全自动化学发光法检测γ-干扰素试验诊断结核病的临床应用

doi:10.6040/j.issn.1671-7554.0.2019.1048

摘要/Abstract

摘要： 目的探讨全自动化学发光法检测γ-干扰素试验诊断结核病临床应用价值。方法比较全自动化学发光法检测γ-干扰素试验与结核感染T细胞斑点试验(T-SPOT.TB)诊断结核病的性能差异。采用前瞻性研究,同步盲法进行,计划暂定招募结核病组(≥150例)、易与结核病混淆的非结核病组(≥100例)、随机健康人群(≥150例)。通过受试者工作特征(ROC)曲线比较两试验诊断性能的优劣性,Kappa检验评价两种诊断方法结果的一致性。结果实际收集400例样本,有效样本364例,其中结核病组141例,易与结核病混淆的非结核病组43例,随机健康人群180例。全自动化学发光法检测γ-干扰素试验、T-SPOT.TB试验［早期分泌靶向抗原6(ESAT-6)孔、培养滤液蛋白10(CFP-10)孔］的ROC曲线下面积(AUC)分别是0.897、0.884和0.879,Kappa值≈0.75。结论全自动化学发光法检测γ-干扰素试验和T-SPOT.TB试验诊断性能具有较好一致性,由于全自动化学发光法检测γ-干扰素试验操作全自动的优势,其在结核病诊断方面将有更好的临床应用价值。

关键词: 化学发光免疫分析法, 全自动, 结核病, γ-干扰素释放试验, 酶联免疫斑点法

Abstract: Objective To explore the clinical application value of the fully automatic chemiluminescence to detect interferon-γ test in diagnosis of tuberculosis. Methods To compare the diagnostic performance of the fully automatic chemiluminescence to detect interferon-γ test and T-cell spot of Tuberculosis(T-SPOT.TB)test in diagnosis of tuberculosis.The tuberculosis group(n>150), non-tuberculosis group easily confused with tuberculosis group(n>100), and healthy controls(n>150)were enrolled in the prospective and synchronous blind study. The diagnostic values of the two tests were compared with receiver operator characteristic(ROC)curve, and consistency of the results was evaluated with Kappa test. Results A total of 400 samples were collected, and 364 were valid, including 141 in tuberculosis group, 43 in non-tuberculosis group, and 180 healthy controls. The area under ROC curve(AUC)of the fully automatic chemiluminescence to detect interferon-γ test was 0.897, AUC of T-SPOT.TB test ［early secreted antigenic target-6(ESAT-6)hole and culture filtrate protein-10(CFP-10)hole］ was 0.884 and 0.879, respectively, and Kappa value was about 0.75. Conclusion The results of the fully automatic chemiluminescence to detect interferon-γ test and T-SPOT.TB test are consistent in diagnosis of tuberculosis. As the fully automatic chemiluminescence to detect interferon-γ test is automatically operated, it will have better clinical application value.

Key words: Chemiluminescence immunoassay, Fully Automatic, Tuberculosis, Interferon-gamma release assay, Enzyme-linked immunospot assay

中图分类号:

R378.91

李晓非,刘红伟,资敏,吕松琴,罗风,丘万,黄山. 全自动化学发光法检测γ-干扰素试验诊断结核病的临床应用[J]. 山东大学学报 (医学版), 2019, 57(11): 34-41.

LI Xiaofei, LIU Hongwei, ZI Min, LV Songqin, LUO Feng, QIU Wan, HUANG Shan. Clinical application of the fully automatic chemiluminescence to detect interferon-γ test in diagnosis of tuberculosis[J]. Journal of Shandong University (Health Sciences), 2019, 57(11): 34-41.

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