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通过评估和比较商业 IgG 化学发光免疫分析与两种 ELISA ,检测水痘和麻疹的鞘内 IgG 抗体以进行诊断。

Detection of intrathecal IgG antibody for varicella and measles diagnosis by evaluation and comparison of a commercial IgG chemiluminescent immunoassay with two ELISAs.

机构信息

Vircell S.L., Parque Tecnológico de la Salud, C/ Avicena, 8, 18016, Granada, Spain.

Department of Microbiology, Faculty of Pharmacy, University of Granada, Granada, Spain.

出版信息

Eur J Clin Microbiol Infect Dis. 2024 Jun;43(6):1139-1148. doi: 10.1007/s10096-024-04822-x. Epub 2024 Apr 13.

DOI:10.1007/s10096-024-04822-x
PMID:38613705
Abstract

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.

摘要

目的

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

方法

使用 280 对已知抗体反应性(水痘,n=60;麻疹,n=120)和阴性样本(n=100)的脑脊液(CSF)和血清配对样本进行分析,以评估六种血清学试剂盒(Enzygnost、VirClia®和 Serion ELISA(麻疹和 Variella)的性能。

结果

对于麻疹病毒 IgG,VirClia® IgG 单测试与 Enzygnost 参考测试相比,阳性和阴性符合率分别为 97%和 94%。相比之下,Serion ELISA 试剂盒的数值分别为 18%和 90%。对于水痘带状疱疹病毒(VZV)IgG,与 Enzygnost 相比,VirClia® IgG 单测试的阳性和阴性符合率分别为 97%和 90%。Serion ELISA 试剂盒的数值分别为 55%和 86%。ROC 分析显示,使用 Serion 试剂盒时,麻疹和 VZV IgG 的曲线下面积分别为 0.7 和 0.852,而使用 Vircell S.L. CLIA 技术时分别为 0.963 和 0.955。VirClia®单测试值使用抗体指数截断值 1.3 计算。

结论

研究结果表明,CLIA 检测可以提高 CSF 样本中的抗体检测水平,有助于诊断感染性神经损伤。

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