STI NG Plus, a Swab to Answer Molecular Panel Test for Point of Care Diagnosis and Treatment Recommendation

STI NG Plus，一种拭子，可回答用于护理点诊断和治疗建议的分子面板测试

• 批准号: 10603834
• 负责人: Shoulian Dong
• 金额: $ 28.68万
• 依托单位: AMPLIFIDX INC
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-05-01 至 2025-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10603834
• 关键词: Acceleration; Advanced Development; Antibiotic Resistance; Antibiotic Therapy; Antibiotic susceptibility; Antibiotics; Area; Biological Assay; COVID-19; COVID-19 detection; COVID-19 diagnostic; Ceftriaxone; Chemistry; Chlamydia trachomatis; Clinic; Clinical; Collection; Communicable Diseases; Complex; Country; Cytolysis; DNA; Detection; Development; Devices; Diagnosis; Diagnostic tests; FDA Emergency Use Authorization; Force of Gravity; Funding; Genitourinary system; Health; Health care facility; Incidence; Infertility; Infrastructure; Liquid substance; Magnetism; Marketing; Molecular; Mutation; Neisseria gonorrhoeae; Optics; Output; Patients; Physicians; Point of Care Technology; Privacy; Process; Questionnaires; RADx; Reagent; Recommendation; Research; Resistance; Resource-limited setting; Risk; Running; Sampling; Sexually Transmitted Diseases; Surveys; Susceptibility Gene; Swab; System; Testing; Urine; Validation; Visit; assay development; design; detection assay; diagnostic tool; follow-up; in-vitro diagnostics; instrument; internal control; isothermal amplification; manufacture; manufacturing cost; miniaturize; multiplex assay; point of care; point of care testing; point-of-care diagnosis; point-of-care diagnostics; pressure; prototype; rapid diagnosis; resistance gene; social stigma; tool; usability; validation studies

ABSTRACT The need to develop sensitive, specific, and more easily available point-of-care technologies for diagnosing STIs is critical. Many countries, including the US, have seen a sharp increase in the incidence of STIs over the past half-decade, and especially since 2020. Many cases go undiagnosed and untreated, and 30% of patients may never get treatment after testing positive. Some of these STIs have the potential to cause serious health problems, including infertility, especially if not diagnosed and treated early. Stigma, privacy, and confidentiality issues make STIs optimal areas for POC tests at healthcare facilities, as they can reduce loss to follow-up, increase patient and partner treatment rates, and avoid the use of unnecessary antibiotic treatment. The company has developed a Molecular Point of Care platform, the AmplifiDxTM DX-1000, which is capable of rapid, molecular testing using direct swabs as the sample type. The system has five optical channels, allowing detection of up to 4 infectious targets plus an internal control. The DX-1000 is differentiated and well-suited for the infectious disease testing market. The chemistry is multiplexed and sensitive, yet simple, allowing for a miniaturized product that will be attractive in the point-of-care space. The workflow is easy - one-step, swab to answer - and does not require complex mixing of reagents or handling of multiple stages of the process. Lab- quality results will be delivers in as little as 30 minutes for COVID-19. 20 minutes are possible for DNA parameters as the number of assay steps can be less. The sleek cartridge and instrument are designed for low- cost manufacturing. AmplifiDx is poised to submit a first Emergency Use Authorization (EUA) to the FDA for a COVID-19 diagnostic, which is the basis for the proposed assay for STIs and relevant resistance markers. We propose the development of an assay which will detect Chlamydia trachomatis (CT) and Neisseria gonorrhea (NG), as well as mutations associated with antibiotic resistance or susceptibility in NG. We also propose the development of a urine collection device that fits easily in to the existing workflow, to give doctors the choice of another sample type. This assay, which will be used with urogenital swabs or urine samples on the DX-1000 device and cartridge, will provide quick, actionable diagnosis for CT and NG at point of care, as well as guiding treatment decisions and promoting antibiotic stewardship by identifying antibiotic-related mutations.

抽象的 需要开发敏感、特异且更容易获得的护理点技术来诊断性传播感染 很关键。过去，包括美国在内的许多国家的性传播感染发病率急剧上升 五年来，尤其是 2020 年以来。许多病例未经诊断和治疗，30% 的患者可能 检测呈阳性后切勿接受治疗。其中一些性传播感染有可能导致严重的健康问题 问题，包括不孕不育，特别是如果不及早诊断和治疗的话。耻辱、隐私和保密 这些问题使性传播感染成为医疗机构进行 POC 检测的最佳领域，因为它们可以减少随访损失， 提高患者和伴侣的治疗率，并避免使用不必要的抗生素治疗。 该公司开发了分子护理点平台 AmplifiDxTM DX-1000，该平台能够 使用直接拭子作为样本类型进行快速分子检测。该系统有五个光通道，允许 检测多达 4 个感染目标以及一个内部对照。 DX-1000 与众不同，非常适合 传染病检测市场。该化学反应是多重的、敏感的，但又简单，允许 小型化产品将在护理点领域具有吸引力。工作流程很简单 - 一步，用拭子擦拭 答案 - 并且不需要复杂的试剂混合或过程的多个阶段的处理。实验室- COVID-19 的高质量结果将在短短 30 分钟内提供。 DNA 可能需要 20 分钟 参数，因为测定步骤的数量可以更少。时尚的墨盒和仪器专为低 成本制造。 AmplifiDx 准备向 FDA 提交第一份紧急使用授权 (EUA) COVID-19 诊断，这是拟议的 STI 和相关耐药标记检测的基础。 我们建议开发一种检测沙眼衣原体 (CT) 和淋病奈瑟菌的检测方法 (NG)，以及与 NG 中抗生素耐药性或敏感性相关的突变。我们还建议 开发一种易于融入现有工作流程的尿液收集装置，为医生提供选择 另一种样本类型。该检测将在 DX-1000 上与泌尿生殖拭子或尿液样本一起使用 设备和盒，将为护理点 CT 和 NG 提供快速、可操作的诊断，并指导 通过识别抗生素相关突变来做出治疗决策并促进抗生素管理。