Point of Care Breath Test to Screen for Sickle Cell Disease in Developing Nations

用于筛查发展中国家镰状细胞病的护理点呼吸测试

• 批准号: 9346344
• 负责人: Anish Bhatnagar
• 金额: $ 105.73万
• 依托单位: SOLENO THERAPEUTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-08-21 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9346344
• 关键词: Adoption; Affect; Age; Blood Tests; Blood specimen; Breath Tests; Cannulas; Carbon Monoxide; Characteristics; Child; Clinical; Clinical Trials; Community Healthcare; Comorbidity; Coupled; Cross-Sectional Studies; Data; Day center care; Developing Countries; Devices; Disease; Early Diagnosis; Electrophoresis; Ensure; Family; Fetal Hemoglobin; Focus Groups; G6PD gene; Genetic; Goals; Guidelines; Health Personnel; Healthcare; Hemoglobin; Hemolysis; Industry; Infant; Instruction; Laboratories; Language; Malaria; Measurement; Measures; Medical Device; Minor; Modification; Monitor; Neonatal; Nigeria; Nigerian; Nose; Performance; Protein Isoforms; Protocols documentation; Random Allocation; Reading; Regimen; Resources; Sampling; Sensitivity and Specificity; Sickle Cell Anemia; Sickle Hemoglobin; Testing; Time; Training; Tropical Climate; Work; base; care systems; design; field study; graphical user interface; improved; mortality; neonate; novel; point of care; portability; sample collection; screening; skills; tool; usability

SUMMARY More than 300,000 babies are born annually with sickle cell disease (SCD), 90% of which occur in developing countries, with the largest number in Nigeria. A majority of children with SCD die before 5 years, but when early SCD screening is coupled with health care management, mortality can be reduced dramatically. Unfortunately, because universal screening requires blood samples from infants, it is rarely done in resource-limited settings where it is expensive and hard to implement. A simple, economical and portable point-of-care (POC) screening test that is well accepted by families, avoids the need for blood sampling, and is easily integrated into the existing community health care system without diverting time and resources from other healthcare priorities is critically needed. To this end, Capnia has modified the portable CoSense End Tidal Carbon Monoxide (ETCO) Monitor to make it suitable for point of care use as a SCD screening tool in tropical climates. The monitor non-invasively measures carbon monoxide in breath, a byproduct of hemolysis, and clearly distinguishes between children with or without SCD. Because measurements can be made without a forced breath sample, it is suitable for use in infants and young children who cannot reliably follow sample collection commands. Further, the only disposable item required is an inexpensive nasal cannula. Thus, this simple-to-use device meets all of the desirable characteristics for use as a SCD screening tool in low resource settings. In order to fully prepare the device and develop an SCD screening regimen for commercial deployment we propose four aims. In Aim 1 we will determine the optimal age at which infants should be screened using ETCO and a recommended ETCO threshold at which they should be referred for further SCD. We will also define the sensitivity and specificity of detecting SCD in Nigerian children. In Aim 2 we will enhance the usability of CoSense-S to make it suitable for field use in Nigeria and develop training materials to support its commercial deployment for SCD screening. Work in Aim 3 will test the reliability and ease of use of CoSense-S in field conditions in Nigeria. Our goal is to test and validate the modified monitor, CoSense-S, for SCD screening in the field in Nigeria. If successful, we will be ready to commercialize a device that will for the first time make widespread screening for SCD feasible in low resource settings.

总结 每年有30多万婴儿出生时患有镰状细胞病（SCD），其中90%发生在 在发展中国家，人数最多的是尼日利亚。大多数患有SCD的儿童 5年前死亡，但当早期SCD筛查与医疗保健管理相结合时， 死亡率可以大大降低。不幸的是，由于普遍筛查需要 婴儿的血液样本，很少在资源有限的环境中进行，因为它是昂贵的 很难实施。简单、经济且便携的护理点（POC）筛查测试 这是很好的家庭接受，避免了血液采样的需要，并很容易集成 现有的社区卫生保健系统，而不转移时间和资源， 迫切需要其他保健优先事项。为此，Capnia对便携式 CoSense潮气末一氧化碳（ETCO）监测仪，使其适合床旁使用 作为热带气候下的SCD筛查工具。该监测仪以非侵入性方式测量碳 呼吸中的一氧化碳，溶血的副产品，并明确区分儿童与 或者没有SCD。因为测量可以在没有强制呼吸样本的情况下进行，所以 适用于不能可靠地跟踪样本采集的婴幼儿 命令.此外，唯一需要的一次性物品是廉价的鼻插管。因此，在本发明中， 这种使用简单的设备满足了用作SCD筛选的所有期望特性 低资源设置中的工具。为了充分准备设备并开发SCD筛选 对于商业部署，我们提出了四个目标。在目标1中，我们将确定 使用ETCO和推荐的ETCO筛查婴儿的最佳年龄 阈值时，应将其转介至进一步SCD。我们还将定义灵敏度 和尼日利亚儿童SCD检测的特异性。在目标2中，我们将增强 CoSense-S，使其适合尼日利亚的实地使用，并编写培训材料，以支持 用于SCD筛查的商业部署。目标3中的工作将测试 在尼日利亚的田间条件下使用CoSense-S。我们的目标是测试和验证修改后的 在尼日利亚的现场进行SCD筛查的CoSense-S监测仪。如果成功，我们将准备好 将一种首次对SCD进行广泛筛查的设备商业化 在低资源环境下可行。