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

SBIR第一阶段项目旨在改变疟疾感染者的治疗方案。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，仍然是生活在感染风险中的28.5亿人中的发病率和死亡率的潜在原因。目前可用于间日疟原虫和卵形疟原虫治疗的唯一药物是伯氨喹，其可在葡萄糖-6-磷酸脱氢酶（G6 PD）缺乏的个体中引起危及生命的贫血。临床医生通常不开伯氨喹，因为出生时患有G6 PD缺乏症的人患病率很高（8%）。世界卫生组织（WHO）和卫生适当技术计划（PATH）正在紧急寻找一种可靠的G6 PD缺乏症诊断方法，以有效治疗患者并帮助根除间日疟原虫和卵形疟原虫疟疾。这种新的检测方法将定量G6 PD和血红蛋白（Hgb）浓度同时从手指针刺样品。该系统包括一个单一的测试条与反射率为基础的米和手机应用程序与蓝牙连接，以纳入一个病人？身份证，测试结果、全局跟踪和治疗史。据预测，这种即时检测将在推出后的5年内用于筛查2300万人的G6 PD，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检测平台，可用于目前无法使用即时检测方法的美国患者的其他疾病或病症。所提出的新型平台将使用即时检测（POC）从单个手指针刺样本中同时定量葡萄糖-6-磷酸脱氢酶（G6 PD）和血红蛋白（Hgb）浓度基于反射率的仪表。目前市场上还没有这种设备，迫切需要这种设备来筛查正在接受治疗的间日疟原虫和卵形疟原虫疟疾患者。世界人口中有很大一部分（8%）是G6 PD缺乏症，这使得这些人在使用目前的治疗药物（如伯氨喹）治疗疟疾后面临危及生命的贫血风险。POC检测利用新型裂解和试剂层膜平台，使基于反射率的测量仪能够测量非重叠波长，以定量G6 PD和Hgb浓度。在这项建议中，一个功能原型反射率为基础的米和数据收集软件将被构造和比较使用当前？黄金标准？柯尼卡美能达分光光度计。其次，将使用适当卫生技术计划（PATH）提供的G6 PD缺陷型全血标本库，通过性能检测对POC检测试剂盒进行验证。将从20份样本中获得的用于拟定测定的数据的一致性与世界卫生组织的一致性进行比较。s（WHO）批准的用于测量G6 PD的分光光度法和FDA批准的用于测量Hgb的方法。成功将通过R2 0.95表示，这证明了线性等效性，并证明90%的数据点在每个值的2 sigma范围内。一种可以同时筛查患者G6 PD缺乏症和Hgb水平的POC检测方法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。

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.