Center to Advance POC Diagnostics for Global Health

全球健康 POC 诊断推进中心

• 批准号: 7886712
• 负责人: Matthew Steele
• 金额: $ 33.36万
• 依托单位: PATH
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7886712
• 关键词: Address; Back; Biological Assay; Biological Markers; CD4 Lymphocyte Count; Calibration; Characteristics; Clinic; Clinical; Databases; Developed Countries; Developing Countries; Development; Device or Instrument Development; Devices; Diagnostic; Disclosure; Emerging Technologies; Evaluation; Evaluation Reports; Grant; HIV; HIV Seropositivity; Health; Housing; Immunoassay; Institution; Investments; Laboratories; Location; Maintenance; Malaria; Marketing; Medical Device; Methods; Patients; Performance; Phase; Pregnant Women; Preparation; Primary Health Care; Process; Reader; Reference Standards; Refrigeration; Research; Resources; Sampling; Screening procedure; Source; Staging; Syphilis; System; Technology; Technology Transfer; Testing; Time; Training; Universities; base; clinical research site; cost; design; evaluation/testing; interest; meetings; minimally invasive; novel; point-of-care diagnostics; prototype; research and development; research clinical testing; stability testing; tool

Summary Novel and emerging technologies create new opportunities to address clinical needs in low-resource settings (LRS). In Cores 2 and 3, the Center will assess clinical needs in LRS and match them with emerging technologies and appropriate biomarkers. In Core 1, the center will evaluate early prototype devices for their application as point-of-care (POC) diagnostic tools in LRS. We will select devices to be evaluated under Core 1 activities through a process centered around three main themes: (1) health impact and stakeholder acceptance, (2) relevance of attributes to the needs and realities of LRS, and (3) market issues relevant to LRS. The themes are explained in further detail in Core 2. We expect to select from a variety of sources, such as academic, commercial, and nonprofit research groups identified through a formal solicitation process (described in Core 2); from a database of unsolicited technology disclosures, which PATH regularly receives; and from disclosures from our network of technology transfer offices at universities and other institutions that have agreed to partner with us on the Center grant. Using the findings from the Core 1 clinical evaluation phase, we will* select promising early prototypes for transition to later-stage (beta) prototypes that meet the specifications that justify further largescale clinical testing. For Core 1 projects, we will select prototype diagnostic devices that are expected to achieve some or all of these characteristics: ¿ Low per-test cost. ¿ Easy-to-use; minimal training requirements. ¿ Uses minimally invasive samples. ¿ Minimal upfront investment in device/reader. ¿ Minimal maintenance and calibration. ¿ Applicable to multiple analytical targets that are of interest in developing countries (either platforms capable of multiplexing or single-plexed assay platforms usable for various targets). ¿ Minimal/no external sample preparation needed. ¿ Makes use of assay supplies that are stable under elevated temperatures¿no refrigeration needed. ¿ Portable to field locations. The Center will evaluate early prototype devices that fulfill as many of these requirements as possible. These prototypes should also have reached a stage of development at which we can move quickly from initial laboratory-based evaluation to field-based clinical testing with no significant design or manufacturing challenges. Most likely, such devices will be novel platforms with broad applicability, as opposed to novel tests based on existing platforms, although this requirement is not absolute. This clinical evaluation process, performed collaboratively with the diagnostics developers under Core 1, will involve three stages: in-house laboratory evaluation, field evaluation, and report and transition. ¿ 1: In-house laboratory evaluation Testing of device or technology specifications and performance, stability tests, and preliminary evaluation of training materials will be performed at PATH using PATH'S laboratory and shop capabilities and expertise in diagnostic and medical device development and evaluation. ¿ 2: Field evaluation Field testing will be carried out at clinical sites emulating final-use conditions. The tests will use clinical samples and appropriate reference standards and methods for comparison. ¿ 3: Evaluation report and transition The evaluation report will include: results from the in-house laboratory evaluation, results from the field evaluations, and device assessments performed under Core 3. We have allocated a period of time to discuss the evaluation findings with the developers and options for the transition to the next phase of clinical testing. Each diagnostic device will progress through these three stages of evaluation. However, it is anticipated that each device will have its own unique performance criteria and characteristics. The evaluation process will be tailored to fit each device without compromising the integrity or rigorous scrutiny of the evaluation process. If a diagnostic device fails to meet predetermined performance standards at any point during the evaluation, it will be sent back into the iterative research and development loop to address the stated need.

概括 新颖和新兴技术为满足资源匮乏的临床需求创造了新的机会 设置（LRS）。在核心 2 和 3 中，中心将评估 LRS 的临床需求并将其与 新兴技术和适当的生物标志物。在核心 1 中，该中心将评估早期原型 设备作为 LRS 中的护理点 (POC) 诊断工具。 我们将通过围绕三个方面的流程，选择要在核心 1 活动下进行评估的设备 主题：(1) 健康影响和利益相关者接受度，(2) 属性与需求的相关性和 LRS 的现实情况，以及 (3) 与 LRS 相关的市场问题。这些主题在核心 2 中有更详细的解释。 我们希望从各种来源中进行选择，例如学术、商业和非营利研究 通过正式征集流程确定的群体（核心 2 中所述）；来自未经请求的数据库 PATH 定期收到的技术披露；以及我们网络的披露 同意与我们合作的大学和其他机构的技术转让办公室 中心拨款。利用核心 1 临床评估阶段的结果，我们将*选择有前途的早期 用于过渡到后期（测试版）原型的原型，这些原型满足证明进一步大规模化的规格 临床测试。 对于核心 1 项目，我们将选择预计实现部分或全部的原型诊断设备 这些特点： ¿ 每次测试成本低。 便于使用;最低的培训要求。 ¿ 使用微创样本。 ¿ 设备/阅读器的前期投资最少。 ¿ 最少的维护和校准。 ¿ 适用于发展中国家感兴趣的多个分析目标（无论是平台 能够用于各种靶标的多重或单重测定平台）。 ¿ 最少/无需外部样品制备。 ¿ 使用在高温下稳定的分析用品——无需冷藏。 ¿ 可携带至现场。 该中心将评估尽可能满足这些要求的早期原型设备。 这些原型也应该已经达到了我们可以快速从 从最初的实验室评估到基于现场的临床测试，没有重大的设计或制造 挑战。最有可能的是，此类设备将是具有广泛适用性的新颖平台，而不是新颖的平台。 基于现有平台的测试，尽管这个要求不是绝对的。 该临床评估流程是与核心 1 下的诊断开发人员合作执行的，将 涉及三个阶段：内部实验室评估、现场评估、报告和过渡。 ¿ 1: 内部实验室评估 设备或技术规格和性能测试、稳定性测试和初步测试 培训材料的评估将在 PATH 的实验室和商店进行 诊断和医疗设备开发和评估方面的能力和专业知识。 ¿ 2: 现场评估 现场测试将在模拟最终使用条件的临床地点进行。测试将使用临床 样品和适当的参考标准和比较方法。 ¿ 3：评估报告和过渡 评估报告将包括：内部实验室评估结果、现场评估结果 评估和在核心 3 下进行的设备评估。我们分配了一段时间来 与开发商讨论评估结果以及过渡到下一阶段的选项 临床测试。 每个诊断设备都将经历这三个评估阶段。不过，预计 每个设备都有自己独特的性能标准和特征。评估过程 将根据每个设备进行定制，而不影响评估的完整性或严格审查 过程。如果诊断设备在诊断过程中的任何时候未能满足预定的性能标准 评估后，它将被送回迭代研发循环以满足既定需求。