Lab-on-a-chip for Neonatal Hyperbilirubinemia Screening

用于新生儿高胆红素血症筛查的芯片实验室

• 批准号: 7748101
• 负责人: Vijay Srinivasan
• 金额: $ 18.94万
• 依托单位: ADVANCED LIQUID LOGIC
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-09-22 至 2011-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7748101
• 关键词: Academy; Acute; Ambulatory Care Facilities; American; Auditory; Bilirubin; Biological Assay; Blood; Blood specimen; Brain Injuries; Chemistry; Clinical; Clinical Chemistry; Cretinism; Cutaneous; Development; Devices; Diagnosis; Diagnostic; Disease; Early identification; Early treatment; Frequencies; Functional disorder; Glucosephosphate Dehydrogenase; Glucosephosphate Dehydrogenase Deficiency; Goals; Guidelines; Health Campaign; Hospitals; Hour; Human Resources; Hyperbilirubinemia; Icterus; Immunoassay; Incidence; Infant; Inherited; Kernicterus; Laboratories; Life; Liquid substance; Logic; Measurement; Measures; Microfluidics; Movement Disorders; Neonatal Jaundice; Neurologic Dysfunctions; Newborn Infant; Patient Discharge; Patients; Pediatrics; Phase; Process; Public Health; Recommendation; Refractory; Resources; Risk; Rural Community; Screening procedure; Serum; Services; Side; Site; Speed; Systems Integration; Technology; Test Result; Testing; Thyrotropin; Time; Translating; Venous blood sampling; Whole Blood; assay development; base; cost; design; digital; instrument; micro-total analysis system; neonatal hyperbilirubinemia; neonate; new technology; point of care; prevent; public health relevance; rapid diagnosis; research and development; total measurement Bilirubin

DESCRIPTION (provided by applicant): Despite aggressive public health campaigning and strict guidelines for diagnosis and treatment, the estimated incidence of severe hyperbilirubinemia (defined as serum bilirubin levels greater than 99th percentile) is 1:70. Severe hyperbilirubinemia can cause a spectrum of neurologic dysfunction of which kernicterus is the most concerning. Kernicterus manifests as a life-long movement disorder with occulomotor and auditory dysfunction. The subcommittee on Hyperbilirubinemia of the American Academy of Pediatrics (AAP) has proposed guidelines to reduce the frequency of severe neonatal hyperbilirubinemia and bilirubin encephalopathy. These include the recommendation to measure total serum bilirubin level or cutaneous bilirubin level of all infants with jaundice in the first 24 hours of life. The committee also identified the need for screening for hereditary causes such as G6PD deficiency and congenital hypothyroidism, which if present can change the treatment completely. Early identification and initiation of treatment can prevent acute bilirubin encephalopathy and kernicterus. Currently testing for hyperbilirubinemia is often available at the point of care, but results are usually returned after patient discharge. Tests for G6PD and CH are usually done only if the patient does not respond to therapy. In this proposal, we describe a new technology that has the potential to dramatically simplify the testing process and expedite the availability of test results. Time is of the essence in diagnosis of these newborn conditions as significant brain injury can be prevented by prompt treatment. This new technology will require minimal resources, will be low cost, and will be suitable for use in hospitals, outpatient clinics, and rural communities. Availability of portable and multiplex devices for on-site screening will enable rapid diagnosis of at-risk infants. Development of a device that could perform multiple assays for common newborn disorders at the point-of-care with rapid turnaround is an initial step in the development of multiplex testing with an on-site portable device. PUBLIC HEALTH RELEVANCE: Advanced Liquid Logic, Inc. is developing a lab-on-a-chip on its proprietary digital (droplet-based) microfluidic platform for clinical diagnostics. The proposed project aims to demonstrate a near-patient platform for screening neonates with very high levels of bilirubin (hyperbilirubinemia). The device would be greatly useful in rapid identification and enable early treatment.

描述（由申请方提供）：尽管开展了积极的公共卫生活动，并制定了严格的诊断和治疗指南，但重度高胆红素血症（定义为血清胆红素水平大于第99百分位数）的估计发生率为1：70。严重的高胆红素血症可引起一系列神经功能障碍，其中核黄疸是最值得关注的。核黄疸表现为一种终生的运动障碍，伴有视力和听觉功能障碍。美国儿科学会（AAP）的高胆红素血症小组委员会提出了减少严重新生儿高胆红素血症和胆红素脑病发生频率的指南。其中包括建议在出生后24小时内测量所有黄疸婴儿的总血清胆红素水平或皮肤胆红素水平。该委员会还确定了筛查遗传性原因的必要性，如G6PD缺乏症和先天性甲状腺功能减退症，如果存在，可以完全改变治疗。早期发现和治疗可以预防急性胆红素脑病和核黄疸。目前，高胆红素血症的检测通常可以在护理点进行，但结果通常在患者出院后返回。G6PD和CH的测试通常只有在患者对治疗没有反应时才进行。在本提案中，我们描述了一种新技术，该技术有可能大大简化测试过程并加快测试结果的可用性。在诊断这些新生儿疾病时，时间至关重要，因为可以通过及时治疗预防严重的脑损伤。这项新技术将需要最少的资源，成本低，并将适用于医院，门诊诊所和农村社区。提供便携式和多路设备进行现场筛查将能够快速诊断高危婴儿。开发一种可以在护理点快速周转对常见新生儿疾病进行多种检测的设备是开发现场便携式设备进行多重检测的第一步。公共卫生相关性：Advanced Liquid Logic，Inc.正在其专有的数字（基于液滴）微流体平台上开发用于临床诊断的芯片实验室。拟议项目旨在展示一个近患者平台，用于筛查胆红素水平非常高（高胆红素血症）的新生儿。该设备将在快速识别和早期治疗方面非常有用。