SBIR Phase I: A user-friendly point-of-care device for simultaneous G6PDH and hemoglobin determination

SBIR 第一阶段：用户友好的即时检测设备，可同时测定 G6PDH 和血红蛋白

• 批准号: 1746309
• 负责人: Robert Harper
• 金额: $ 22.5万
• 依托单位: Analytical Diagnostic Solutions
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-01-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1746309&HistoricalAwards=false
• 关键词: SBIR; Phase; user; friendly; point

This SBIR Phase I project seeks to transform treatment regimens for individuals suffering from malaria infections. Malaria, particularly caused by Plasmodium vivax (P. vivax) and Plasmodium ovale (P. ovale) remain a potential cause of morbidity and mortality amongst the 2.85 billion people living at risk of infection. The only drug currently available for treatment therapy for P. vivax and P. ovale is primaquine, which can cause life-threatening anemia in individuals with glucose-6-phosphate dehydrogenase (G6PD) deficiency. Clinicians often do not prescribe primaquine due to the high prevalence (8%) of individuals who are born with G6PD deficiency. The World Health Organization (WHO) and the Program for Appropriate Technology in Health (PATH) are urgently searching for a reliable assay for the diagnosis of G6PD deficiency to effectively treat patients and aid in the eradication of P. vivax and P. ovale malaria. This novel assay proposed will quantify G6PD and hemoglobin (Hgb) concentration simultaneously from a finger stick sample. This system comprises a single test strip coupled with a reflectance-based meter and cell phone application with Blue Tooth connectivity to incorporate a patient?s I.D., test results, global tracking, and history of treatment. It is projected that this point-of-care assay will be used to screen 23 million people for G6PD within 5 years of launch and generate over $27.5 million in compounded revenue. In the long term, the novel assay will create a universal point-of-care platform that can be utilized for other diseases or conditions that affect patients in the Unites States for which point-of-care assays are not currently available.The proposed novel platform will quantify both Glucose-6-Phosphate Dehydrogenase (G6PD) and hemoglobin (Hgb) concentrations simultaneously from a single finger stick sample using a point-of-care (POC) reflectance-based meter. There is currently no such device on the market, which is urgently needed to screen patients being treated for P. vivax and P. ovale malaria. A significant portion (8%) of the world population is G6PD deficient, which places these individuals at risk for life-threatening anemia after treatment with current therapeutics such as primaquine against malaria. The POC assay utilizes a novel lysis and reagent layer membrane platform to enable a reflectance-based meter to measure non-over lapping wavelengths to quantify G6PD and Hgb concentrations. In this proposal, a functional prototype reflectance-based meter and data collection software will be constructed and compared to readings obtained using the current ?gold standard? Konica Minolta spectrophotometer. Secondly, the POC assay will be validated through performance testing using a G6PD-deficient whole blood specimen bank provided by the Program for Appropriate Technology in Health (PATH). Concordance of the data obtained from 20 samples for the proposed assay will be compared to the World Health Organization?s (WHO) approved spectrophotometric method for measuring G6PD and an FDA approved method for measuring Hgb. Success will be indicated by an R2 0.95, which demonstrates linear equivalency, as well as a demonstration that 90% of the data points fall within 2 sigma of each value. A POC assay that can simultaneously screen patients for both G6PD deficiency and Hgb levels will allow clinicians to treat patients with P. vivax and P. ovale malaria infections effectively and aid in the eradication of malaria.

该 SBIR 第一阶段项目旨在改变疟疾感染患者的治疗方案。疟疾，特别是由间日疟原虫 (P. vivax) 和卵形疟原虫 (P. ovale) 引起的疟疾，仍然是 28.5 亿面临感染风险的人发病和死亡的潜在原因。目前唯一可用于治疗间日疟原虫和卵形疟原虫的药物是伯氨喹，它可导致葡萄糖-6-磷酸脱氢酶 (G6PD) 缺乏症患者出现危及生命的贫血。由于出生时 G6PD 缺乏症的患病率很高 (8%)，临床医生通常不会开伯氨喹处方。世界卫生组织 (WHO) 和健康适当技术计划 (PATH) 正在紧急寻找一种可靠的检测方法来诊断 G6PD 缺乏症，以有效治疗患者并帮助根除间日疟原虫和卵形疟原虫。这种新颖的检测方法将同时量化指尖采血样本中的 G6PD 和血红蛋白 (Hgb) 浓度。该系统包括单个测试条、基于反射率的仪表和具有蓝牙连接的手机应用程序，以包含患者的 ID、测试结果、全局跟踪和治疗历史。预计该即时检测检测将在推出后 5 年内用于筛查 2300 万人的 G6PD，并产生超过 2750 万美元的复合收入。从长远来看，这种新的检测方法将创建一个通用的即时护理平台，可用于治疗影响美国患者的其他疾病或病症，而这些疾病或病症目前还没有可用的即时护理检测方法。该平台将使用基于即时护理 (POC) 反射率的仪表，同时对单个指尖采血样本中的葡萄糖-6-磷酸脱氢酶 (G6PD) 和血红蛋白 (Hgb) 浓度进行定量。目前市场上还没有这样的设备，迫切需要这种设备来筛查正在接受间日疟和卵形疟疾治疗的患者。世界人口中有很大一部分 (8%) 缺乏 G6PD，这使得这些人在使用伯氨喹等现有疗法治疗疟疾后面临危及生命的贫血的风险。 POC 测定利用新型裂解和试剂层膜平台，使基于反射率的仪表能够测量非重叠波长，以量化 G6PD 和 Hgb 浓度。在该提案中，将构建基于反射率的功能原型仪表和数据收集软件，并将其与使用当前“黄金标准”获得的读数进行比较。柯尼卡美能达分光光度计。其次，POC 检测将通过使用健康适当技术计划 (PATH) 提供的 G6PD 缺陷全血样本库进行性能测试来验证。将从拟议测定的 20 个样品中获得的数据的一致性与世界卫生组织 (WHO) 批准的用于测量 G6PD 的分光光度法和 FDA 批准的用于测量 Hgb 的方法进行比较。 R2 0.95 表示成功，它证明了线性等效性，并证明 90% 的数据点落在每个值的 2 sigma 范围内。可以同时筛查患者 G6PD 缺乏症和 Hgb 水平的 POC 检测将使临床医生能够有效治疗间日疟原虫和卵形疟原虫疟疾感染患者，并有助于根除疟疾。