用接收器工作特性（ROC）曲线分析评估结果。18位活跃的LNB患者和12位接受治疗的患者，过去曾接受过LB早期（主要是皮肤）治疗的10位健康个体和47位未经治疗的健康个体被纳入研究。两种测定均显示出较差的诊断性能，其敏感性，特异性，阳性和阴性预测值分别为44.4-66.7％，42.0-72.5％，21.8-33.3％和80.5-87.0％。当使用制造商的计算方法时，LymeSpot分析的效果同样差。内部分析法和LymeSpot分析法均无法诊断出活跃的LNB或监测抗生素治疗的成功。当使用制造商的计算方法时，LymeSpot分析的效果同样差。内部分析法和LymeSpot分析法均无法诊断出活跃的LNB或监测抗生素治疗的成功。当使用制造商的计算方法时，LymeSpot分析的效果同样差。内部分析法和LymeSpot分析法均无法诊断出活跃的LNB或监测抗生素治疗的成功。