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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.

项目总结