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

SBIR 第一期奖主题 388：维韦里尼后睾吸虫和华支睾吸虫的筛查和护理点诊断分析

• 批准号: 10022031
• 负责人: Andrew Levin
• 金额: $ 30万
• 依托单位: KEPHERA DIAGNOSTICS, LLC
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-16 至 2020-06-15
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10022031
• 关键词: Address; Affect; Antigens; Area; Award; Bedside Testings; Bile duct carcinoma; Biological Assay; Cholangiocarcinoma; Clonorchiasis; Clonorchis sinensis; Development; Diagnostic tests; Disease; Enzyme-Linked Immunosorbent Assay; Far East; Fasciola hepatica; Government; Human; Human Resources; Immigrant; Immunoassay; Individual; Infection; Lateral; Military Personnel; Opisthorchiasis; Opisthorchis viverrini; Parasites; Parasitic infection; Patients; Performance; Phase; Population; Public Health; Risk; Serologic tests; Serum; Services; Small Business Innovation Research Grant; Southeastern Asia; Specificity; Testing; diagnostic assay; experience; point of care; point-of-care diagnostics; prototype; 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 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.

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的流行地区。由于肝吸虫感染可持续数十年，从这些地区返回的军人，移民和旅行者可能会继续经历活动性感染。可以检测肝吸虫感染的诊断测试在美国还不容易获得。在本项目中，将开发筛查和即时血清学测试。第一阶段的重点是鉴定两种寄生虫的高灵敏度和高特异性的合适抗原，开发原型ELISA和侧流测定法，并通过评估肝吸虫患者和对照血清的原型测定性能来证明可行性。拟议的ELISA和侧流检测将是第一个高度准确的华支睾吸虫病和后睾吸虫病的测试，将在美国商业化。