DeFine.TB与Xpert⁃MTB/RIF诊断肺外结核的比较

Comparison of DeFine.TB and Xpert⁃MTB/RIF in the diagnosis of extrapulmonary tuberculosis

目的探讨结核分枝杆菌特异性细胞因子(DeFine.TB)联合结核分枝杆菌/利福平耐药实时荧光定量核酸扩增检测技术(Gene Xpert⁃MTB/RIF)检测在肺外结核病诊断的意义。方法收集2018年9月至2020年12月在西安交通大学第二附属医院住院确诊或临床诊断为肺外结核病患者52例纳入肺外结核组、非结核性肺外感染病人35例纳入非结核组。对所有患者分别进行血DeFine.TB、无菌体液DeFine.TB和无菌体液Gene Xpert⁃MTB/RIF检测,并对检测结果进行分析。结果52例临床确诊为肺外结核的患者中,血DeFine.TB、无菌体液DeFine.TB和Xpert MTB/RIF检测诊断肺外结核总阳性率分别为73.08%(38/52)、94.23%(49/52)和65.38%(34/52)。35例非肺外结核患者中,血、无菌体液DeFine.TB和无菌体液Xpert MTB/RIF检测诊断肺外结核阴性率分别为57.15%、77.14%和100.00%。在诊断肺外结核和非肺外结核感染时,血DeFine.TBγ⁃干扰素因子单阳和双因子检测差异无统计学意义(P均>0.05),无菌体液DeFine.TB双因子阳性和无菌体液Xpert MTB/RIF差异有统计学意义(χ^(2)=19.601、37.565,P均<0.05)。无菌体液DeFine.TB敏感度明显高于血DeFine.TB和无菌体液Xpert⁃MTB/RIF。无菌体液Xpert⁃MTB/RIF特异度明显高于血和无菌体液DeFine.TB。当无菌体液Xpert⁃MTB/RIF和DeFine.TB联合检测时,其敏感度和特异度分别为65.38%和100.00%。结论DeFine.TB和Xpert MTB/RIF联合检测肺外结核可明显提高诊断的特异度、阳性和阴性预测值,为临床早期识别肺外结核与非结核患者、及早抗结核治疗提供参考。

Objective To explore the significance of DeFine.TB combined with real⁃time fluorescence quantitative nucleic acid amplification(Xpert MTB/RIF)in diagnosis of extrapulmonary tuberculosis.Methods A total of 52 patients with extrapulmonary tuberculosis who were hospitalized or clinically diagnosed with extrapulmonary tuberculosis in the Second Affiliated Hospital of Xi'an Jiaotong University from September 2018 to December 2020 were recruited as the extrapulmonary tuberculosis group,and 35 patients with non⁃tuberculosis extrapulmonary infection were selected as the non⁃tuberculosis group.All specimens were detected by DeFine.TB of blood,DeFine.TB of sterile body fluid and Gene Xpert⁃MTB/RIF assay of sterile body fluid,respectively,and the results were analyzed.Results Among the 52 patients clinically diagnosed with extrapulmonary tuberculosis,the total positive rate of extrapulmonary tuberculosis diagnosed by blood DeFine.TB test,DeFine.TB and Xpert MTB/RIF detection of sterile body fluids were 73.08%(38/52),94.23%(49/52)and 65.38%(34/52),respectively.Among the 35 patients with nonextrapulmonary tuberculosis,the negative rates of blood,sterile body fluid DeFine.TB and sterile body fluid Xpert MTB/RIF for diagnosis of extrapulmonary tuberculosis were 57.15%,77.14%and 100.00%,respectively.When diagnosing extrapulmonary tuberculosis and non⁃extrapulmonary tuberculosis infection,there was no significant difference in blood DeFine.TBγ⁃interferon factor single⁃positive and double⁃factor detection(both P>0.05).When diagnosing extrapulmonary tuberculosis and non⁃extrapulmonary tuberculosis infection,there was a statistically significant difference between the double⁃factor positive rate of sterile body fluid DeFine.TB and Xpert MTB/RIF of sterile body fluid(χ^(2)=19.601,37.565,both P<0.05),and the sensitivity of sterile body fluid DeFine.TB was significantly higher than that of blood DeFine.TB and sterile body fluid Xpert⁃MTB/RIF.The specificity of sterile body fluid Xpert⁃MTB/RIF was significantly higher than that of blood and sterile body fluid DeFine.TB.When the sterile body fluid Xpert⁃MTB/RIF and DeFine.TB were combined for detection,the sensitivity and specificity were 65.38%and 100.00%,respectively.Conclusions DeFine.TB combined with Xpert⁃MTB/RIF to detect extrapulmonary tuberculosis can significantly improve the specificity,positive and negative predictive values of diagnosis,which provides a reference for early clinical identification of extrapulmonary tuberculosis and non⁃extrapulmonary tuberculosis and anti⁃tuberculosis treatment.