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

摘要 需要开发敏感、具体和更容易获得的诊断性传播感染的护理点技术 是至关重要的。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，尤其是自2020年以来。许多病例没有得到诊断和治疗，30%的患者可能 在检测呈阳性后永远不能接受治疗。其中一些性传播疾病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。耻辱、隐私和机密性 这些问题使得STI成为医疗机构POC测试的最佳区域，因为它们可以减少随访的损失， 提高患者和伴侣的治疗率，避免使用不必要的抗生素治疗。 该公司已经开发了一种分子护理点平台AmplifiDxTM DX-1000，它能够 使用直接拭子作为样本类型的快速分子检测。该系统有五个光通道，允许 检测最多4个感染目标，外加内部控制。DX-1000与众不同，非常适合 传染病检测市场。这种化学反应是多重的和敏感的，但很简单，允许 在护理点领域具有吸引力的微型化产品。工作流程很简单--只需一步即可完成 答案-不需要复杂的试剂混合或处理过程的多个阶段。实验室- 新冠肺炎将在短短30分钟内交付高质量的结果。DNA检测20分钟是可能的 参数作为分析步骤的数量可以更少。圆滑的墨盒和仪器是为低成本设计的 制造成本。AmplifiDx准备向FDA提交第一份紧急使用授权(EUA) 新冠肺炎诊断，这是拟议的性传播感染和相关耐药性标记物检测的基础。 我们建议建立一种检测沙眼衣原体(CT)和淋病奈瑟菌的方法 (Ng)，以及与NG的抗生素耐药性或敏感性相关的突变。我们还提出了 开发一种易于适应现有工作流程的尿液收集设备，让医生可以选择 另一种样本类型。这项检测将用于DX-1000上的泌尿生殖器拭子或尿样 设备和墨盒，将在护理点为CT和NG提供快速、可行的诊断以及指导 通过识别与抗生素相关的突变，作出治疗决策并促进抗生素管理。

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.