Noninvasive Detection of Tuberculosis by Oral Swab Analysis
Noninvasive Detection of Tuberculosis by Oral Swab Analysis
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DOI：
10.1128/jcm.01847-18
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发表时间：
2019-03-01
影响因子：
9.4
通讯作者：
Cangelosi, Gerard A.
中科院分区：
文献类型：
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作者：
Luabeya, Angelique K.;Wood, Rachel C.;Cangelosi, Gerard A.
结核病(TB)的诊断测试通常需要收集痰，这是一种来自人类呼吸道的粘性物质。收集痰可能是困难和危险的，在实验室处理也是有挑战性的。口腔拭子已被建议作为非侵入性且易于收集的替代样本类型。本研究评估口腔拭子分析(OSA)诊断结核病的生物学可行性。检测来自南非成人受试者的拭子，包括经GeneXpert(GeneXpert)确诊的肺结核患者(n=138)，痰GeneXpert阴性但培养阳性的结核病患者(n=10)，患病的非结核病患者(n=37)，以及Quantiferon阴性的对照组(n=34)。用针对IS6110的手动非套式定量聚合酶链式反应(QPCR)对拭子进行分析。比较了两个棉签品牌和三个口腔内的位置。擦拭舌头比擦拭脸颊或牙床产生的信号要强得多。植绒棉签比更昂贵的纸签效果更好。在一项分两个阶段进行的研究中，舌拭子(每个受试者两个)对GeneXpert的联合敏感性为92.8%。相对于所有实验室诊断的结核病，GeneXpert(每个受试者1个样本)和OSA(每个受试者2个样本)的诊断率分别为49/59(83.1%)。OSA的特异度为91.5%。对“空气拭子”的分析表明，大多数假阳性结果是由于人工PCRS的污染造成的。随着适当的自动化方法的发展，口腔拭子可以促进临床环境和患者群体中的结核病诊断，这些环境和患者受到收集痰的物理或后勤挑战的限制。
Diagnostic tests for tuberculosis (TB) usually require collection of sputum, a viscous material derived from human airways. Sputum can be difficult and hazardous to collect and challenging to process in the laboratory. Oral swabs have been proposed as alternative sample types that are noninvasive and easy to collect. This study evaluated the biological feasibility of oral swab analysis (OSA) for the diagnosis of TB. Swabs were tested from South African adult subjects, including sputum GeneXpert MTB/RIF (GeneXpert)-confirmed TB patients (n = 138), sputum GeneXpert-negative but culture-positive TB patients (n = 10), ill non-TB patients (n = 37), and QuantiFERON-negative controls (n = 34). Swabs were analyzed by using a manual, nonnested quantitative PCR (qPCR) targeting IS6110. Two swab brands and three sites within the oral cavity were compared. Tongue swabbing yielded significantly stronger signals than cheek or gum swabbing. A flocked swab performed better than a more expensive paper swab. In a two-phase study, tongue swabs (two per subject) exhibited a combined sensitivity of 92.8% relative to sputum GeneXpert. Relative to all laboratory-diagnosed TB, the diagnostic yields of sputum GeneXpert (1 sample per subject) and OSA (2 samples per subject) were identical at 49/59 (83.1%) each. The specificity of the OSA was 91.5%. An analysis of "air swabs" suggested that most false-positive results were due to contamination of manual PCRs. With the development of appropriate automated methods, oral swabs could facilitate TB diagnosis in clinical settings and patient populations that are limited by the physical or logistical challenges of sputum collection.