Efficacy analysis of GeneXpert MTB/RIF and TB-DNA fluorescent PCR methods for detecting pus samples in the diagnosis of extrapulmonary tuberculosis

doi:10.19982/j.issn.1000-6621.20230304

Abstract

Abstract:

Objective: To compare the diagnostic value of Mycobacterium tuberculosis (MTB)/Rifampicin resistance real-time fluorescent quantitative nucleic acid amplification assay (GeneXpert MTB/RIF, Xpert) and tuberculosis/non-tuberculosis mycobacterium PCR fluorescent probe (TB-DNA) in detecting extra-pulmonary pus samples for tuberculosis. Methods: A retrospective analysis was performed on 388 cases of suspected extrapulmonary tuberculosis treated in Hangzhou Red Cross Hospital from January 2021 to February 2023, and pus samples were obtained from the lesion site. The pus samples were detected by Xpert, TB-DNA and BACTEC MGIT 960 liquid culture (MGIT 960 culture), respectively. To compare the efficacy of two fluorescence PCR methods in the diagnosis of extrapulmonary tuberculosis in pus samples, using clinical diagnosis as a reference standard. Results: Using a clinical diagnosis as the standard, the sensitivity, specificity, and AUC of Xpert and TB-DNA were 84.15% (276/328), 100.00% (60/60), 0.92 and 84.45% (277/328),100.00% (60/60), 0.92, respectively. Using culture as the gold standard, the sensitivity, specificity, and AUC of Xpert and TB-DNA were 89.90% (89/99), 35.29% (102/289), 0.63 and 92.93% (92/99), 35.99% (104/289), 0.65, respectively. Consistency analysis showed that TB-DNA and Xpert were highly consistent with clinical diagnosis (Kappa values were 0.62, 0.63), MGIT 960 culture showed very low consistency with clinical diagnosis (Kappa value was 0.12). Among the 388 samples, TB-DNA and Xpert simultaneously detected 262 cases of MTB positivity, but neither method detected 97 cases. There were 15 cases of TB-DNA positivity and Xpert negativity, and 14 cases of TB-DNA negativity and Xpert positivity. Xpert detected 276 cases of MTB positivity, 12 cases of rifampicin resistance, and the rifampicin resistance rate was 4.35% (12/276). Conclusion: After receiving pus samples from newly treated patients with extrapulmonary tuberculosis, TB-DNA could be used for preliminary screening, and positive samples could be obtained by other detection methods for drug resistance information.

Key words: Molecular diagnostic technology, Examination of pus, Evaluation studies

CLC Number:

R52
R446

Shao Yanqin, Zhu Mingzhi, Dai Lingshan, Peng Lijun, Mei Bin, Fang Tingting, Cai Long. Efficacy analysis of GeneXpert MTB/RIF and TB-DNA fluorescent PCR methods for detecting pus samples in the diagnosis of extrapulmonary tuberculosis[J]. Chinese Journal of Antituberculosis, 2023, 45(12): 1158-1163. doi: 10.19982/j.issn.1000-6621.20230304

Figures/Tables 5

References 12

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项目	临床诊断		敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
项目	结核病组(328例)	非结核病组(60例)	敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	Kappa值
Xpert			84.15	100.00	100.00	53.57	0.62
阳性	276	0
阴性	52	60
TB-DNA			84.45	100.00	100.00	54.05	0.63
阳性	277	0
阴性	51	60
MGIT 960培养			30.18	100.00	100.00	20.76	0.12
阳性	99	0
阴性	229	60

项目	MGIT 960液体培养		敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)
项目	阳性(99例)	阴性(289例)	敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)
Xpert			89.90	35.29	32.25	91.07
阳性	89	187
阴性	10	102
TB-DNA			92.93	35.99	33.21	93.69
阳性	92	185
阴性	7	104

病例号	发病部位	Xpert(细菌载量)	TB-DNA (Ct值)	培养结果	病例号	发病部位	Xpert(细菌载量)	TB-DNA (Ct值)	培养结果
4	骨关节	阴性	阳性(33)	阴性	11	淋巴结	阳性(低)	阴性	阴性
13	骨关节	阴性	阳性(34)	阴性	189	淋巴结	阳性(极低)	阴性	阴性
35	骨关节	阴性	阳性(33)	阳性	218	淋巴结	阳性(低)	阴性	阴性
41	骨关节	阴性	阳性(33)	阴性	219	其他	阳性(低)	阴性	阴性
49	骨关节	阴性	阳性(34)	阴性	220	腔体	阳性(低)	阴性	阴性
88	骨关节	阴性	阳性(37)	阳性	233	腔体	阳性(低)	阴性	阴性
109	淋巴结	阴性	阳性(31)	阴性	262	腔体	阳性(低)	阴性	阴性
125	淋巴结	阴性	阳性(38)	阴性	273	腔体	阳性(低)	阴性	阴性
157	淋巴结	阴性	阳性(33)	阳性	276	腔体	阳性(极低)	阴性	阴性
245	淋巴结	阴性	阳性(25)	阴性	288	腔体	阳性(极低)	阴性	阴性
321	腔体	阴性	阳性(34)	阴性	324	腔体	阳性(中)	阴性	阴性
336	腔体	阴性	阳性(33)	阴性	331	腔体	阳性(低)	阴性	阴性
356	腔体	阴性	阳性(36)	阴性	377	腔体	阳性(极低)	阴性	阴性
364	腔体	阴性	阳性(34)	阴性	386	腔体	阳性(低)	阴性	阴性
372	腔体	阴性	阳性(39)	阴性

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