县级实验室结核病检测方法的诊断效果分析: 一项基于真实世界数据的回顾性研究

doi:10.19982/j.issn.1000-6621.20240409

中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (2): 181-188.doi: 10.19982/j.issn.1000-6621.20240409

县级实验室结核病检测方法的诊断效果分析: 一项基于真实世界数据的回顾性研究

邱勇¹, 权卓², 屈榕¹, 田发君¹, 李蒙², 王更生¹, 王娅¹, 郭明成¹, 高谦²()

¹四川省广安市武胜县疾病预防控制中心结核病防治科,广安 638401
²复旦大学上海市重大传染病和生物安全研究院,基础医学院教育部、卫健委、医科院医学分子病毒学重点实验室,上海 200032

收稿日期:2024-09-14 出版日期:2025-02-10 发布日期:2025-02-08
通信作者: 高谦,Email: qiangao@fudan.edu.cn
基金资助:
上海市科技重大专项(ZD2021CY001);国家自然科学基金(82272376);国家自然科学基金(32470186)

Evaluation of different tuberculosis diagnostic tools for detecting patients in a primary-level clinic in rural China: a real-world retrospective study

Qiu Yong¹, Quan Zhuo², Qu Rong¹, Tian Fajun¹, Li Meng², Wang Gengsheng¹, Wang Ya¹, Guo Mingcheng¹, Gao Qian²()

¹Department of Tuberculosis Control, Wusheng County Center for Disease Control and Prevention, Guang’an 638401, China
²Shanghai Institute of Infectious Disease and Biosecurity, Key Laboratory of Medical Molecular Virology (MOE/NHC/CAMS), School of Basic Medical Science, Fudan University, Shanghai 200032, China

Received:2024-09-14 Online:2025-02-10 Published:2025-02-08
Contact: Gao Qian, Email: qiangao@fudan.edu.cn
Supported by:
Shanghai Municipal Science and Technology Major Project(ZD2021CY001);National Natural Science Foundation of China(82272376);National Natural Science Foundation of China(32470186)

摘要/Abstract

摘要：

目的: 利用县级实验室常规结核病检测数据,评估固体培养、GeneXpert MTB/RIF(简称“Xpert”)和GeneXpert MTB/RIF Ultra(简称“Xpert Ultra”)在基层定点医疗机构诊断结核病患者的实际效果。 方法: 纳入2018年7月至2024年1月期间,就诊于武胜县疾病预防控制中心结核病防治门诊的疑似肺结核患者及其首诊痰标本。就诊患者被要求采集3份痰标本开展涂片、培养和分子生物学检测,用于结核病诊断。以液体培养结果为标准,计算固体培养、Xpert和Xpert Ultra诊断结核病的敏感度、特异度、阳性预测值和阴性预测值;同时基于涂片结果进行亚组分析,计算3种检测方法分别诊断涂阳和涂阴患者的敏感度。 结果: 共2769例疑似肺结核患者纳入研究,其中24.56%(680/2769)为女性。涂片、固体培养、液体培养、Xpert和Xpert Ultra的阳性率分别为10.36%(286/2761)、23.66%(362/1530)、29.31%(730/2491)、28.06%(275/980)和35.33%(254/719)。以液体培养结果为标准,固体培养、Xpert和Xpert Ultra的敏感度分别为84.55%(80.53%~88.03%)、91.19%(86.72%~94.54%)和96.20%(92.32%~98.46%),特异度分别为99.00%(98.17%~99.52%)、92.62%(90.27%~94.54%)和86.65%(83.05%~89.73%)。在涂阴但液体培养阳性的患者中,固体培养、Xpert和Xpert Ultra的敏感度分别为76.08%(69.71%~81.69%)、83.74%(76.01%~89.78%)和94.17%(88.35%~97.62%)。Xpert或Xpert Ultra阳性但培养阴性的患者中,49.51%(51/103)的患者就诊前2周内服用过抗结核药物或有结核病病史。Xpert Ultra检测为痕量(Trace)的患者中,74.19%(23/31)可判断为活动性结核病。 结论: 液体培养和分子诊断工具在真实基层结核病诊断中具有较高敏感度,特别是Xpert Ultra,可以有效实现对当地低菌量患者的快速诊断。加快液体培养和Xpert Ultra在基层实验室的普及可以显著提升患者检出率,并有助于实现结核病的早期诊断和治疗。

关键词: 结核, 实验室, 诊断, 敏感性与特异性, 回顾性研究

Abstract:

