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

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要感觉神经听力损失（SNHL），这种情况使内耳无法将声音转化为神经冲动大脑是最常见的先天性疾病。非基因SNHL的主要原因是先天性巨细胞病毒（CCMV）感染，SNHL的经济伯恩及其对语言的不利影响美国的发展估计为每年近40亿美元。研究表明，促使抗病毒疗法可以改善听力损失的儿童的语言发展。但是，早期的好处抗病毒治疗高度取决于快速诊断。如果没有唾液或尿液样本，仅通过检查血液点（DBS）的诊断儿童中CCMV感染才有可能通常在出生时收集。但是，当前的DNA提取方法暴露了较低灵敏度以检测CMV 与唾液和尿液相比，DBSS。 MICRAGE的一步平台，该平台整合了样品裂解和目标放大是一种创新，低成本和用户友好的技术，可以应对这一挑战。该项目的目的是开发廉价（每人25美元）和快速（从样本到结果30分钟）测试用于使用DBS诊断CCMV，可以立即进行咨询和治疗。 MICRAGEN的发展一步CMV DBS测试将为诊断提供一种新工具，尤其是在不对称患者中听力损失。