Early health technology assessment of tongue swab for non-sputum based pulmonary tuberculosis diagnosis in Thailand

IF 5 Q1 HEALTH CARE SCIENCES & SERVICES

The Lancet regional health. Southeast Asia Pub Date : 2025-02-01 DOI:10.1016/j.lansea.2025.100533

Langming Mou , Teerawat Wiwatpanit , Apiwat Piriyapol , Puwadol Chawengkul , Janjira Thaipadungpanit , Puttarin Kulchaitanaroaj , Yot Teerawattananon , Yi Wang

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引用次数: 0

Abstract

Background

Sputum-based diagnostic methods for pulmonary tuberculosis (PTB) are challenging for patients who cannot produce sputum. Non-sputum-based approaches, such as tongue swab (TS), can address this gap. This study conducts an early Health Technology Assessment (HTA) of TS for PTB diagnosis in Thailand.

Methods

We conducted a landscape review, stakeholder consultation, early health economic modeling, and established a Target Product Profile (TPP). The landscape review included a comprehensive literature analysis to identify gaps and unmet needs in PTB diagnosis in Thailand. Stakeholder consultations gathered insights from TB experts to validate the information. An early health economic model evaluated the cost-effectiveness of two innovative strategies: tongue swab with Loop-Mediated Isothermal Amplification (LAMP) and tongue swab with real-time polymerase chain reaction (RTPCR). The TPP outlines three target levels to guide innovators in designing effective clinical studies.

Findings

The landscape review identified the clinical workflow and reimbursement process of all PTB diagnostic tests in Thailand. The gap of tuberculosis management was around diagnosis and treatment. Stakeholders indicated that PTB detection remains inefficient due to issues such as low-test accuracy, costs, delays, drug-resistance testing, and the need for specialized laboratory techniques and personnel. TS RTPCR is the best-performing strategy, outperforming other strategies for the targeted population from the modelling analysis.

Interpretation

TS may serve as a viable alternative worth further exploration and development. An ongoing collaboration between early HTA researchers and innovators has identified valuable information for innovation development.

Funding

This work was supported by Thailand Science Research and Innovation (TSRI), Thailand, Grant Number FFB670043/0401 and Wellcome Trust grant, Grant Number 223800/Z/21/Z.

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泰国舌拭子对非痰基础肺结核诊断的早期卫生技术评估

基于痰液的肺结核（PTB）诊断方法对不能产痰的患者具有挑战性。非基于痰液的方法，如舌拭子（TS），可以弥补这一差距。本研究对泰国肺结核诊断的TS进行早期卫生技术评估（HTA）。方法我们进行了景观回顾，利益相关者咨询，早期健康经济模型，并建立了目标产品概况（TPP）。该综述包括一项全面的文献分析，以确定泰国肺结核诊断方面的差距和未满足的需求。利益攸关方磋商收集了结核病专家的见解，以验证这些信息。一个早期卫生经济模型评估了两种创新策略的成本效益：环介导等温扩增（LAMP）舌拭子和实时聚合酶链反应（RTPCR）舌拭子。TPP概述了三个目标水平，以指导创新者设计有效的临床研究。研究结果：概况综述确定了泰国所有肺结核诊断检测的临床工作流程和报销流程。结核病管理的差距主要集中在诊断和治疗方面。利益攸关方指出，由于检测准确性低、成本高、延误、耐药检测以及需要专门的实验室技术和人员等问题，肺结核检测仍然效率低下。TS RTPCR是表现最好的策略，从建模分析中优于目标人群的其他策略。解译可以作为一种可行的替代方法，值得进一步探索和开发。早期HTA研究人员和创新者之间正在进行的合作已经确定了创新发展的宝贵信息。本研究由泰国科学研究与创新（TSRI）资助，资助号为FFB670043/0401；惠康信托基金资助，资助号为223800/Z/21/Z。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

The Lancet regional health. Southeast Asia

CiteScore

2.20

自引率

0.00%

发文量