AveloMask, a novel breath aerosol collection kit for airborne Mycobacterium tuberculosis: a proof-of-principle assessment.

IF 5.4 2区 医学 Q1 MICROBIOLOGY
Journal of Clinical Microbiology Pub Date : 2025-09-10 Epub Date: 2025-08-21 DOI:10.1128/jcm.00546-25
Patricia Risch, Tobias Broger, Zandile Booi, Katie Tiseo, Harshitha Santhosh Kumar, Jamie van Schalkwyk, Theresa Heinrich, Reto Willi, Stefan M Botha, Peter Sander, Adithya Cattamanchi, Stephan Hubold, Claudia M Denkinger, Grant Theron, Christina Fialová, Christian Adlhart, Rouxjeane Venter
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引用次数: 0

Abstract

Tuberculosis (TB) remains the world's deadliest infectious disease, with many active cases missed due to challenges in sputum collection. Exhaled breath aerosols (XBA), a major route of Mycobacterium tuberculosis (MTB) transmission, offer a promising non-invasive alternative. This study evaluated the diagnostic accuracy and feasibility of the AveloMask-a novel point-of-care breath aerosol collection kit-for detecting active pulmonary TB using quantitative PCR (qPCR). In a pilot diagnostic accuracy study, 61 symptomatic, adult outpatients in Cape Town, South Africa, wore the mask for 45 min, coughing deeply at the start and end. XBAs were collected on integrated fiber filters transferred into stabilizing buffer via a simple push step and biobanked. XBA's were batch-analyzed by qPCR targeting the MTB-specific IS6110 sequence. Diagnostic accuracy was assessed against sputum Xpert MTB/RIF Ultra (SXRS) and a composite microbiological reference standard (MRS), including culture. Of the 58 evaluable participants, 59% (34/58) had confirmed TB. Compared with SXRS, mask qPCR showed 71.0% (95% confidence interval [CI]: 53.4%-83.9%) sensitivity and 92.3% (95% CI:75.9%-97.9%) specificity. Against MRS, sensitivity was 64.7% (95% CI: 47.9%-78.5%) and specificity 91.7% (95% CI: 74.2%-97.7%). Sensitivity increased with bacterial load, reaching 100% in sputum with high MTB concentrations. MTB IS6110 copy numbers in XBAs were low overall (175 copies [4-2,147]), likely due to insufficient DNA recovery or low aerosol bacilli. The mask sampling was well-tolerated by users. The AveloMask Kit shows promising diagnostic accuracy for TB and is feasible for point-of-care use. Further optimization and larger validation studies are warranted.IMPORTANCETuberculosis (TB) remains the world's deadliest infectious disease, yet diagnosis still relies heavily on sputum, which many patients struggle to produce. This study introduces the AveloMask Kit, a user-friendly, non-invasive face mask that captures exhaled aerosols and transfers them into a buffer tube for molecular detection of respiratory tract infections. In a clinical proof-of-principle study, AveloMask detected TB with promising accuracy and demonstrated feasibility in outpatient settings. By offering a non-invasive alternative to sputum, the AveloMask Kit addresses a critical diagnostic gap and could expand access to TB testing, particularly in resource-limited or primary care settings. Its simplicity enables use by minimally trained staff, and its stabilizing buffer allows ambient-temperature transport and biobanking, supporting broader case finding, safer sample collection, and future aerobiology research.

AveloMask,一种用于空气传播结核分枝杆菌的新型呼吸气溶胶收集试剂盒:原理验证评估。
结核病(TB)仍然是世界上最致命的传染病,由于痰收集方面的挑战,许多活动性病例未被发现。呼气气溶胶(XBA)是结核分枝杆菌(MTB)传播的主要途径,提供了一种有希望的非侵入性替代方法。本研究评估了avelomask(一种新型的即时呼吸气溶胶收集试剂盒)诊断活动性肺结核的准确性和可行性,该试剂盒使用定量PCR (qPCR)检测活动性肺结核。在一项诊断准确性的试点研究中,南非开普敦的61名有症状的成年门诊患者戴上口罩45分钟,开始和结束时都剧烈咳嗽。xba收集在集成纤维过滤器上,通过简单的推动步骤转移到稳定缓冲液中并进行生物银行。针对mtb特异性IS6110序列,采用qPCR对XBA进行批量分析。采用痰液Xpert MTB/RIF Ultra (SXRS)和复合微生物参考标准(MRS)(包括培养)评估诊断准确性。在58名可评估的参与者中,59%(34/58)确诊结核病。与SXRS相比,掩膜qPCR的敏感性为71.0%(95%可信区间[CI]: 53.4% ~ 83.9%),特异性为92.3% (95% CI:75.9% ~ 97.9%)。对MRS的敏感性为64.7% (95% CI: 47.9%-78.5%),特异性为91.7% (95% CI: 74.2%-97.7%)。敏感性随细菌负荷增加而增加,在结核分枝杆菌浓度高的痰液中达到100%。xba中的MTB IS6110拷贝数总体较低(175个拷贝[4-2,147]),可能是由于DNA恢复不足或气溶胶杆菌数量较少。用户对口罩采样的耐受性良好。AveloMask试剂盒显示出对结核病有希望的诊断准确性,并且在护理点使用是可行的。进一步的优化和更大的验证研究是必要的。结核病(TB)仍然是世界上最致命的传染病,但诊断仍然严重依赖于痰,许多患者难以产生痰。这项研究介绍了AveloMask试剂盒,这是一种用户友好的非侵入性面罩,可捕获呼出的气溶胶并将其转移到缓冲管中,用于呼吸道感染的分子检测。在一项临床原理验证研究中,AveloMask检测结核病的准确性很高,并且在门诊环境中证明了其可行性。通过提供一种非侵入性的痰液替代品,AveloMask试剂盒解决了一个关键的诊断缺口,并可以扩大结核病检测的可及性,特别是在资源有限或初级保健环境中。它的简单性使最少受过培训的工作人员可以使用,其稳定的缓冲液允许常温运输和生物库,支持更广泛的病例发现,更安全的样本收集和未来的空气生物学研究。
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
Journal of Clinical Microbiology
Journal of Clinical Microbiology 医学-微生物学
CiteScore
17.10
自引率
4.30%
发文量
347
审稿时长
3 months
期刊介绍: The Journal of Clinical Microbiology® disseminates the latest research concerning the laboratory diagnosis of human and animal infections, along with the laboratory's role in epidemiology and the management of infectious diseases.
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