Point-of-Care Nucleic Acid Test for Cytomegalovirus for Newborn Hearing Screening

用于新生儿听力筛查的巨细胞病毒护理点核酸检测

基本信息

批准号：
8452247
负责人：
VAMSEE K. PAMULA
金额：
$ 19.87万
依托单位：
ADVANCED LIQUID LOGIC
依托单位国家：
美国
项目类别：
财政年份：
2012
资助国家：
美国
起止时间：
2012-12-01 至 2013-05-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8452247
关键词：
Address Affect Alabama Archives Automation Biochemical Biological Assay Birth Blood Clinical Collaborations Cytomegalovirus Cytomegalovirus Infections DNA amplification Detection Development Early Diagnosis Early Intervention Funding Gene Mutation Genes Gold Health Hearing Hospitals Infant Intellectual functioning disability Laboratories Liquid substance Logic Methodology Methods Microfluidics Miniaturization Molecular Mutation National Institute on Deafness and Other Communication Disorders Neonatal Neonatal Screening Newborn Infant Nucleic Acid Amplification Tests Performance Phase Physiology Postpartum Period Preparation Protocols documentation Public Health Research Research Infrastructure Research Personnel Risk Saliva Sampling Sensitivity and Specificity Simulate Source Specimen Spottings Symptoms System Technology Testing Therapeutic Intervention Time Translating Universities aminoglycoside-induced ototoxicity base congenital cytomegalovirus congenital infection cost deafness design digital disability flexibility hearing impairment hearing screening human GJB2 protein improved infant outcome innovation instrument internal control magnetic beads micro-total analysis system new technology nucleic acid detection point of care prevent programs public health relevance screening success viral DNA

项目摘要

DESCRIPTION (provided by applicant): Universal newborn hearing screening is mandated in the US and is performed in the postpartum hospital setting. Current physiology-based hearing screening tests are unable to detect late-onset hearing loss caused by cytomegalovirus (CMV) infection. Therefore, a complementary screening approach has been suggested to prevent disabilities associated with CMV-related hearing loss by early detection and intervention. A nucleic acid test has been described to screen newborns for congenital CMV infection using saliva specimens where it is more sensitive than the dried blood spots traditionally used by the newborn screening laboratories. Newborn screening programs do not have the infrastructure necessary to use newborn saliva samples and molecular assays. Advanced Liquid Logic's digital microfluidic technology is a recognized innovative, low-cost, and automated liquid handling system that can address this challenge. The objective of this Fast-Track application is to develop an integrated lab-on-a-chip to perform screening of congenital CMV infection in newborns using saliva samples. Specific aims in Phase I are to develop protocols for CMV purification from saliva samples and for viral DNA amplification on-cartridge, and to integrate a "sample-to-answer" CMV screening assay on the digital microfluidic platform. Success in Phase I will result in a Phase II continuation where the specific aims will be (i) to develop a point-of-care newborn screening platform, (ii) to optimize the "sample-to-answer" CMV protocol in this platform and assess its analytical performance, and (iii) to perform a method comparison with the "gold standard" rapid saliva culture using neonatal saliva samples in collaboration with the University of Alabama at Birmingham.

描述（由申请人提供）：美国强制要求对新生儿进行全面听力筛查，并在产后医院进行。目前基于生理学的听力筛查测试无法检测巨细胞病毒（CMV）感染引起的迟发性听力损失。因此，建议采用补充筛查方法，通过早期发现和干预来预防与巨细胞病毒相关的听力损失相关的残疾。据描述，核酸检测使用唾液样本筛查新生儿是否患有先天性巨细胞病毒感染，该检测比新生儿筛查实验室传统上使用的干血斑更敏感。新生儿筛查项目没有使用新生儿唾液样本和分子检测所需的基础设施。 Advanced Liquid Logic 的数字微流体技术是公认的创新、低成本和自动化液体处理系统，可以应对这一挑战。该快速通道应用的目标是开发一个集成的芯片实验室，利用唾液样本对新生儿进行先天性 CMV 感染筛查。第一阶段的具体目标是开发从唾液样本中纯化 CMV 和在盒上进行病毒 DNA 扩增的方案，并将“样本到答案”CMV 筛选测定集成到数字微流体平台上。第一阶段的成功将导致第二阶段的延续，具体目标是 (i) 开发护理点新生儿筛查平台，(ii) 优化该平台中的“样本到答案”CMV 协议并评估其分析性能，(iii) 与伯明翰阿拉巴马大学合作，使用新生儿唾液样本与“黄金标准”快速唾液培养进行方法比较。