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

• 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
• 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

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）：在美国，普遍新生儿听力筛查是强制性的，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由巨细胞病毒（CMV）感染引起的迟发性听力损失。因此，建议采用一种补充筛查方法，通过早期发现和干预来预防与CMV相关听力损失相关的残疾。已经描述了使用唾液样本筛查新生儿先天性CMV感染的核酸测试，其中它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一种公认的创新、低成本和自动化液体处理系统，可以应对这一挑战。该快速通道应用程序的目标是开发一种集成的芯片实验室，以使用唾液样本对新生儿先天性CMV感染进行筛查。第一阶段的具体目标是开发用于从唾液样品中纯化CMV和用于盒上病毒DNA扩增的方案，并在数字微流体平台上集成“样品到答案”CMV筛选测定。第一阶段的成功将导致第二阶段的继续，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方案并评估其分析性能，及（iii）与“金标准”进行方法比较与伯明翰的亚拉巴马大学合作，使用新生儿唾液样本进行快速唾液培养。