Analysis of the effect of GeneXpert MTB/RIF technology on early detection of bacteriologically confirmed and drug-resistant pulmonary tuberculosis in general hospitals

doi:10.19982/j.issn.1000-6621.20230313

Abstract

Abstract:

Objective: To understand the current situation of GeneXpert MTB/RIF (GeneXpert) technology in the diagnosis of bacteriologically confirmed pulmonary tuberculosis and drug-resistant pulmonary tuberculosis in general hospitals, so as to better play the role of general hospitals in the detection of pulmonary tuberculosis. Methods: A retrospective cohort study was conducted with pulmonary tuberculosis patients that from 8 tertiary general hospitals equipped with GeneXpert as the study group and those from 3 tertiary general hospitals not equipped with GeneXpert as the control group. The proportion of bacteriologically confirmed patients, the proportion of rifampicin-resistant patients, the diagnosis time of pulmonary tuberculosis patients and the diagnosis time of rifampicin-resistant patients were compared and analyzed between the two groups. Results: A total of 370 patients who were tested by GeneXpert in the study group and 342 patients who were not tested by GeneXpert in the control group were enrolled in the study. The proportion of bacteriologically confirmed patients in the study group (88.9%, 329/370) was higher than that in the control group (67.0%, 229/342; χ²=50.560, P<0.001). Among the patients with bacteriologically confirmed, the proportion of first diagnosis in the study group (96.4%, 317/329) was higher than that in the control group (75.1%, 172/229; χ²=56.228, P<0.001). The diagnosis time of pulmonary tuberculosis in the study group (1 (1,5) d) was shorter than that in the control group (4 (1,11) d; nonparametric test, P<0.001). The study group found that the proportion of patients with rifampicin resistance was 80.0% (8/10), while the proportion found in the control group was 0 (0/6; Fisher’s exact test, P=0.007). The diagnosis time of rifampicin resistance in the study group (1 (1,4) d) was significantly shorter than that in the control group (20 (11,29) d; nonparametric test, P=0.005). Among the patients in the study group who underwent both GeneXpert and sputum smear testing, the proportion of MTB detected by GeneXpert (82.0%, 242/295) was higher than that detected by sputum smear (33.6%, 99/295; χ²=142.092, P<0.001); when GeneXpert and sputum culture were tested simultaneously, the proportion of MTB detected by GeneXpert (86.3%, 107/124) was higher than that of sputum culture (63.7%, 79/124; χ²=16.860, P<0.001). Conclusion: GeneXpert technology is helpful for the early diagnosis of bacteriologically confirmed pulmonary tuberculosis and drug-resistant pulmonary tuberculosis in general hospitals. It is suggested that general hospitals should routinely carry out GeneXpert test and incorporate it into the medical insurance reimbursement catalogue to improve its efficiency.

Key words: Tuberculosis, pulmonary, Drug resistance, Molecular diagnostic techniques, Comparative study

CLC Number:

R521

Ruan Yunzhou, Zhang Hongwei, Li Yuehua, Ma Yingzi, Cheng Shiming, Fan Haiying, Li Renzhong, Zhao Yanlin. Analysis of the effect of GeneXpert MTB/RIF technology on early detection of bacteriologically confirmed and drug-resistant pulmonary tuberculosis in general hospitals[J]. Chinese Journal of Antituberculosis, 2023, 45(11): 1072-1077. doi: 10.19982/j.issn.1000-6621.20230313

Figures/Tables 3

References 11

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特征	研究组(370例)	对照组(342例)	统计检验值	P值
性别[例(构成比,%)]			χ²=0.458	0.499
男性	218(58.9)	210(61.4)
女性	152(41.1)	132(38.6)
年龄组[例(构成比,%)]			χ²=1.973	0.373
15~34岁	84(22.7)	65(19.0)
35~54岁	85(23.0)	90(26.3)
≥55岁	201(54.3)	187(54.7)
患者来源[例(构成比,%)]			χ²=46.547	<0.001
门诊	116(31.4)	194(56.7)
住院	254(68.6)	148(43.3)
住院天数[d,M(Q₁,Q₃)]	5(3,7)	7(4,9)	-^a	<0.001^a

分类	研究组(370例)	对照组(342例)	统计检验值	P值
病原学检查结果[例(构成比,%)]			χ²=50.560	<0.001
病原学阳性	329(88.9)	229(67.0)
综合医院首诊确诊	317(96.4)	172(75.1)	χ²=56.228	<0.001
转诊到定点医院确诊	12(3.6)	57(24.9)
病原学阴性	41(11.1)	113(33.0)
病例分类[例(构成比,%)]			χ²=163.653	<0.001
疑似肺结核	1(0.3)	83(24.3)
临床诊断肺结核	44(11.9)	87(25.4)
确诊肺结核	325(87.8)	172(50.3)
肺结核诊断时间[d,M(Q₁,Q₃)]	1(1,5)	4(1,11)	-^a	<0.001^a

分类	研究组	对照组	统计检验值	P值
首诊发现的病原学阳性患者[例(构成比,%)]	317(100.0)	172(100.0)	χ²=592.802	<0.001
本院直接开展利福平耐药性检测	314(99.1)	0(0.0)
转到定点医院开展利福平耐药性检测	2(0.6)	105(61.0)
未开展利福平耐药性检测	1(0.3)	67(39.0)
利福平耐药患者[例(构成比,%)]	10(100.0)	6(6/6)	-^a	0.007^a
本院发现的利福平耐药	8(80.0)	0(0/6)
转到定点医院发现的利福平耐药	2(20.0)	6(6/6)
利福平耐药诊断时间[d,M(Q₁,Q₃)]	1(1,4)	20(11,29)	-^b	0.005^b

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