Development of a High Throughput Assay for Rapid Screening of Congenital Cytomegalovirus Infection using Dried Blood Spots

开发利用干血斑快速筛查先天性巨细胞病毒感染的高通量检测方法

• 批准号: 10323195
• 负责人: Raymond Preston Stowe
• 金额: $ 29.16万
• 依托单位: MICROGEN, LLC
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-06-10 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10323195
• 关键词: Address; Antiviral Therapy; Archives; Awareness; Biological Assay; Birth; Blood; Brain; Buffers; Cells; Child; Clinical; Clinical Sensitivity; Collection; Complex; Counseling; Cytolysis; Cytomegalovirus; DNA; Detection; Development; Diagnosis; Diagnostic; Diagnostic Reagent Kits; Disease; Economic Burden; Evaluation; Exhibits; Freeze Drying; Genetic Diseases; Goals; Health; Hearing Tests; Hospitals; Infant; Infection; Labyrinth; Language Development; Logistics; Medical; Metabolic Diseases; Methods; Neonatal; Nerve; Newborn Infant; Nucleic Acid Amplification Tests; Outcome; Patients; Personal Satisfaction; Phase; Procedures; Public Health Applications Research; Rapid screening; Reaction; Reaction Time; Reagent; Saliva; Sampling; Sensitivity and Specificity; Sensorineural Hearing Loss; Severity of illness; Small Business Innovation Research Grant; Spottings; Technology; Temperature; Testing; Texas; Time; Universities; Urine; Viral; Virus; base; clinical practice; commercial application; congenital cytomegalovirus; cost; detection limit; hearing impairment; high throughput screening; improved; infant infection; innovation; innovative technologies; instrument; isothermal amplification; neonate; non-genetic; novel; pathogen; performance tests; preservation; programs; rapid diagnosis; research and development; saliva sample; screening; screening program; sound; standard of care; technological innovation; tool; user-friendly; virtual; waiver

Project Summary Sensorineural hearing loss (SNHL), a condition where the inner ear cannot convert sound into nerve impulses to the brain, is the most common congenital disease. The leading cause of non-genetic SNHL is congenital cytomegalovirus (cCMV) infection, and the economic burden of SNHL and its detrimental effect on language development in the US is estimated at nearly $4 billion annually. Studies show that prompt antiviral therapy can improve language development in children identified with hearing loss. However, the benefits of early antiviral treatment are highly dependent on rapid diagnosis. If there are no saliva or urine samples available, diagnosis of cCMV infection in children is only possible by examining Dried Blood Spots (DBSs) that are routinely collected at birth. However, current DNA extraction methods exhibit lower sensitivity to detect CMV in DBSs when compared to saliva and urine. Microgen’s One-Step® platform, which integrates sample lysis and target amplification, is an innovative, low-cost, and user-friendly technology that can address this challenge. The goal of this project is to develop an inexpensive ($10 each) and rapid (15-25 min from sample to result) test for diagnosis of cCMV using DBSs, allowing immediate counseling and treatment. Development of Microgen’s One-Step® CMV DBS test will provide a new tool for diagnosis, especially in asymptomatic patients with delayed hearing loss.

项目摘要 感觉神经性听力损失（SNHL），内耳无法将声音转换为神经脉冲的情况 是最常见的先天性疾病。非遗传性SNHL的主要原因是先天性的 巨细胞病毒（cCMV）感染，SNHL的经济负担及其对语言的不利影响 据估计，美国每年的开发费用接近40亿美元。研究表明及时的抗病毒治疗 可以改善听力损失儿童的语言发育。然而，早期的好处 抗病毒治疗高度依赖于快速诊断。如果没有唾液或尿液样本， 儿童cCMV感染的诊断只能通过检查干燥的血斑（DBS）来进行， 出生时常规采集。然而，目前的DNA提取方法对检测CMV表现出较低的灵敏度， 与唾液和尿液相比。Microgen的One-Step®平台集成了样品裂解和 靶向扩增是一种创新、低成本和用户友好的技术，可以解决这一挑战。 该项目的目标是开发一种廉价（每个10美元）和快速（从样品到结果15-25分钟）的方法。 使用DBS进行cCMV诊断测试，允许立即咨询和治疗。发展 Microgen的One-Step® CMV DBS测试将提供一种新的诊断工具，特别是在无症状的 迟发性听力损失患者