Sun W W, Gu J, Fan L
Shanghai Clinic and Research Center of Tuberculosis, Department of Tuberculosis, Shanghai Key Laboratory of Tuberculosis, Shanghai Pulmonary Hospital, Tongji University School of Medicine, Shanghai 200433, China.
Zhonghua Jie He He Hu Xi Za Zhi. 2021 Feb 12;44(2):96-100. doi: 10.3760/cma.j.cn112147-20200316-00343.
To investigate the diagnostic value of metagenomic next generation sequencing(mNGS)for different types of tuberculosis(TB). A retrospective analysis was performed on suspected TB patients admitted to Shanghai Pulmonary Hospital from January 1, 2019 to December 31, 2019. The patients underwent mNGS test, acid-fast staining smear, tuberculosis (MTB) culture and Xpert MTB/RIF(Xpert). A total of 205 TB suspects were finally included, including 120 males and 85 females, with a median age of 34 (16, 70) years. There were 165 cases of TB, including 92 males and 73 females, with a median age of 30 (12, 67) years. There were 40 non-TB patients, 28 males and 12 females, with a median age of 44.6 (24, 78) years, including 28 cases of infectious diseases and 12 cases of malignant tumors. With the final diagnosis as the reference standard, the diagnostic efficiency of mNGS in different types of tuberculosis (including pulmonary tuberculosis and extrapulmonary tuberculosis) and differences in diagnostic sensitivities between mNGS and other detection methods were calculated, respectively. <0.05 was considered to be statistically different. With clinical diagnosis as the reference standard, the sensitivity of mNGS to diagnose TB in this study was 60% (99/165, 95%: 0.53-0.67), and the specificity was 100% (40/40, 95% 0.90-1.00). The positive predictive value was 100% (99/99, 95%: 0.95-1.00), and the negative predictive value was 37.74% (40/106, 95%: 0.29-0.48). The sensitivity of mNGS in TB was 60% (99/165), higher than that of smear (10.9%, 18/165), Xpert(43.64%, 72/165) and culture (23.03%, 38/165). All the differences were statistically significant (=0.00). The sensitivity of mNGS in pulmonary TB was 59%(59/100), which was significantly higher than that of smear (15%, 15/100) and culture (26%, 26/100), all <0.001, but the difference was not statistically significant compared with Xpert (52%,52/100, =0.09). In the extrapulmonary tuberculosis (EPTB), the sensitivity of mNGS was 61.54% (40/65), higher than that of acid fast staining(4.62%,3/65), Xpert (30.77%, 20/65)and culture (18.45%, 12/65). All the differences were statistically significant (all <0.001). The mNGS was rapid and efficient in detection of MTB, and was superior to other traditional diagnostic methods for TB, especially for EPTB.
探讨宏基因组二代测序（mNGS）对不同类型结核病（TB）的诊断价值。对2019年1月1日至2019年12月31日收治于上海肺科医院的疑似结核病患者进行回顾性分析。患者接受了mNGS检测、抗酸染色涂片、结核分枝杆菌（MTB）培养及Xpert MTB/RIF（Xpert）检测。最终纳入205例结核病疑似患者，其中男性120例，女性85例，中位年龄为34（16，70）岁。其中结核病患者165例，男性92例，女性73例，中位年龄为30（12，67）岁。非结核病患者40例，男性28例，女性12例，中位年龄为44.6（24，78）岁，其中传染病28例，恶性肿瘤12例。以最终诊断为参考标准，分别计算mNGS对不同类型结核病（包括肺结核和肺外结核）的诊断效率以及mNGS与其他检测方法诊断敏感性的差异。P<0.05认为差异有统计学意义。以临床诊断为参考标准，本研究中mNGS诊断结核病的敏感性为60%（99/165，95%CI：0.53 - 0.67），特异性为100%（40/40，95%CI：0.90 - 1.00）。阳性预测值为100%（99/99，95%CI：0.95 - 1.00），阴性预测值为37.74%（40/106，95%CI：0.29 - 0.48）。mNGS在结核病中的敏感性为60%（99/165），高于涂片（10.9%，18/165）、Xpert（43.64%，72/165）和培养（23.03%，38/165）。所有差异均有统计学意义（P = 0.00）。mNGS在肺结核中的敏感性为59%（59/100），显著高于涂片（15%，15/100）和培养（26%，26/100），均P<0.001，但与Xpert（52%，52/100，P = 0.09）相比差异无统计学意义。在肺外结核（EPTB）中，mNGS的敏感性为61.54%（40/65），高于抗酸染色（4.62%，3/65）、Xpert（30.77%，20/65）和培养（18.45%，12/65）。所有差异均有统计学意义（均P<0.001）。mNGS检测MTB快速高效，优于其他传统结核病诊断方法，尤其对于肺外结核。
