SBIR Phase I Award Topic 388: Screening and Point of Care Diagnostic Assays for Opisthorchis Viverrini and Clonorchis Sinensis

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流行区。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继续经历活动性感染。在美国，可以检测肝吸虫感染的诊断测试并不容易获得。在这个项目中，筛查和即时血清学测试将被开发出来。第一阶段将专注于为两种寄生虫鉴定高灵敏度和高特异性的合适抗原，开发原型ELISA和横向流动试验，并通过评估原型试验在肝吸虫患者和对照组血清中的性能来证明可行性。拟议的ELISA和横向流动测定法将是美国首个用于华支睾吸虫病和蛇肺吸虫病的高度准确的商业检测方法

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 endemic regions of 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 continue to experience active infection. Diagnostic tests that can detect liver fluke infections are not readily available in the U.S. In this project, screening and point-of-care serological tests will be developed. Phase I will focus on identification of suitable antigens with high sensitivity and high specificity for the two parasites, development of prototype ELISA and lateral flow assays and demonstration of feasibility through assessment of prototype assay performance on sera from liver fluke patients and controls. The proposed ELISA and lateral flow assays will be the first highly accurate tests for Clonorchiasis and Opisthorchiasis to be made available commercially in the U.S.