TOPIC 388: IN VITRO DIAGNOSTIC FOR THE LIVER FLUKES OPISTHORCHIS VIVERRINI AND CLONORCHIS SINENSI

主题 388：肝吸虫后睾吸虫和华支睾吸虫的体外诊断

• 批准号: 10498670
• 负责人: ANDREW LEVIN
• 金额: $ 200万
• 依托单位: KEPHERA DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-16 至 2023-09-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10498670
• 关键词: Address; Affect; Area; Asians; Bile duct carcinoma; Biological Assay; Cholangiocarcinoma; Clinical Research; Clonorchiasis; Clonorchis sinensis; Development; Enzyme-Linked Immunosorbent Assay; Far East; Fasciola hepatica; Government; Human; Human Resources; Immigrant; Infection; Laboratories; Military Personnel; Opisthorchiasis; Opisthorchis viverrini; Phase; Population; Production; Public Health; Risk; Services; Southeastern Asia; Testing; Thailand; Validation; Vietnam; evaluation/testing; in-vitro diagnostics; lateral flow assay; liver development; manufacturing scale-up; military service; performance tests; point of care; scale up; screening

This proposal addresses the significant public health threat posed by the liver flukes Clonorchis sinensis and Opisthorchis viverrini in at-risk human populations including personnel stationed in Southeast Asia for military or government service in previous decades. Infection with the two liver flukes is associated with a greater risk for cholangiocarcinoma, a highly lethal cancer of the bile ducts. Clonorchiasis and Opisthorchiasis affect over 35 million people worldwide, principally in East and Southeast Asia. As liver fluke infection can persist up to several decades, military service personnel, immigrants and travelers returning from these areas may be at risk for cholangiocarcinoma due to an active or past infection. This project addresses the lack of readily available tests for liver fluke infection in the U.S. through development of screening and point-of-care assays. Phase II will focus on completing development of ELISA and lateral flow (LF) tests, clinical studies for evaluation of test performance, manufacturing scale-up, validation of the ELISA as a CLIA laboratory test, and regulatory submissions for FDA clearance, CE mark, and distribution in Southeast Asia. The ELISA and lateral flow tests will be the first validated tests for Clonorchiasis and Opisthorchiasis to be developed and made commercially available in the U.S.

该提案解决了肝吸虫Clonelysis sinensis和Opisthorchis viverrini在高危人群中造成的重大公共卫生威胁，包括过去几十年驻扎在东南亚的军事或政府服务人员。 两种肝吸虫感染与胆管癌的风险更大有关，胆管癌是一种高度致命的胆管癌。 华支睾吸虫病和后睾吸虫病影响全世界3500多万人，主要在东亚和东南亚。 由于肝吸虫感染可持续数十年，从这些地区返回的军人，移民和旅行者可能因活动性或既往感染而有患胆管癌的风险。该项目通过开发筛查和即时检测方法，解决了美国缺乏现成的肝吸虫感染检测方法的问题。 第二阶段的重点是完成ELISA和侧向流（LF）检测的开发，用于评估检测性能的临床研究，生产规模扩大，ELISA作为CLIA实验室检测的验证，以及FDA批准，CE认证和东南亚分销的监管提交。ELISA和侧流试验将是美国开发和商业化的首个经验证的华支睾吸虫病和后睾吸虫病试验。