Point-of-Care End-Tidal Carbon Monoxide Measurement to Screen for Sickle Cell Disease

床旁潮气末一氧化碳测量可筛查镰状细胞病

• 批准号: 8839680
• 负责人: Anish Bhatnagar
• 金额: $ 21.99万
• 依托单位: SOLENO THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-04-03 至 2015-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8839680
• 关键词: Accounting; Adult; Affect; Africa; Algorithms; Anemia; Antibiotics; Birth; Blood Tests; Blood specimen; Cannulas; Carbon Monoxide; Caring; Catabolism; Child; Country; Detection; Developing Countries; Devices; Diagnosis; Diagnostic tests; Disease; Early Diagnosis; Enrollment; Environment; Erythrocytes; Exhalation; Financial compensation; Gases; General Practices; Health education; Healthcare; Heme; Hemolysis; Hemolytic Anemia; High Prevalence; High temperature of physical object; Home environment; Hospitals; Human Resources; Humidity; Hydrogen; India; Infant; Inherited; Laboratories; Life; Live Birth; Measurement; Measures; Medical; Modeling; Modification; Monitor; Neonatal Screening; Newborn Infant; Nose; Output; Oxygen; Pediatric Hospitals; Performance; Phase; Populations at Risk; Porphyrins; Power Sources; Primary Health Care; Process; Public Health; Research; Research Infrastructure; Resources; Sampling; Sickle Cell Anemia; Signal Transduction; Small Business Innovation Research Grant; Solutions; Staging; System; Techniques; Technology; Temperature; Testing; Training; United States; Vaccination; Western Africa; abstracting; arm; base; commercial application; cost; design; disorder control; hemoglobin polymer; improved; infancy; innovation; mortality; point of care; point-of-care diagnostics; programs; prophylactic; public health relevance; screening; sensor; technological innovation; tool

 DESCRIPTION (provided by applicant): Sickle cell disease (SCD) is an inherited anemia in which formation of hemoglobin polymer causes destruction of the red blood cells, a process called hemolysis. SCD is recognized as a significant global public health problem. Over 90% of the 300,000 annual births with SCD occur in resource-poor countries, and most of the affected children die from preventable causes. Thus, there exists an urgent need for technologies to screen infants for SCD so that appropriate health care measures can be initiated. The aim of this proposal is to develop a robust point-of-care diagnostic system based upon measurement of breath carbon monoxide (CO) level. CO in exhaled breath is largely derived from the oxygen-dependent catabolism of heme during destruction of red blood cells, a process accelerated in SCD. Capnia has a device, CoSense", which is currently cleared by the FDA for End-Tidal Carbon Monoxide (ETCO) monitoring. The use of end-tidal breath samples allows the measurement of exhaled CO in young children who cannot provide a forced breath sample. A recent preliminary study demonstrated that ETCO levels measured by CoSense were 6-fold higher in SCD than the controls. Therefore, CoSense, as a screening tool, may be extremely helpful in identifying infants with SCD in resource-poor countries where newborn screening is not available. In Phase I of the SBIR proposal, the current device will be modified to extend its temperature operating range.

 描述（由申请人提供）：镰状细胞病（SCD）是一种遗传性贫血，其中血红蛋白聚合物的形成导致红细胞的破坏，这一过程称为溶血。SCD被认为是一个重要的全球公共卫生问题。每年30万名SCD新生儿中有90%以上发生在资源贫乏的国家，大多数受影响的儿童死于可预防的原因。因此，迫切需要筛查婴儿SCD的技术，以便可以启动适当的卫生保健措施。该提案的目的是开发一种基于呼吸一氧化碳（CO）水平测量的稳健的床旁诊断系统。呼出气中的CO主要来源于红细胞破坏过程中血红素的氧依赖性催化作用，这一过程在SCD中加速。Capnia有一种名为“CoSense”的设备，目前已被FDA批准用于监测潮气末一氧化碳（ETCO）。使用潮气末呼吸样本可以测量无法提供强制呼吸样本的幼儿呼出的CO。最近的一项初步研究表明，在SCD中通过CoSense测量的ETCO水平比对照高6倍。因此，CoSense作为一种筛查工具，在无法进行新生儿筛查的资源匮乏国家，可能对识别患有SCD的婴儿非常有帮助。在SBIR提案的第一阶段，将修改当前设备以扩展其温度工作范围。