New TruArray technology for detection of Mycobacterium tuberculosis and drug resistance from sputum specimen

doi:10.3969/j.issn.1000-6621.2018.10.002

Abstract

Abstract:

Objective To evaluate the performance of a new gel element arrays gel-drop (TruArray) chip for the detection of Mycobacterium tuberculosis (MTB) and rifampicin (RFP) and isoniazid (INH) resistance from sputum specimen. Methods A total of 149 samples provided by pulmonary tuberculosis suspected patients from Capital Medical University Affiliated Beijing Chest Hospital were selected for smear microscopy, MGIT 960 liquid culture, TruArray and GeneXpert MTB/RIF (GeneXpert) test, and perform identification sequencing, MGIT 960 drug susceptibility test and drug resistance-related gene sequencing for liquid culture positive strains. Analyze the performance of TruArray test for MTB and its drug resistance detection in sputum samples. Results The detection rates of MTB in liquid culture, GeneXpert and TruArray test were 32.2% (48/149), 53.7% (80/149) and 57.0% (85/149), respectively. There was no statistical difference in the detection rates of TruArray and GeneXpert (χ ²=0.34, P=0.560), but the positive rate of TruArray test was significantly higher than that of liquid culture (χ ²=18.59, P<0.01). With the MGIT 960 liquid culture result as standard, the sensitivity and specificity of TruArray test for MTB detection in sputum samples were 97.9% (47/48) and 61.4% (62/101), respectively. Compared with GeneXpert result, the sensitivity and specificity of TruArray test for MTB detection were 97.5% (78/80) and 88.4% (61/69), respectively. Based on the results of MGIT 960 drug susceptibility test, the sensitivity and specificity of TruArray test for RFP resistance detection were 91.7% (11/12) and 96.8% (30/31), respectively. Compared with GeneXpert assay, the sensitivity and specificity of the TruArray test for RFP resistance detection were 85.0% (17/20) and 97.9% (47/48), respectively. Based on the sequencing results of drug resistance genes, the sensitivity and specificity of TruArray test for RFP resistance detection was 92.3% (12/13) and 100.0% (30/30), respectively. Based on the results of MGIT 960 liquid susceptibility test, the sensitivity and specificity of the TruArray test for INH resistance detection were 78.6% (11/14) and 93.8% (30/32), respectively. Using the sequencing results of drug resistance genes as the criterion, the sensitivity and specificity of TruArray test for INH resistance detection were 100.0% (11/11) and 94.3% (33/35), respectively. Conclusion TruArray test is a rapid and reliable diagnostic method, it has a very good application prospect in tuberculosis and multidrug resistance tuberculosis detection.

Key words: Mycobacterium tuberculosis, Multidrug-resistant tuberculosis, Microchip analytical procedures, Laboratory techniques and procedures, Comparative study

Dan SU,Qiang LI,Nan-ying CHE,Xi-chao OU,Bing ZHAO,Yan-lin ZHAO,Hai-rong HUANG. New TruArray technology for detection of Mycobacterium tuberculosis and drug resistance from sputum specimen[J]. Chinese Journal of Antituberculosis, 2018, 40(10): 1034-1039. doi: 10.3969/j.issn.1000-6621.2018.10.002

Figures/Tables 4

References 14

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基因名称	引物序列 (5'~3')	片段长度(bp)
16S rRNA	F: GGCCTAACCCTCGGGAGGGAG	440
	R: CCCGAGGCATATCGCAGCCTC
rpoB	F: ACCGACGACATCGACCACTT	430
	R: GTACGGCGTTTCGATGAACC
katG	F: AATCGATGGGCTTCAAGACG	500
	R: CTCGTAGCCGTACAGGATCTCG
inhA	F: CCTCGCTGCCCAGAAAGGGA	248
	R: ATCCCCCGGTTTCCTCCGGT

检测技术	TruArray芯片			敏感度(%) (95%CI值)	特异度(%) (95%CI值)
检测技术	阳性(例)	阴性(例)	合计(例)	敏感度(%) (95%CI值)	特异度(%) (95%CI值)
MGIT 960液体培养				97.9(93.9~100.0)	61.4(51.9~70.9)
阳性	47	1	48
阴性	39	62	101
合计	86	63	149
GeneXpert				97.5(94.1~100.0)	88.4(80.9~96.0)
阳性	78	2	80
阴性	8	61	69
合计	86	69	149

检测技术	TruArray芯片			敏感度(%) (95%CI值)	特异度(%) (95%CI值)
检测技术	耐药(例)	敏感(例)	合计(例)	敏感度(%) (95%CI值)	特异度(%) (95%CI值)
MGIT 960药敏试验				91.7(76.0~100.0)	96.8(90.6~100.0)
耐药	11	1	12
敏感	1	30	31
合计	12	31	43
GeneXpert				85.0(69.4~100.0)	97.9(93.9~100.0)
耐药	17	3	20
敏感	1	47	48
合计	18	50	68
耐药基因测序				92.3(77.8~100.0)	100.0(83.3~99.9)
耐药	12	1	13
敏感	0	30	30
合计	12	31	43

检测技术	TruArray芯片			敏感度(%) (95%CI值)	特异度(%) (95%CI值)
检测技术	耐药(例)	敏感(例)	合计(例)	敏感度(%) (95%CI值)	特异度(%) (95%CI值)
MGIT960药敏试验				78.6(57.1~100.0)	93.8(85.4~100.0)
耐药	11	3	14
敏感	2	30	32
合计	13	33	46
耐药基因测序				100.0(58.7~99.8)	94.3(86.6~100.0)
耐药	11	0	11
敏感	2	33	35
合计	13	33	46

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