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破坏，这一过程称为溶血。 SCD 被认为是一个重大的全球公共卫生问题。每年 30 万患有 SCD 的新生儿中，超过 90% 发生在资源匮乏的国家，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，以便采取适当的医疗保健措施。该提案的目的是开发一个基于呼吸一氧化碳 (CO) 水平测量的强大的护理点诊断系统。呼出气中的 CO 主要源自红细胞破坏过程中血红素的氧依赖性分解代谢，这一过程在 SCD 中加速。 Capnia 有一款名为“CoSense”的设备，目前已获得 FDA 批准用于潮气末一氧化碳 (ETCO) 监测。使用潮气末呼吸样本可以测量无法提供用力呼吸样本的幼儿呼出的 CO。最近的一项初步研究表明，CoSense 测量的 SCD 中的 ETCO 水平比对照组高 6 倍。因此，CoSense 作为一种筛查工具，可能对以下方面非常有帮助： 在无法进行新生儿筛查的资源匮乏国家中识别患有 SCD 的婴儿。在 SBIR 提案的第一阶段，将对当前器件进行修改以扩展其温度工作范围。