市售酶联免疫吸附测定试剂盒在肺外结核病诊断中的诊断性能

Diagnostic performance of commercially available enzyme-linked immunosorbent assay kit in the diagnosis of extrapulmonary tuberculosis.

作者信息

Sankar Manimuthu Mani, Balooni Veena, Singh Jitendra, Singh Sarman

机构信息

Department of Laboratory Medicine, Division of Clinical Microbiology and Molecular Medicine, All India Institute of Medical Sciences, New Delhi, India.

出版信息

J Lab Physicians. 2013 Jan;5(1):11-6. doi: 10.4103/0974-2727.115902.

DOI:10.4103/0974-2727.115902

PMID:24014961

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3758697/

Abstract

OBJECTIVES

Antibody based serodiagnosis tests for tuberculosis (TB) was used widely in developed and developing countries. Pathozyme Myco(®) immunoglobulin (Ig) M, IgA, and IgG were evaluated in pulmonary TB in many studies.

MATERIALS AND METHODS

In this study we assessed this commercially available kit in detecting extrapulmonary TB (EPTB).

RESULTS

A total of 354 subjects were recruited for the study, of which 217 (61.2%) were EPTB patients and 137 (38.7%) were subjects with no suggestive TB. The mean age was 29.7 ± 13.7 and 31.2 ± 15.2 years, respectively for two groups. Serum samples were tested for IgM, IgA, and IgG using Pathozyme Myco(®) IgM, IgA, and IgG kit. The individual specificity rates of IgM, IgA, and IgG were 70.8% (95% confidence interval (CI): 62.7-77.7), 77.3% (95% CI: 68.6-83.5), and 68.6%. (95% CI: 60.4-75.7); while their sensitivity was 29% (95% CI: 23.4-35.4), 24.4% (95% CI: 19.1-30.5), and 34.5% (95% CI: 28.5-41.1); respectively.

CONCLUSION

The serological tests either singly or in combination failed or performed poorly to diagnose EPTB.

摘要

目的

基于抗体的结核病血清学诊断检测在发达国家和发展中国家广泛应用。许多研究对Pathozyme Myco®免疫球蛋白（Ig）M、IgA和IgG在肺结核中的情况进行了评估。

材料与方法

在本研究中，我们评估了这种市售试剂盒在检测肺外结核（EPTB）方面的性能。

结果

本研究共招募了354名受试者，其中217名（61.2%）为EPTB患者，137名（38.7%）为无结核病迹象的受试者。两组的平均年龄分别为29.7±13.7岁和31.2±15.2岁。使用Pathozyme Myco® IgM、IgA和IgG试剂盒检测血清样本中的IgM、IgA和IgG。IgM、IgA和IgG的个体特异性率分别为70.8%（95%置信区间（CI）：62.7 - 77.7）、77.3%（95% CI：68.6 - 83.5）和68.6%（95% CI：60.4 - 75.7）；而它们的敏感性分别为29%（95% CI：23.4 - 35.4）、24.4%（95% CI：19.1 - 30.5）和34.5%（95% CI：28.5 - 41.1）。