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评估三种全自动免疫分析系统检测抗β2糖蛋白I抗体IgA的性能

Evaluation of three fully automated immunoassay systems for detection of IgA anti-beta 2-glycoprotein I antibodies.

作者信息

Pérez D, Martínez-Flores J A, Serrano M, Lora D, Paz-Artal E, Morales J M, Serrano A

机构信息

Department of Immunology, Instituto de Investigación Hospital Universitario 12 de Octubre, Madrid, Spain.

Epidemiology Section, Instituto de Investigación Hospital Universitario 12 de Octubre, Madrid, Spain.

出版信息

Int J Lab Hematol. 2016 Oct;38(5):560-8. doi: 10.1111/ijlh.12543. Epub 2016 Jul 20.

DOI:10.1111/ijlh.12543
PMID:27435259
Abstract

INTRODUCTION

In recent years, we have been witnessing increased clinical interest in the determination of IgA anti-beta 2-glycoprotein I (aB2GPI) antibodies as well as increased demand for this test. Some ELISA-based diagnostic systems for IgA aB2GPI antibodies detection are suboptimal to detect it. The aim of our study was to determine whether the diagnostic yield of modern detection systems based on automatic platforms to measure IgA aB2GPI is equivalent to that of the well-optimized ELISA-based assays.

METHODS

In total, 130 patients were analyzed for IgA aB2GPI by three fully automated immunoassays using an ELISA-based assay as reference. The three systems were also analyzed for IgG aB2GPI with 58 patients.

RESULTS

System 1 was able to detect IgA aB2GPI with good sensitivity and kappa index (99% and 0.72, respectively). The other two systems had also poor sensitivity (20% and 15%) and kappa index (0.10 and 0.07), respectively. On the other hand, kappa index for IgG aB2GPI was >0.89 in the three systems.

CONCLUSION

Some analytical methods to detect IgA aB2GPI are suboptimal as well as some ELISA-based diagnostic systems. It is important that the scientific community work to standardize analytical methods to determine IgA aB2GPI antibodies.

摘要

引言

近年来,我们目睹了临床对IgA抗β2糖蛋白I(aB2GPI)抗体检测的兴趣日益增加,对该检测的需求也不断上升。一些基于酶联免疫吸附测定(ELISA)的用于检测IgA aB2GPI抗体的诊断系统在检测方面并不理想。我们研究的目的是确定基于自动平台测量IgA aB2GPI的现代检测系统的诊断效能是否等同于优化良好的基于ELISA的检测方法。

方法

总共130例患者通过三种全自动免疫测定法检测IgA aB2GPI,并以基于ELISA的检测方法作为参考。还对58例患者使用这三种系统检测了IgG aB2GPI。

结果

系统1能够以良好的灵敏度和kappa指数检测IgA aB2GPI(分别为99%和0.72)。另外两个系统的灵敏度也较差(分别为20%和15%),kappa指数也较低(分别为0.10和0.07)。另一方面,三种系统中IgG aB2GPI的kappa指数均>0.89。

结论

一些检测IgA aB2GPI的分析方法以及一些基于ELISA的诊断系统并不理想。科学界致力于规范检测IgA aB2GPI抗体的分析方法非常重要。

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