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

这个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和卵形疟原虫引起的疟疾，仍然是28.5亿面临感染风险的人发病和死亡的潜在原因。目前可用于治疗间日疟原虫和卵形疟原虫的唯一药物是伯氨喹，它可以在葡萄糖-6-磷酸脱氢酶(G6PD)缺乏症患者中导致危及生命的贫血。由于先天G6PD缺乏症的高患病率(8%)，临床医生通常不开伯氨喹。世界卫生组织(WHO)和卫生适宜技术计划(PATH)正在紧急寻找一种可靠的G6PD缺乏症诊断方法，以有效地治疗患者并帮助根除间日疟和卵形疟。这一新提出的分析方法将从手指棒样本中同时定量G6PD和血红蛋白(HGB)浓度。该系统包括一个单一的测试条、一个基于反射率的测量仪和带有Blue Tooth连接的手机应用程序，将患者S的身份、检测结果、全球跟踪和治疗历史结合在一起。据预测，这种护理点检测方法将在推出后5年内用于对2300万人进行G6PD筛查，并产生超过2750万美元的复合收入。从长远来看，新的分析方法将创建一个通用的护理点平台，可以用于影响美国患者的其他疾病或状况，目前还没有可用的护理点分析方法。拟议的新平台将使用基于护理点(POC)的反射率计从单个手指棒样本中同时定量葡萄糖-6-磷酸脱氢酶(G6PD)和血红蛋白(HGB)浓度。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间日疟原虫和卵形疟原虫治疗的患者。世界人口的很大一部分(8%)缺乏G6PD，这使这些人在接受目前的治疗方法(如抗疟疾伯喹)治疗后，面临威胁生命的贫血的风险。POC分析使用一种新型裂解和试剂层膜平台，使基于反射的仪器能够测量非重叠波长，以定量G6PD和HGB浓度。在这个方案中，将构建一个基于反射率的功能样机和数据采集软件，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缺陷全血标本库进行性能测试来验证。从20个样本获得的数据的一致性将与世界卫生组织S(世卫组织)批准的G6PD分光光度法和FDA批准的HGB测量方法进行比较。成功将由R2 0.95表示，它表明线性等价，以及90%的数据点落在每个值的2西格玛范围内。一种可以同时筛查患者G6PD缺乏和HGB水平的POC测试将使临床医生能够有效地治疗感染间日疟原虫和卵形疟原虫的患者，并帮助根除疟疾。

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.