Objectives

Analyse alternative methods of intrathecal antibody detection by comparing chemiluminescent immunoassay (CLIA) and enzyme-linked immunosorbent assay (ELISA) techniques to determine if CLIA can replace ELISA in the diagnosis of CNS infections.

Methods

A panel of 280 paired samples—cerebrospinal fluid (CSF) and serum—with known antibody reactivities (Varicella, n = 60; Measles, n = 120) and negative samples (n = 100) were used to evaluate the performance of six serological test kits (Enzygnost, VirClia®, and Serion ELISA (Measles and Variella).

Results

For Measles virus IgG, the VirClia® IgG monotest revealed 97% and 94% positive and negative agreement to the Enzygnost as reference test, respectively. In contrast, Serion ELISA kits yielded values of 18% and 90%. For the Varicella Zoster virus (VZV) IgG, the VirClia® IgG monotest showed 97% and 90% positive and negative agreement compared to Enzygnost. The Serion ELISA kits showed values of 55% and 86%, respectively. ROC analysis revealed that the areas under the curve for Measles and VZV IgGs were 0.7 and 0.852, respectively, using the Serion kit, and 0.963 and 0.955, for Vircell S.L CLIA technique. VirClia® monotest values were calculated using an antibody index cut-off of 1.3.

Conclusion

The findings indicate that CLIA testing can improve antibody detection in CSF samples, aiding the diagnosis of infectious neurological impairments.

中文翻译：

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通过商业 IgG 化学发光免疫分析与两种 ELISA 的评估和比较，检测用于水痘和麻疹诊断的鞘内 IgG 抗体

目标

通过比较化学发光免疫测定 (CLIA) 和酶联免疫吸附测定 (ELISA) 技术来分析鞘内抗体检测的替代方法，以确定 CLIA 是否可以替代 ELISA 诊断中枢神经系统感染。

方法

使用一组 280 个配对样本（脑脊液 (CSF) 和血清）和已知抗体反应性（水痘，n  = 60；麻疹，n  = 120）和阴性样本（n  = 100）来评估六种血清学测试的性能试剂盒（Enzygnost、VirClia® 和 Serion ELISA（麻疹和水痘）。

结果

对于麻疹病毒IgG，VirClia® IgG 单测试显示与作为参考测试的 Enzygnost 的阳性率和阴性率分别为 97% 和 94%。相比之下，Serion ELISA 试剂盒的得出值分别为 18% 和 90%。对于 水痘带状疱疹病毒(VZV) IgG，与 Enzygnost 相比，VirClia® IgG 单测试显示出 97% 和 90% 的阳性和阴性一致性。 Serion ELISA 试剂盒的显示值分别为 55% 和 86%。 ROC 分析显示，使用 Serion 试剂盒，麻疹和 VZV IgG的曲线下面积分别为 0.7 和 0.852，使用 Vircell SL CLIA 技术，曲线下面积分别为 0.963 和 0.955。 VirClia® 单测试值是使用抗体指数截止值 1.3 计算的。

结论

研究结果表明，CLIA 检测可以改善脑脊液样本中的抗体检测，有助于诊断感染性神经损伤。