Application of GeneXpert MTB/RIF combined with linear probe detection technology in the diagnosis of drug-resistant tuberculosis

doi:10.3969/j.issn.1000-6621.2021.10.022

Abstract

Abstract:

Between December 2017 and December 2018, a total of 3903 sputum samples from suspected primary tuberculosis patients from 19 designated tuberculosis hospitals in Shanghai were simultaneously tested by sputum smear, BACTEC MGIT 960 liquid culture (liquid culture) and GeneXpert MTB/RIF (GeneXpert) assay, to compare the efficacy of GeneXpert in detecting Mycobacterium tuberculosis. Of the clinical strain from tuberculosis patients diagnosed in the same period, 707 were tested for rifampicin resistance using linear probe assays (LPA). If the results were inconsistent with those of GeneXpert, the sputum samples were then re-tested with the minimum inhibitory concentration (MIC) for culture-positive strains and GeneXpert. The consistency between the rifampicin resistance detected by GeneXpert in sputum samples of the same patient and the rifampicin resistance detected by LPA in culture positive strains were compared. The positive detection rates of sputum smear, liquid culture and GeneXpert were 19.63% (766/3903), 25.93% (1012/3903) and 25.16% (982/3903), respectively. The positive detection rate of GeneXpert was significantly higher than that of sputum smear (χ²=34.390, P<0.001), but lower than that of liquid culture (χ²=0.610, P=0.436). Take liquid culture results (MTB positive) as the standard, the sensitivity and specificity were 81.23% (822/1012) and 94.47% (2731/2891) of the GeneXpert assay, and 64.92% (657/1012) and 96.23% (2782/2891) of sputum smear. GeneXpert was used to detect rifampicin resistance in sputum samples, and LPA was used to detect rifampicin resistance in cultured positive strains of the same patient. The coincidence rate of the two molecular detection techniques was 98.30% (695/707). The coincidence rate of GeneXpert and LPA in detecting rifampicin resistance was high, however, there still might be missed detection or over diagnosis. If the results were inconsistent, other test methods should be used to provide laboratory basis for accurate diagnosis.

Key words: Tuberculosis, Drug resistance, Molecular diagnostic techniques, Molecular probe techniques, Rifampin

LI Jing, YU Chen-lei, ZHANG Yang-yi, WANG Li-li, SHEN Xu-hui, CHEN Wei, JIANG Yuan. Application of GeneXpert MTB/RIF combined with linear probe detection technology in the diagnosis of drug-resistant tuberculosis[J]. Chinese Journal of Antituberculosis, 2021, 43(10): 1102-1106. doi: 10.3969/j.issn.1000-6621.2021.10.022

Figures/Tables 2

References 14

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检测方法结果	液体培养(份)			敏感度 [%(95%CI)]	特异度 [%(95%CI)]	符合率 [%(95%CI)]	阳性预测值 [%(95%CI)]	阴性预测值 [%(95%CI)]	Kappa值 (95%CI)
检测方法结果	阳性^a	阴性		敏感度 [%(95%CI)]	特异度 [%(95%CI)]	符合率 [%(95%CI)]	阳性预测值 [%(95%CI)]	阴性预测值 [%(95%CI)]	Kappa值 (95%CI)
痰涂片				64.92 (61.88~67.85)	96.23 (95.45~96.88)	88.11 (87.06~89.09)	85.77 (83.05~88.13)	88.68 (87.51~89.76)	0.664 (0.636~0.692)
阳性	657		109
阴性	355		2782
GeneXpert				81.23 (78.65~83.56)	94.47 (93.55~95.26)	91.03 (90.10~91.89)	83.71 (81.21~85.93)	93.50 (92.52~94.35)	0.764 (0.741~0.788)
阳性	822		160
阴性	190		2731

菌株编号	LPA^a	GeneXpert^a (痰样本检测结果)	GeneXpert^a (培养阳性菌株检测结果)	MIC^b (μg/ml)
0368	敏感	耐药[probe E(529~533)]	耐药[probe E(529~533)]	敏感(1.0)
0452	敏感	耐药[probe E(529~533)]	耐药[probe E(529~533)]	耐药(4.0)
0527	敏感	耐药[probe A(507~511)]	敏感	敏感(0.25)
0611	耐药[ropB MUT 3(S531L)]	敏感	耐药[probe E(529~533)]	耐药(16.0)
0648	敏感	耐药[probe E(529~533)]	耐药[probe E(529~533)]	耐药(2.0)
0821	耐药[ropB MUT 3(S531L)]	敏感	耐药[probe E(529~533)]	耐药(16.0)
0867	敏感	耐药[probe A(507~511)]	敏感	敏感(0.12)
0885	敏感	耐药[probe E(529~533)]	耐药[probe E(529~533)]	敏感(1.0)
0998	耐药[ropB MUT 3(S531L)]	敏感	耐药[probe E(529~533)]	耐药(16.0)
1043	耐药[ropB MUT 3(S531L)]	敏感	耐药[probe E(529~533)]	耐药(8.0)
1441	敏感	耐药[probe B(512~518)]	耐药[probe B(512~518)]	混合生长
1458	耐药[ropB MUT 3(S531L)]	敏感	耐药[probe E(529~533)]	耐药(16.0)

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