Lab-on-a-chip for Neonatal Hyperbilirubinemia Screening

描述(申请人提供)：尽管积极的公共卫生运动和严格的诊断和治疗指南，严重的高胆红素血症(定义为血清胆红素水平大于99%)的估计发病率为1：70。严重的高胆红素血症可引起一系列神经功能障碍，其中以核黄体炎最令人担忧。核黄蜂表现为终生运动障碍，伴有隐蔽运动和听觉功能障碍。美国儿科学会(AAP)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率的指南。这些措施包括建议测量所有婴儿在出生后24小时内的血清总胆红素水平或皮肤胆红素水平。该委员会还确定了对遗传原因进行筛查的必要性，如G6PD缺乏症和先天性甲状腺功能减退症，如果出现这些疾病，可能会完全改变治疗方法。早期识别和开始治疗可预防急性胆红素脑病和核黄斑。目前，高胆红素血症的检测通常在护理时进行，但结果通常在患者出院后返回。G6PD和CH测试通常只有在患者对治疗没有反应时才进行。在这份提案中，我们描述了一种新技术，该技术有可能极大地简化测试过程，并加快测试结果的可用性。在这些新生儿疾病的诊断中，时间是至关重要的，因为通过及时的治疗可以防止严重的脑损伤。这项新技术需要的资源最少，成本低，适合在医院、门诊和农村社区使用。提供用于现场筛查的便携式和多路设备将能够对高危婴儿进行快速诊断。开发一种可以在护理点对常见新生儿疾病进行快速周转的多种分析的设备是开发现场便携式设备进行多重测试的第一步。与公众健康相关：Advanced Liquid Logic，Inc.正在其专有的数字(基于液滴)微流控平台上开发一种芯片实验室，用于临床诊断。拟议的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的新生儿(高胆红素血症)。该设备在快速识别和早期治疗方面将非常有用。

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.