Development of a Point-Of-Care Test for Determining Bilirubin in Whole Blood

开发测定全血中胆红素的即时测试

• 批准号: 7611564
• 负责人: Wai Tak Law
• 金额: $ 11.91万
• 依托单位: PORTASCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-01-15 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7611564
• 关键词: Academy; Acids; Address; Affect; Age; American; Bedside Testings; Bilirubin; Birth; Blood; Blood specimen; Brain Injuries; Caregivers; Cellulose; Cessation of life; Clinical Practice Guideline; Development; Dose; Dyes; Erythrocytes; Glucose; Goals; Guidelines; Hand; Heel; Hospitals; Hour; Hyperbilirubinemia; Infant; Kernicterus; Laboratories; Length of Stay; Life; Measurement; Membrane; Modeling; Neonatal; Newborn Infant; Nylons; One-Step dentin bonding system; Patients; Pediatrics; Performance; Phase; Physicians; Pluronics; Polymers; Polyvinyl Alcohol; Polyvinyls; Process; Pyrrolidinones; Quality of life; Reading; Reagent; Reporting; Risk; Running; Sampling; Serum; Sodium Chloride; Solid; System; Test Result; Testing; Time; Toluidines; Triton; Whole Blood; base; hearing impairment; high risk; hydrophilicity; meter; minimally invasive; neonatal hyperbilirubinemia; nitrobenzene; prototype; public health relevance; response; surfactant; total measurement Bilirubin

DESCRIPTION (provided by applicant): Neonatal hyperbilirubinemia (excessive bilirubin) is one of the most common problems encountered in newborns. If caught in time, hyperbilirubinemia can be treated. In a newborn infant, severe hyperbilirubinemia can cause brain damage (kernicterus), hearing loss, physical abnormalities, and even death. Recently, there has been a re-emergence of kernicterus, a preventable brain injury resulting from severe neonatal hyprbilirubinemia. This is due to early discharge after delivery, inaccurate bilirubin measurements, and improper management of the patients [2]. The average hospital stay for a newborn delivered vaginally in 1970 was 3.9 days; today the average hospital stay is 1.7 days. Newborn bilirubin levels, however, do not peak until sometime between the third and fifth day after birth [6]. With early discharge, the opportunity and responsibility for observing the newborn during the period with the greatest risk of extreme hyperbilirubinemia has shifted from the hospital to the primary caregiver. The American Academy of Pediatrics (AAP) revised their clinical practice guidelines for managing hyperbilirubinemia in 2004. The new guidelines recommend that all bilirubin levels be interpreted according to the infant's age in hours [2]. Therefore, bilirubin test in newborns must be processed and reported urgently. Laboratories conducting testing may not be able to provide results in the relatively short time frame required for appropriate treatment decisions. This application proposes the development of a minimally invasive, inexpensive, point-of-care test that will provide the caregiver, both in the hospital and the office, direct and immediate access to whole blood total bilirubin levels. The test consists of a solid-phase test strip and reflectance based meter, similar to glucose models. The goal of the Phase I proposal is to determine the feasibility of building a functional prototype solid phase test strip. Phase I has five aims. Aim 1 is to identify a more suitable dye-substrate for the test. Aim 2 will focus on selecting membranes, stabilizers, and additives. Aim 3 will add a blood separation system to the test strip to allow for heel-stick samples. Aim 4 will build and test the initial prototype test strips. Aim 5 will start a stability study for the test strips. Phase II will continue the project by addressing how to handle small and special blood samples, couple the test strip with a hand-held meter, and continue to conduct performance and stability studies. PUBLIC HEALTH RELEVANCE: The proposed test strip will allow a physician to determine an infant's total bilirubin concentration from a whole blood sample without having to send out to a lab. With this information, the physician can identify and treat infants who are at high risk for bilirubin related conditions that are life threatening or that will adversely affect the quality of life.

描述（由申请人提供）：新生儿过度胆红素血症（过度胆红素）是新生儿遇到的最常见问题之一。如果及时捕获，可以治疗高胆红素血症。在新生婴儿中，严重的高胆红素血症会导致脑损伤（内核），听力损失，身体异常甚至死亡。最近，内核重新出现了，这是严重的新生儿杂脂蛋白血症导致的可预防的脑损伤。这是由于分娩后提早出院，胆红素的测量不正确以及患者的治疗不当[2]。 1970年阴道分娩的新生儿的平均住院时间为3.9天；今天，平均住院时间为1.7天。但是，新生儿胆红素水平直到出生后的第三天到第五天之间的某个时候才达到顶峰[6]。随着早期出院，在此期间观察新生儿的机会和责任是最大的高胆红素血症的最大风险，已经从医院转移到了主要护理人员。 美国儿科学会（AAP）修订了其管理的临床实践指南 2004年的高胆红素血症。新指南建议根据婴儿年龄在小时内根据婴儿的年龄来解释所有胆红素水平[2]。因此，必须对新生儿中的胆红素测试进行处理和紧急报告。进行测试的实验室可能无法在适当的治疗决策所需的相对较短的时间范围内提供结果。 该申请提出开发最低少，廉价的护理测试，该测试将为医院和办公室提供护理人员，直接并直接进入全血胆红素总水平。该测试由固相测试条和基于反射率的仪表组成，类似于葡萄糖模型。 I期建议的目的是确定构建功能原型固相测试条的可行性。第一阶段有五个目标。 AIM 1是确定更合适的染料底物进行测试。 AIM 2将专注于选择膜，稳定器和添加剂。 AIM 3将在测试条中添加血液分离系统，以允许脚跟粘样样品。 AIM 4将构建和测试初始原型测试条。 AIM 5将开始对测试条的稳定研究。 第二阶段将通过解决如何处理小型和特殊的血液样本，将测试条与手持仪表搭配并继续进行性能和稳定研究来继续该项目。 公共卫生相关性：拟议的测试条将允许医生从全血样品中确定婴儿的总胆红素浓度，而无需发送给实验室。有了这些信息，医生可以识别和治疗与胆红素相关的疾病高风险的婴儿，这些疾病危及生命或会对生活质量产生不利影响。