A multicenter clinical study on the diagnostic value of nanopore sequencing technology in patients with smear-negative tuberculosis

doi:10.19982/j.issn.1000-6621.20240481

Abstract

Abstract:

Objective: To analyze the diagnostic value of nanopore sequencing technology in patients with smear-negative pulmonary tuberculosis (PTB). Methods: In this study, 107 smear-negative patients with suspected PTB admitted to infectious disease hospitals from Beijing, Anhui, Qinghai and Jilin Provinces from September 2021 to April 2022 were enrolled as research subjects. Samples of these cases were subjected to BACTEC MGIT 960 liquid culture (MGIT 960 culture), GeneXpert MTB/RIF (Xpert) assay and nanopore sequencing. The final clinical diagnosis was used as reference standard to evaluate diagnostic accuracy of the three methods for detecting PTB. Results: Among the 107 patients with suspected PTB, 70 cases (65.42%) were finally diagnosed as PTB,15 cases (14.02%) were nontuberculous mycobacteria and 22 cases (20.56%) were non-TB. The sensitivities of nanopore sequencing technology, MGIT 960 culture and Xpert detection were 84.29% (59/70), 37.14% (26/70) and 41.43% (29/70), respectively, and their specificities were 86.49% (32/37), 75.68% (28/37) and 97.30% (36/37), respectively. Their Youden index were 0.71, 0.13, and 0.39, respectively. Their AUC values were 0.854 (95%CI: 0.773-0.935), 0.694 (95%CI: 0.596-0.792) and 0.564 (95%CI: 0.451-0.677), respectively. Conclusion: Nanopore sequencing technology has better diagnostic performance than Xpert and MGIT 960 culture in the detection of smear-negative PTB.

Key words: Tuberculosis, pulmonary, Bronchoalveolar lavage fluids, Nanotechnology, Multicenter study

CLC Number:

R521
R446

Yan Xiaojing, Wang Yujin, Wang Jun, Jing Wei, Li Xuelian, Cheng Jie, Yang Guoli, Wang Yuqing, Chu Naihui, Nie Wenjuan, Jiao Xiaoke. A multicenter clinical study on the diagnostic value of nanopore sequencing technology in patients with smear-negative tuberculosis[J]. Chinese Journal of Antituberculosis, 2025, 47(2): 169-174. doi: 10.19982/j.issn.1000-6621.20240481

Figures/Tables 3

References 13

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特征	患者例数	构成比(%)
性别
男性	69	64.49
女性	38	35.51
年龄组(岁)
≤30	22	20.56
31~40	11	10.28
41~50	17	15.89
51~60	26	24.30
>60	31	28.97
疾病诊断
肺结核	70	65.42
非肺结核	37	34.58
纳米孔测序
阳性	64	59.81
阴性	43	40.19
MGIT 960培养
阳性	35	32.71
阴性	72	67.29
Xpert
阳性	30	28.04
阴性	77	71.96
临床最终诊断结果阳性
纳米孔测序阴性;Xpert 阴性;MGIT 960培养阴性	11	10.28
纳米孔测序阳性;Xpert 阴性;MGIT 960培养阴性	25	23.36
纳米孔测序阳性;Xpert 阴性;MGIT 960培养阳性	5	4.67
纳米孔测序阳性;Xpert 阳性;MGIT 960培养阴性	8	7.48
纳米孔测序阳性;Xpert阳性;MGIT 960培养阳性	21	19.63
临床最终诊断结果阴性
纳米孔测序阴性;Xpert阴性;MGIT 960培养阴性	25	23.36
纳米孔测序阴性;Xpert阴性;MGIT 960培养阳性	6	5.61
纳米孔测序阴性;Xpert阳性;MGIT 960培养阴性	1	0.93
纳米孔测序阳性;Xpert阴性;MGIT 960培养阴性	2	1.87
纳米孔测序阳性;Xpert阴性;MGIT 960培养阳性	3	2.80

检验方法	临床诊断		敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	约登指数	符合率 (%)
检验方法	阳性(例)	阴性(例)	敏感度 (%)	特异度 (%)	阳性预测值(%)	阴性预测值(%)	约登指数	符合率 (%)
MGIT 960培养			37.14	75.68	74.29	38.89	0.13	50.47
阳性	26	9
阴性	44	28
Xpert			41.43	97.30	96.67	46.75	0.39	60.75
阳性	29	1
阴性	41	36
纳米孔测序			84.29	86.49	92.19	74.42	0.71	85.05
阳性	59	5
阴性	11	32

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