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.

概括 每年有超过30万婴儿出生于镰状细胞病（SCD），其中90％发生 在发展中国家，尼日利亚数量最多。大多数SCD儿童 在5年之前死亡，但是当早期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 来自婴儿的血液样本，很少在资源有限的环境中完成，在这些环境中很昂贵 并且很难实施。一个简单，经济和便携式护理（POC）筛查测试 这是家庭所接受的，避免需要进行血液采样，并且很容易整合 进入现有的社区医疗保健系统，而无需转移时间和资源 需要其他医疗保健优先事项。为此，Capnia修改了便携式 COSENSE端潮汐碳一氧化碳（ETCO）监视器适合使用点 作为热带气候中的SCD筛查工具。监视器非侵入性测量碳 呼吸中的一氧化碳，溶血的副产品，明确区分了 或没有SCD。因为可以在没有强迫呼吸样本的情况下进行测量，所以 适用于无法可靠遵循样本收集的婴儿和幼儿使用 命令。此外，唯一需要的一次性项目是廉价的鼻套管。因此， 这种易于使用的设备符合用作SCD筛选的所有理想特征 低资源设置中的工具。为了完全准备设备并开发SCD筛选 商业部署方案我们提出了四个目标。在AIM 1中，我们将确定 应使用ETCO和推荐的ETCO筛选婴儿的最佳年龄 应将其转介的阈值进一步scd。我们还将定义灵敏度 和检测尼日利亚儿童SCD的特异性。在AIM 2中，我们将增强 COSENSE-S使其适合于尼日利亚的现场使用并开发培训材料以支持 其商业部署用于SCD筛选。 AIM 3的工作将测试可靠性和易度 在尼日利亚的现场条件下使用COSENSE-S。我们的目标是测试和验证修改后的 监视尼日利亚现场的SCD筛选，监视器。如果成功，我们将准备好 商业化将首次对SCD进行广泛筛选的设备进行商业化 在低资源设置中可行。