PEDIATRIC SUB-MICROLITER BLOOD SAMPLING AND ASSAY

儿科亚微升血液采样和检测

• 批准号: 6214019
• 负责人: Wilson Harvey Smart
• 金额: $ 10万
• 依托单位: KUMETRIX, INC.
• 依托单位国家: 美国
• 财政年份: 2000
• 资助国家: 美国
• 起止时间: 2000-09-29 至 2001-03-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6214019
• 关键词: biomedical equipment development; blood tests; consumable /disposable biomedical equipment; hemoglobin; hypodermic needle; miniature biomedical equipment; optics; pediatrics; sample collection; serology /serodiagnosis; silicon

DESCRIPTION (Adapted from the Applicant's Abstract): In this first submission phase I proposal, the investigators propose to conduct the initial development of a device for performing hemoglobin measurements on pediatric patients. The major benefits of the proposed device are that it will be essentially painless, and that less than 1 microliter of blood is sampled. The proposed device will consist of a consumable sampling device that can be read in a hand held optical detector. The consumable sampling device will be made of an integrated silicon needle and curette with window. The components will be etched from silicon wafers using standard micro-fabrication techniques; the wafers are then bonded using high temperature fusion. When the blood is drawn through the needle into the curette, it will be hemolyzed by a detergent solution. The curette will then be inserted into the detector and the optical absorbance of oxy-hemoglobin, deoxy-hemoglobin, and methemoglobin will be measured using 3 light emitting diodes (LEDs). The concentrations of the 3 hemoglobin species will be determined by a microprocessor employing 3 simultaneous equations; the total hemoglobin concentration may then may calculated. There are 4 tasks proposed in Phase I. The first is to demonstrate a feasible hemoglobin assay based on the absorbance of light emitted from 3 LEDs with peak emission wavelengths at or near the absorbance peaks of the 3 hemoglobin species. The second is to design and fabricate experimental consumable sampling units. The third is to design and fabricate the test electro-optical instrumentation. The proposed instrument will use analog circuitry to manipulate the consumable unit to penetrate the skin and take a sample, retract it, to align the curette window with the optical system, to read the absorbance, and to calculate and display the resulting hemoglobin concentration. In the final task simultaneous measurements will be made on the test device and an unspecified commercial hemoglobin tester in order to determine the precision and accuracy of the test device. The investigators conclude that since the photometric method of hemoglobin concentration performs well with many different types of curettes, that a poor result from the test device would indicate problems specific to the micro-sampling technique. PROPOSED COMMERCIAL APPLICATION: The blood testing product that will emerge from this R & D program will be of particular benefit to pediatric patients because of its lack of pain and very small sample volume. Its ease of use will also make it attractive for home health care, nursing homes, and self- testing. In addition, rapid on-site measurement of methemoglobin will find application in occupation safety and health programs.

描述（改编自申请人摘要）：在此首次提交 第一阶段的建议，调查人员建议进行初步的发展， 用于对儿科患者进行血红蛋白测量的设备的一部分。的 所提出的装置的主要优点是它基本上是无痛的， 并且采集不到1微升的血液。所提出的装置将 由可在手持光学仪器中读取的消耗性取样装置组成， 检测器耗材取样装置将由集成硅制成， 带窗口的针和刮匙。这些组件将由硅蚀刻而成 使用标准的微制造技术的晶片;然后将晶片结合 使用高温熔化。当血液通过针头被抽到 刮匙会被清洁剂溶解刮匙将 然后插入检测器， 氧合血红蛋白、脱氧血红蛋白和高铁血红蛋白将使用3 发光二极管（LED）。3种血红蛋白的浓度 将由采用3个联立方程的微处理器确定; 然后可以计算总血红蛋白浓度。有四项任务 在第一阶段提出。第一个是证明一种可行的血红蛋白测定法 基于从具有峰值发射的3个LED发射的光的吸收 在3种血红蛋白物质的吸收峰处或附近的波长。的 二是实验耗材取样器的设计与制作。的 三是测试光电仪器的设计与制作。的 所提出的仪器将使用模拟电路来操纵消耗品单元 刺入皮肤并取样，将其撤回， 窗口与光学系统，读取吸光度，并计算和 显示结果血红蛋白浓度。在最后的任务中， 将在试验器械和未指明的市售器械上进行测量 血红蛋白测定仪，以确定试验的精密度和准确度 设备.研究人员得出结论，由于光度法的 血红蛋白浓度用许多不同类型的刮匙都能很好地进行， 测试设备的不良结果将表明特定于 微量取样技术 拟定商业应用： 从这个研发计划中产生的血液检测产品将是特别的， 因为它没有疼痛和非常小的样本体积，因此对儿科患者有益。 它的易用性也将使其对家庭医疗保健，养老院和自我护理具有吸引力。 试验.此外，高铁血红蛋白的快速现场测量将在职业安全和健康计划中得到应用。