γ-干扰素诱导蛋白-10 mRNA检测技术对结核病辅助诊断的价值

The performance of interferon gamma-induced protein 10 mRNA detection technology in auxiliary diagnosis of tuberculosis

目的:评估以γ-干扰素诱导蛋白-10(interferon gamma-induced protein 10,IP-10)为靶标的检测技术(IP-10.TB)在结核病辅助诊断中的价值,并对比分析该检测技术与全血γ-干扰素释放试验(Quantiferon-TB Gold InTube,QFT-GIT)检测技术的一致性。方法:于2021年11月至2022年7月,在首都医科大学附属北京胸科医院连续性、前瞻性纳入疑似结核病患者作为研究对象,最终纳入158例。根据研究对象的临床表现、常规生化检测、结核病病原学检测、影像学检测和(或)病理学检测结果,将其分为确诊结核病组(88例)、临床诊断结核病组(29例)和非结核病组(41例)。所有研究对象同时行外周血IP-10.TB检测和QFT-GIT检测,采用受试者工作特征曲线分析两种检测技术的诊断价值,两种检测技术的一致性分析采用Kappa检验。结果:158例研究对象中,IP-10.TB检测不确定结果7例(4.4%),QFT-GIT检测不确定结果5例(3.2%),两者比较差异无统计学意义(χ^(2)=0.346,P=0.556)。在146例检测有效研究对象中,IP-10.TB诊断结核病的敏感度和特异度分别为96.3%(95%CI:90.1%~98.8%)和64.1%(95%CI:47.2%~78.3%),QFT-GIT诊断结核病的敏感度和特异度分别为97.2%(95%CI:91.4%~99.3%)和64.1%(95%CI:47.2%~78.3%)。两种检测技术的总符合率为92.5%(95%CI:88.2%~96.8%),阳性符合率为95.0%(95%CI:91.0%~98.9%),阴性符合率为82.1%(95%CI:68.0%~96.3%);一致性检验Kappa值为0.760(95%CI:0.624~0.895,P<0.001)。结论:IP-10.TB检测具有与QFT-GIT检测一致的诊断效能,可应用于结核病的辅助诊断。

Objective:To evaluate the performance of the interferon gamma-induced-protein 10(IP-10)assay(IP-10.TB)in auxiliary diagnosis of tuberculosis(TB),and analyze the concordance between IP-10.TB assay and the whole blood interferon gamma release assay(QFT-GIT).Methods:Suspected TB patients were prospectively and consecutively recruited in Beijing Chest Hospital,Capital Medical University between November 2021 and July 2022.According to the clinical manifestations,routine biochemical examinations,histopathological,radiological and(or)etiological examinations,a total of 158 cases with conclusive diagnosis were finally included,and the subjects were divided into definite TB group(88 cases),clinically diagnosed TB group(29 cases)and non-TB group(41 cases).IP-10.TB and QFT-GIT assays were simultaneously performed on peripheral blood samples.The diagnostic performance of IP-10.TB and QFT-GIT were analyzed using the receiver operating characteristic curve.Accordance of IP-10.TB and QFT-GIT was analyzed by Cohen’s Kappa test.Results:Among the 158 participants,there were 7 cases(4.4%)with indeterminate results of IP-10.TB and 5 cases(3.2%)with indeterminate results of QFT-GIT,respectively.No significant difference was detected in the ratio of indeterminate results between IP-10.TB assay and QFT-GIT(χ^(2)=0.346,P=0.556).The total sensitivity and specificity of IP-10.TB assay were 96.3%(95%CI:90.1%-98.8%)and 64.1%(95%CI:47.2%-78.3%),respectively;while the total sensitivity and specificity of QFT-GIT assay were 97.2%(95%CI:91.4%-99.3%)and 64.1%(95%CI:47.2%-78.3%),respectively.The total concordance rate of these two methods was 92.5%(95%CI:88.2%-96.8%),the positive concordance rate was 95.0%(95%CI:91.0%-98.9%)and the negative concordance rate was 82.1%(95%CI:68.0%-96.3%).The Cohen’s Kappa value was 0.760(95%CI:0.624-0.895,P<0.001)between IP-10.TB and QFT-GIT assays.Conclusion:These results showed that the performance of IP-10.TB was consistent with that of QFT-GIT for auxiliary diagnosis of TB.