PDF(Pubmed)
Abstract：
BACKGROUND: The lack of accurate and efficient diagnostic devices for extensively drug-resistant tuberculosis (XDR-TB) makes it a severe threat to global public health. A prospective clinical study in an intended-use cohort was designed to evaluate the Akonni Biosystems XDR-TB TruArray and lateral flow cell (XDR-LFC) to address this gap in tuberculosis diagnostics.
OBJECTIVE: This paper presents the protocol for a study that aims to document the conceptualization and design of this evaluation method for early dissemination while data collection and analysis are ongoing.
METHODS: The clinical study was conducted in three phases. The first phase was to observe changes in bacterial load and culture positivity in patient sputa over time and better understand the diversity of prospective clinical samples. The second phase was to prospectively collect clinical samples for sensitivity and specificity testing of the Akonni Biosystems XDR-LFC device. Lastly, the third phase was to explore the anti-TB drug concentrations in serum throughout the drug-resistant tuberculosis treatment.
RESULTS: The methodology described includes the study design, laboratory sample handling, data collection, and the protection elements of human subjects of this clinical study to evaluate a potential new XDR-TB diagnostic device. A total of 664 participants were enrolled across the three phases. The implemented complex systems facilitated a thorough clinical data collection for an objective evaluation of the device. The study is closed to recruitment. The follow-up data collection and analysis are in progress.
CONCLUSIONS: This paper outlined a prospective cohort study protocol to evaluate a rapid XDR-TB detection device, which may be informative for other researchers with similar goals.
UNASSIGNED: DERR1-10.2196/26748.
OBJECTIVE: This paper presents the protocol for a study that aims to document the conceptualization and design of this evaluation method for early dissemination while data collection and analysis are ongoing.
METHODS: The clinical study was conducted in three phases. The first phase was to observe changes in bacterial load and culture positivity in patient sputa over time and better understand the diversity of prospective clinical samples. The second phase was to prospectively collect clinical samples for sensitivity and specificity testing of the Akonni Biosystems XDR-LFC device. Lastly, the third phase was to explore the anti-TB drug concentrations in serum throughout the drug-resistant tuberculosis treatment.
RESULTS: The methodology described includes the study design, laboratory sample handling, data collection, and the protection elements of human subjects of this clinical study to evaluate a potential new XDR-TB diagnostic device. A total of 664 participants were enrolled across the three phases. The implemented complex systems facilitated a thorough clinical data collection for an objective evaluation of the device. The study is closed to recruitment. The follow-up data collection and analysis are in progress.
CONCLUSIONS: This paper outlined a prospective cohort study protocol to evaluate a rapid XDR-TB detection device, which may be informative for other researchers with similar goals.
UNASSIGNED: DERR1-10.2196/26748.
摘要：
背景：缺乏针对广泛耐药结核病（XDR-TB）的准确有效的诊断设备，使其成为全球公共卫生的严重威胁。设计了一项预期用途队列中的前瞻性临床研究，以评估AkonniBiosystemsXDR-TBTruArray和侧向流动池（XDR-LFC），以解决结核病诊断中的这一差距。
目的：本文提出了一项研究的方案，旨在记录该评估方法的概念化和设计，以便在进行数据收集和分析的同时进行早期传播。
方法：临床研究分三个阶段进行。第一阶段是观察患者痰中细菌负荷和培养阳性随时间的变化，并更好地了解前瞻性临床样本的多样性。第二阶段是前瞻性收集临床样本，用于AkonniBiosystemsXDR-LFC装置的敏感性和特异性测试。最后,第三阶段是探索抗结核药物在耐药结核病治疗中的血清浓度.
结果：所描述的方法包括研究设计，实验室样品处理，数据收集，以及这项临床研究的人类受试者的保护元件，以评估一种潜在的新型XDR-TB诊断设备。在三个阶段共有664名参与者参加。实施的复杂系统促进了全面的临床数据收集，以便对设备进行客观评估。该研究对招募工作已关闭。正在进行后续数据收集和分析。
结论：本文概述了评估快速XDR-TB检测设备的前瞻性队列研究方案，这对于其他具有类似目标的研究人员来说可能是有益的。
■DERR1-10.2196/26748。
目的：本文提出了一项研究的方案，旨在记录该评估方法的概念化和设计，以便在进行数据收集和分析的同时进行早期传播。
方法：临床研究分三个阶段进行。第一阶段是观察患者痰中细菌负荷和培养阳性随时间的变化，并更好地了解前瞻性临床样本的多样性。第二阶段是前瞻性收集临床样本，用于AkonniBiosystemsXDR-LFC装置的敏感性和特异性测试。最后,第三阶段是探索抗结核药物在耐药结核病治疗中的血清浓度.
结果：所描述的方法包括研究设计，实验室样品处理，数据收集，以及这项临床研究的人类受试者的保护元件，以评估一种潜在的新型XDR-TB诊断设备。在三个阶段共有664名参与者参加。实施的复杂系统促进了全面的临床数据收集，以便对设备进行客观评估。该研究对招募工作已关闭。正在进行后续数据收集和分析。
结论：本文概述了评估快速XDR-TB检测设备的前瞻性队列研究方案，这对于其他具有类似目标的研究人员来说可能是有益的。
■DERR1-10.2196/26748。
