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: 10763606
• 负责人: Raymond Preston Stowe
• 金额: $ 103.45万
• 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 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10763606
• 关键词: Address; Affect; Antiviral Therapy; Awareness; Biological Assay; Birth; Birthing Centers; Blindness; Blood; Brain; Buffers; Cells; Chemicals; Child; Childhood; Clinic; Clinical; Clinical Sensitivity; Cognitive deficits; Communicable Diseases; Counseling; Cytolysis; Cytomegalovirus; Cytomegalovirus Infections; DNA; Data; Detection; Development; Diagnosis; Diagnostic; Diagnostic Reagent Kits; Diagnostic tests; Disease; Dryness; Economic Burden; Enzymes; Evaluation; Exhibits; Financial Hardship; Formulation; Goals; Health; Healthcare Systems; Hospitals; Infant; Infrastructure; Instruction; Laboratories; Labyrinth; Language Development; Manuals; Manufacturer; Medical; Methods; Morbidity - disease rate; Neonatal; Nerve; Neurologic; Newborn Infant; Nucleic Acids; Outcome; Patients; Performance; Personal Satisfaction; Phase; Polymerase; Predictive Value; Preparation; Procedures; Public Health Applications Research; Publications; Publishing; Rapid screening; Reagent; Reproducibility; Saliva; Sampling; Sensitivity and Specificity; Sensorineural Hearing Loss; Severities; Severity of illness; Site; Small Business Innovation Research Grant; Specimen; Spottings; Standardization; System; Technology; Temperature; Testing; Training; Urine; Vial device; Viral; clinical practice; commercial application; commercialization readiness; congenital cytomegalovirus; cost; disability; hearing impairment; high throughput screening; improved; in-vitro diagnostics; infant infection; innovation; instrument; isothermal amplification; manufacture; mortality; neonatal care; neonate; non-genetic; novel; pathogen; performance tests; preservation; prospective; rapid diagnosis; research and development; sample collection; screening; 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 ($25 each) and rapid (30 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.

项目概要 感音神经性听力损失 (SNHL)，一种内耳无法将声音转化为神经冲动的疾病 是最常见的先天性疾病，非遗传性 SNHL 的主要原因是先天性。 巨细胞病毒 (cCMV) 感染、SNHL 的经济负担及其对语言的困扰 研究显示，美国每年的开发费用估计接近 40 亿美元。 可以改善患有听力损失的儿童的语言发展但是，早期的好处。 如果没有唾液或尿液样本，抗病毒治疗高度依赖于快速诊断。 儿童 cCMV 感染的诊断只能通过检查干血斑 (DBS) 来实现。 然而，目前的 DNA 提取方法检测 CMV 的灵敏度较低。 DBS 与唾液和尿液相比，集成了样本裂解和尿液分析。 目标扩增是一种创新、低成本且用户友好的技术，可以应对这一挑战。 该项目的目标是开发一种廉价（每次 25 美元）且快速（从样品到结果 30 分钟）的测试 使用 DBS 诊断 cCMV，可立即提供咨询和治疗。 一步式 CMV DBS 检测将为诊断提供一种新工具，特别是对于迟发性无症状患者 听力损失。