Objective: To evaluate the real-world performance of solid culture, GeneXpert MTB/RIF (Xpert), and Xpert MTB/RIF Ultra (Xpert Ultra) in diagnosing tuberculosis (TB) patients at primary-level health facilities. Methods: Suspected pulmonary TB patients who presented to the Wusheng County Center for Disease Control and Prevention (Wusheng CDC) from July 2018 to January 2024 were included in this study. Initial sputum samples were collected and subjected to smear microscopy, culture, Xpert and Xpert Ultra tests. The sensitivity, specificity, positive predictive value and negative predictive value of solid culture, Xpert and Xpert Ultra were calculated using liquid culture as the reference. Additionally, sensitivity and 95% confidence interval (CI) for diagnosing smear-negative patients were assessed for each method. Results: A total of 2769 individuals participated, with 24.56% (680/2769) being female. Detection rates for smear, solid culture, liquid culture, Xpert, and Xpert Ultra were 10.36% (286/2761), 23.66% (362/1530), 29.31% (730/2491), 28.06% (275/980), and 35.33% (254/719), respectively. Sensitivities of solid culture, Xpert and Xpert Ultra were 84.55% (80.53%-88.03%), 91.19% (86.72%-94.54%) and 96.20% (92.32%-98.46%), while specificities were 99.00% (98.17%-99.52%), 92.62% (90.27%-94.54%) and 86.65% (83.05%-89.73%), respectively. Among the smear-negative culture-positive patients, the sensitivities of solid culture, Xpert and Xpert Ultra were 76.08% (69.71%-81.69%), 83.74% (76.01%-89.78%) and 94.17% (88.35%-97.62%). Among culture-negative Xpert or Xpert Ultra-positive patients, 49.51% (51/103) were taking anti-TB drugs in the previous two weeks or had a history of TB. Of the samples that Xpert Ultra classified as trace, 74.19% (23/31) were true-positives. Conclusion: Liquid culture and rapid molecular tests demonstrate high sensitivity for diagnosing TB in primary-level clinics. Xpert Ultra, in particular, is effective for rapid diagnosis of paucibacillary patients. Expanding the use of liquid culture and Xpert Ultra at primary-level clinics can significantly improve detection rates and contribute to the early diagnosis and treatment of patients.

Key words: Tuberculosis, Laboratories, Diagnosis, Sensitivity and specificity, Retrospective studies

中图分类号:

R521

邱勇, 权卓, 屈榕, 田发君, 李蒙, 王更生, 王娅, 郭明成, 高谦. 县级实验室结核病检测方法的诊断效果分析: 一项基于真实世界数据的回顾性研究[J]. 中国防痨杂志, 2025, 47(2): 181-188. doi: 10.19982/j.issn.1000-6621.20240409

Qiu Yong, Quan Zhuo, Qu Rong, Tian Fajun, Li Meng, Wang Gengsheng, Wang Ya, Guo Mingcheng, Gao Qian. Evaluation of different tuberculosis diagnostic tools for detecting patients in a primary-level clinic in rural China: a real-world retrospective study[J]. Chinese Journal of Antituberculosis, 2025, 47(2): 181-188. doi: 10.19982/j.issn.1000-6621.20240409

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方法	敏感度	敏感度:涂阳培阳	敏感度:涂阴培阳	特异度	阳性预测值	阴性预测值
固体培养 (1380例)	84.55 (80.53~88.03; 323/382)	94.80 (90.35~97.59; 164/173)	76.08 (69.71~81.69; 159/209)	99.00 (98.17~99.52; 988/998)	97.00 (94.55~98.55; 323/333)	94.36 (92.79~95.68; 988/1047)
Xpert (850例)	91.19 (86.72~94.54; 207/227)	100.00 (96.52~100.00; 104/104)	83.74 (76.01~89.78; 103/123)	92.62 (90.27~94.54; 577/623)	81.82 (76.50~86.37; 207/253)	96.65 (94.87~97.94; 577/597
Xpert Ultra (611例)	96.20 (92.32~98.46; 177/184)	100.0 (94.40~100.00; 64/64)	94.17 (88.35~97.62; 113/120)	86.65 (83.05~89.73; 370/427)	75.64 (69.62~81.00; 177/234)	98.14 (96.21~99.25; 370/377)

县级实验室结核病检测方法的诊断效果分析: 一项基于真实世界数据的回顾性研究

Evaluation of different tuberculosis diagnostic tools for detecting patients in a primary-level clinic in rural China: a real-world retrospective study

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基本情况	例数	率(%)	基本情况	例数	率(%)
性别^a			Xpert检测(980例)
女性	680	24.56	阳性	275	28.06
男性	2089	75.44	高	60	21.82
涂片(2761例)			中	77	28.00
阳性	286	10.36	低	68	24.73
++++	34	11.89	极低	70	25.45
+++	77	26.92	Xpert Ultra检测(719例)
++	81	28.32	阳性	254	35.33
+	65	22.73	高	62	24.41
细菌数/300视野	29	10.14	中	50	19.69
液体培养(2491例)			低	74	29.13
阳性	730	29.31	极低	32	12.60
固体培养(1530例)			Trace	36	14.17
阳性	362	23.66

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