Efficacy comparison of two molecular drug sensitivity methods and phenotypic drug sensitivity testindetecting drug resistance of Mycobacterium tuberculosis

doi:10.19982/j.issn.1000-6621.20220259

Abstract

Abstract:

Objective:To evaluate the value of the gene chip method and fluorescence quantitative PCR-probe melting curve method in the direct detection of Mycobacterium tuberculosis (MTB) drug resistance in clinical specimens of tuberculosis patients. Methods:Forty-four clinical specimens of hospitalized tuberculosis patients in the Senior Department of Tuberculosis, the 8th Medical Center of Chinese PLA General Hospital were selected. Using the absolute concentration method of the traditional drug susceptibility test as the control, the drug resistance of MTB to rifampicin and isoniazid in clinical samples was directly detected by the gene chip method, and the drug resistance of MTB to rifampicin, isoniazid, and levofloxacin in the clinical specimens was directly detected by fluorescence quantitative PCR-probe melting curve method, to evaluate the sensitivity, specificity, and consistency of these two molecular drug susceptibility test methods. Results:The traditional drug susceptibility test was used as the standard, the sensitivity, specificity, consistency, and Kappa value of MTB to rifampicin resistance in 44 clinical samples directly detected by the gene chip method were 87.5% (14/16), 96.4% (27/28), 93.2% (41/44) and 0.851, respectively; for the isoniazid resistance were 85.7% (12/14), 96.7% (29/30), 93.2% (41/44) and 0.758, respectively. The sensitivity, specificity, consistency, and Kappa value of MTB to rifampin resistance in 44 clinical samples directly detected by the probe melting curve method were 87.5% (14/16), 89.3% (25/28), 88.6% (39/44), and 0.840, respectively; for isoniazid resistance were 85.7% (12/14), 83.3% (25/30), 84.1% (37/44), and 0.653, respectively; for the levofloxacin resistance were 85.0% (17/20), 100.0% (24/24), 93.2% (41/44), and 0.861, respectively. Conclusion:The gene chip method and probe melthing curve method have a high consistency with the absolute concentration method in detecting the drug resistant of MTB to rifampicin, isoniazid (and levofloxain) in clinical specimens,which can be used as a reference for clinical chemotherapy.

Key words: Mycobacterium tuberculosis, Drug resistance, Molecular diagnostic techniques, Polymerase chain reaction, Contrast sensitivity

CLC Number:

R52
U472.9

Sun Wenna, Zhang Junxian, Zhang Xiushuang, Wang Xiaomeng, Lin Wen, Liang Yan, Wang Jie, Wu Xueqiong. Efficacy comparison of two molecular drug sensitivity methods and phenotypic drug sensitivity testindetecting drug resistance of Mycobacterium tuberculosis[J]. Chinese Journal of Antituberculosis, 2022, 44(10): 1016-1021. doi: 10.19982/j.issn.1000-6621.20220259

Figures/Tables 5

References 20

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传统药敏试验绝对浓度法	芯片法(例)		合计 (例)	敏感度 (%, 95%CI)	特异度 (%,95%CI)	准确度 (%,95%CI)	Kappa值 (95%CI)
传统药敏试验绝对浓度法	耐药	敏感	合计 (例)	敏感度 (%, 95%CI)	特异度 (%,95%CI)	准确度 (%,95%CI)	Kappa值 (95%CI)
利福平				87.5(60.4~97.8)	96.4(79.8~99.8)	93.2(81.3~98.6)	0.851(0.688~1.000)
耐药	14	2	16
敏感	1	27	28
合计	15	29	44
异烟肼				85.7(56.2~97.5)	96.7(81.0~99.8)	93.2(81.3~98.6)	0.758(0.588~0.958)
耐药	12	2	14
敏感	1	29	30
合计	13	31	44

传统药敏试验绝对浓度法	熔解曲线法
传统药敏试验绝对浓度法	耐药	敏感
高耐(17)	gyrA 88~94(16)	1
低耐(3)	gyrA 88~94(1)	2
敏感(24)	0	24
合计	17	27