PHS 2022-1 TOPIC 440 - CANCER PREVENTION & DIAGNOSIS TECHNOLOGIES FOR LOW-RESOURCE SETTINGS

高危人乳头瘤病毒（hrHPV）的快速护理点检测将使医生能够在常规护理中快速识别高危患者，并在宫颈癌和肛门癌筛查和诊断中进行下一步。所提出的系统建立在下一代分子诊断平台上，该平台以当前检测成本的一小部分提供高灵敏度和选择性性能，使用可检测15 hrHPV类型的市售检测试剂盒，并对高危HPV16和HPV18进行特异性检测。具体目标1涉及将现有HPV检测试剂盒整合和优化到当前检测盒中，并将分析灵敏度与现有HPV检测试剂盒进行比较。目的2将临床性能与现有FDA批准的系统进行比较。目的3比较患者自采集与临床医生采集的患者拭子的结果。在医生办公室使用拟议的HPV检测系统将为宫颈癌和肛门癌筛查提供更好的检测机会，特别是在农村或偏远地区等实验室有限的地方。该系统被设计为CLIA豁免测试，也可以通过使用患者从子宫颈或肛门收集的拭子进行自我采集来实施，进一步增加了HPV筛查的患者可及性，灵活性和医疗保健成本效益。

A rapid point of care test for high-risk human papillomavirus HPV (hrHPV) would allow doctors to quickly identify high risk patients during routine care and perform next steps in cervical and anal cancer screening and diagnosis. The proposed system is built on a next-generation molecular diagnostic platform which provides high sensitivity and selectivity performance at a fraction of current testing costs, using a commercially available assay that can detect 15 hrHPV types with specific call-outs for high-risk HPV16 and HPV18. Specific Aim 1 involves the integration and optimization of the existing HPV assay kit into the current cartridge, and will compare analytical sensitivity to an existing HPV assay. Aim 2 compares clinical performance to an existing FDA-approved system. Aim 3 compares results from patient self-collected to clinician-collected patient swabs. Use of the proposed HPV test system at a doctor’s office will provide better test access for cervical and anal cancer screening, especially in locations with limited access to laboratories such as rural or remote areas. The system is designed as a CLIA Waived test, and can also be implemented through self-collection using swabs collected by patients from the cervix or anus, further increasing patient access, flexibility and healthcare cost-effectiveness of HPV screening.