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、特异和更容易获得的床旁技术，用于诊断性传播感染 至关重要。包括美国在内的许多国家过去都出现了性传播感染发病率急剧上升的情况 半个世纪以来，尤其是2020年。许多病例未得到诊断和治疗，30%的患者可能 在检测呈阳性后从不接受治疗。其中一些性传播感染有可能导致严重的健康问题 问题，包括不孕症，特别是如果没有及早诊断和治疗。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测试的最佳领域，因为它们可以减少随访损失， 提高患者和伴侣的治疗率，避免使用不必要的抗生素治疗。 该公司开发了一种分子床旁监护平台AmplifiDxTM DX-1000， 使用直接拭子作为样本类型的快速分子检测。该系统有五个光学通道， 检测多达4个感染性靶标加上内部对照。DX-1000与众不同，非常适合 传染病检测市场。化学是多路复用和敏感的，但简单，允许 小型化的产品，这将是有吸引力的现场护理空间。工作流程很简单-一步到位， 答案-并且不需要复杂的试剂混合或处理过程的多个阶段。实验室- 对于COVID-19，我们将在短短30分钟内提供高质量的结果。20分钟可以检测DNA 这款光滑的检测盒和仪器设计用于低成本检测， 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和相关耐药标志物检测的基础。 我们建议开发一种检测沙眼衣原体（CT）和淋病奈瑟菌的方法 (NG)以及与NG中抗生素抗性或敏感性相关的突变。我们亦建议 开发一种尿液收集设备，可以很容易地适应现有的工作流程，让医生选择 另一种样品。该检测试剂盒将与DX-1000上的泌尿生殖道拭子或尿液样本一起使用 设备和检测盒，将提供快速，可操作的诊断CT和NG在护理点，以及指导 治疗决策和通过识别抗生素相关突变促进抗生素管理。

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.