环介导等温扩增法对无痰或痰涂阴肺结核的诊断价值

doi:10.19983/j.issn.2096-8493.20230001

结核与肺部疾病杂志 ›› 2023, Vol. 4 ›› Issue (1): 66-71.doi: 10.19983/j.issn.2096-8493.20230001

环介导等温扩增法对无痰或痰涂阴肺结核的诊断价值

曾芳¹, 朱小霞², 龚蕊², 刘传红³, 石德俊⁴, 赵玲², 杨松⁵()

¹重庆市巫山县中医院专家门诊,重庆 404700
²重庆市巫山县人民医院感染科,重庆 404700
³重庆市巫山县人民医院呼吸内科,重庆 404700
⁴重庆市巫山县人民医院检验科,重庆 404700
⁵重庆市公共卫生医疗救治中心综合内科,重庆 400030

收稿日期:2022-11-04 出版日期:2023-02-20 发布日期:2023-02-09
通信作者: 杨松 E-mail:yangsong5@aliyun.com
基金资助:
重庆市科卫联合医学科研项目(2020FYYX243)

Diagnostic value of loop-mediated isothermal amplification method in non sputum or smear negative pulmonary tuberculosis

Zeng Fang¹, Zhu Xiaoxia², Gong Rui², Liu Chuanhong³, Shi Dejun⁴, Zhao Ling², Yang Song⁵()

¹Specialist Clinic, Wushan County Hospital of TCM, Chongqing 404700, China
²Department of Infectious Disease, Wushan County People’s Hospital of Chongqing, Chongqing 404700, China
³Department of Respiratory Medicine, Wushan County People’s Hospital of Chongqing, Chongqing 404700, China
⁴Department of Clinical Laboratory, Wushan County People’s Hospital of Chongqing, Chongqing 404700, China
⁵Comprehensive Internal Medicine, Chongqing Public Health Medical Center, Chongqing 400030, China

Received:2022-11-04 Online:2023-02-20 Published:2023-02-09
Contact: Yang Song E-mail:yangsong5@aliyun.com
Supported by:
Chongqing Science and Health Joint Medical Research(2020FYYX243)

摘要/Abstract

摘要：

目的: 探讨环介导等温扩增法(loop-mediated isothermal amplification, LAMP)检测支气管肺泡灌洗液对无痰或涂阴肺结核的诊断价值。方法: 采用前瞻性研究方法,纳入2021年4月至2022年4月重庆市巫山县人民医院收治且符合入组标准的无痰/痰涂片阴性疑似肺结核患者作为研究对象,均在支气管镜下刷片行荧光染色显微镜检查(简称“涂片镜检”),并取支气管肺泡灌洗液行LAMP和GeneXpert MTB/RIF(简称“Xpert”)检测结核分枝杆菌复合群DNA。以最终临床诊断为参照标准,分析3种方法在所有疑似肺结核患者中的检测效能。结果: 研究共纳入232例患者,以最终临床诊断将患者分为涂阴/无痰肺结核患者(139例)和非结核肺病患者(93例)。LAMP、Xpert和涂片镜检对232例疑似肺结核患者的检测阳性率分别为43.53%(101/232)、43.97%(102/232)和8.19%(19/232)。以最终临床诊断为参照标准,LAMP、Xpert和涂片镜检对无痰/涂阴肺结核的检测敏感度分别为71.94%(100/139)、72.66%(101/139)和13.67%(19/139),特异度分别为 98.92%(92/93)、98.92%(92/93)和100.00%(93/93),诊断一致率分别为82.76%(192/232)、83.19%(193/232)和48.28%(112/232),约登指数分别为0.709、0.716和0.137。结论: LAMP对无痰/涂阴肺结核患者支气管肺泡灌洗液的检测效能与Xpert基本一致,可明显提高早期诊断率;且LAMP操作简便、收费价格低廉,更适用于基层医疗机构推广应用。

关键词: 结核,肺, 支气管肺泡灌洗液, 核酸扩增技术, 评价研究

Abstract:

