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Low Cost Point-Of-Care Test For CMV

低成本 CMV 护理点测试

基本信息

批准号：
9891788
负责人：
Raymond Preston Stowe
金额：
$ 12.22万
依托单位：
MICROGEN, LLC
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-06-01 至 2020-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9891788
关键词：
Address Affect Archives Area Bedside Testings Biological Assay Buffers Child Clinical Clinical Pathology Congenital Abnormality Counseling Cytolysis DNA Detection Development Developmental Disabilities Diagnostic Ensure Equipment Evaluation Failure Fluorescence Future Genes Genome Goals Guidelines Hospitals In Vitro Infrastructure Label Laboratories Laboratory Research Letters Mediating Medicine Methods Monitor Neonatal Neonatal Screening Outcome Performance Phase Pilot Projects Polymerase Gene Preventive Intervention Reaction Reader Refrigeration Reporter Saliva Sampling Sensitivity and Specificity Signal Transduction Site Specificity Specimen Surgical Flaps Technology Testing Time Training United States Food and Drug Administration Vial device Viral college congenital cytomegalovirus cost cost effective design diagnostic assay fluorophore innovation internal control molecular diagnostics novel strategies point of care prenatal testing sample collection screening tissue culture tv watching

项目摘要

Project Summary Congenital Cytomegalovirus (CMV) infection is a leading cause of birth defects and developmental disabilities in the U.S., affecting thousands of children each year. Current methods (e.g., tissue culture, shell vial assay, single-copy gene PCR methods, etc.) to detect CMV infections are labor intensive and require sophisticated equipment, dedicated laboratory space, and trained technicians. A rapid, on-site test for newborn screening that could detect CMV in clinical specimens would: (1) allow for immediate counseling and additional specimen collection for confirmatory testing, and (2) avoid having to create new laboratory infrastructure for widespread biospecimen testing. We propose developing a point-of-care test for rapid screening of congenital CMV infection. This technology will also result in a significant cost reduction as compared to hospital and clinical pathology laboratory tests. The goal of this project is to develop an inexpensive ($10-15 per sample) and rapid (<30 min from specimen to result) screening assay for primary CMV infections.

项目摘要先天性巨细胞病毒感染是导致出生缺陷和发育障碍的主要原因在美国，每年影响成千上万的儿童。当前的方法（例如，组织培养，壳瓶测定，单拷贝基因PCR方法等）检测CMV感染是劳动密集型的，需要复杂的设备、专用实验室空间和训练有素的技术人员。新生儿筛查的快速现场检测能够在临床标本中检测CMV的方法将：（1）允许立即咨询和额外的标本收集用于验证性测试，以及（2）避免为广泛的生物样本检测我们建议开发一种快速筛查先天性CMV的即时检测方法感染与医院和临床相比，该技术还将显著降低成本。病理学实验室检查。该项目的目标是开发一种廉价（每个样品10 -15美元）和快速的（从样本到结果<30分钟）用于原发性CMV感染的筛查测定。