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

本提案旨在解决肝吸虫华支睾吸虫和活毒毛吸虫对高危人群（包括过去几十年在东南亚为军事或政府服务的人员）造成的重大公共卫生威胁。两种肝吸虫的感染与胆管癌（一种高度致命的胆管癌）的高风险相关。支睾吸虫病和蛇吸虫病影响全世界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，军人、移民和从这些地区返回的旅行者可能由于活跃或过去的感染而面临胆管癌的风险。该项目解决了缺乏现成的测试肝吸虫感染在美国通过发展筛选和点护理分析。二期将专注于完成ELISA和侧流（LF）测试的开发、测试性能评估的临床研究、生产规模扩大、ELISA作为CLIA实验室测试的验证、FDA批准的监管申请、CE标志以及在东南亚的分销。酶联免疫吸附试验和侧流试验将是在美国开发并商业化的首个经验证的华支睾吸虫病和蛇肺吸虫病检测方法

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.