Objective: To explore the diagnostic value of loop-mediated isothermal amplification (LAMP) in detecting bronchoalveolar lavage fluid (BALF) in non sputum or smear negative pulmonary tuberculosis. Methods: The prospective study method was adopted, with the subjects being the sputum free or smear negative suspected pulmonary tuberculosis patients who were admitted to Wushan County People’s Hospital of Chongqing from April 2021 to April 2022 and met the inclusion criteria; they all brushed under bronchoscope for fluorescent staining microscopy (referred to as “smear”), and took BALF for LAMP and GeneXpert MTB/RIF (referred to as “Xpert”) to detect Mycobacterium tuberculosis complex DNA. With the final clinical diagnosis as the reference standard, the detection efficiency of the three methods was analyzed. Results: A total of 232 patients were included in the study. The patients were divided into smear negative/sputum free pulmonary tuberculosis patients (139 cases) and non tuberculosis pulmonary disease patients (93 cases) according to the final clinical diagnosis. The positive rates of LAMP, Xpert and smear in 232 patients with suspected pulmonary tuberculosis were 43.53% (101/232), 43.97% (102/232) and 8.19% (19/232), respectively. Taking the final clinical diagnosis as the reference standard, the detection sensitivity of LAMP, Xpert and smear for sputum free or smear negative pulmonary tuberculosis were 71.94% (100/139), 72.66% (101/139) and 13.67% (19/139) respectively; the specificity were 98.92% (92/93), 98.92% (92/93) and 100.00% (93/93) respectively; the diagnostic coincidence rates were 82.76% (192/232), 83.19% (193/232) and 48.28% (112/232); the Yoden index were 0.709, 0.716 and 0.137, respectively. Conclusion: The detection efficiency of LAMP for BALF in patients with sputum free or smear negative pulmonary tuberculosis is basically consistent with that of Xpert, significantly improving the early diagnosis rate; in addition, LAMP is easy to operate and cheap, which is more suitable for the promotion and application of grass-roots medical institutions.

Key words: Tuberculosis, pulmonary, Bronchoalveolar lavage fluid, Nucleic acid amplification techniques, Evaluation studies

中图分类号:

R521

曾芳, 朱小霞, 龚蕊, 刘传红, 石德俊, 赵玲, 杨松. 环介导等温扩增法对无痰或痰涂阴肺结核的诊断价值[J]. 结核与肺部疾病杂志, 2023, 4(1): 66-71. doi: 10.19983/j.issn.2096-8493.20230001

Zeng Fang, Zhu Xiaoxia, Gong Rui, Liu Chuanhong, Shi Dejun, Zhao Ling, Yang Song. Diagnostic value of loop-mediated isothermal amplification method in non sputum or smear negative pulmonary tuberculosis[J]. Journal of Tuberculosis and Lung Disease, 2023, 4(1): 66-71. doi: 10.19983/j.issn.2096-8493.20230001

图/表 2

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LAMP检测	Xpert检测		合计(例)	χ²值	P值
LAMP检测	阳性(例)	阴性(例)	合计(例)	χ²值	P值
阳性	94	6	100	0.077	0.782
阴性	7	32	39
合计	101	38	139

环介导等温扩增法对无痰或痰涂阴肺结核的诊断价值

Diagnostic value of loop-mediated isothermal amplification method in non sputum or smear negative pulmonary tuberculosis

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参考文献 24

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检测方法	临床诊断(例)		敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	一致率 (%)	约登指数
检测方法	肺结核	非活动性结核性肺病	敏感度 (%)	特异度 (%)	阳性预测值 (%)	阴性预测值 (%)	一致率 (%)	约登指数
LAMP			71.94	98.92	99.01	70.23	82.76	0.709
阳性	100	1
阴性	39	92
Xpert			72.66	98.92	99.02	70.23	83.19	0.716
阳性	101	1
阴性	39	92
涂片镜检			13.67	100.00	100.00	43.66	48.28	0.137
阳性	19	0
阴性	120	93

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