A Rapid and Sensitive Test for Gamma-hydroxybutyrate

描述（由申请人提供）：一种用于检测γ -羟基丁酸盐（GHB）的简单使用尿液试纸，该试纸被称为枣油菜药物，正在从利用γ -羟基丁酸脱氢酶的特定酶法开发。酶试剂非常不稳定，但我们的I期研究已经证明了将不稳定的液体试剂格式转换为相对稳定的固相测试条格式的可行性。在拟议的II期研究中，具体目标是(1)将试纸的室温储存稳定性提高到至少12个月，(2)扩大试纸生产流程，(3)为医院环境开发护理点数字读取器，以及(4)评估GHB检测系统的性能并为III期临床试验做准备。在成功完成II期研究后，我们期望医院急诊室可以使用尿液试纸，检测时间为两分钟，检测限至少为0.05 mg/mL GHB，并且开发的试纸的蓝紫色可以通过小型数字阅读器读取，该阅读器具有将其数据传输到医院数据管理计算机的能力。提议的GHB测试条还将在室温下稳定至少12个月，从而消除了任何特殊存储条件的需要。制造这些试纸条的生产工艺也将被开发，以允许每次运行超过500条试纸条的生产速度。较高的生产速度将增加III期临床试验所需的试纸库存。开展该项目的原因是迫切需要一种能够快速检测体液中γ -羟基丁酸盐的诊断试剂盒。急诊室医生需要一种可靠、快速的方法来评估昏迷状态的病人。目前，唯一可用的方法是GC/MS和CAT扫描，这是昂贵的，需要1-4小时的执行。除了ER应用之外，提议的PortaGHB测试系统也有潜在的执法应用。该产品的潜在市场估计每年超过7000万美元。

DESCRIPTION (provided by applicant): A simple -to-use urine test strip for detection of gamma-hydroxybutyrate (GHB)-known as the date rape drug-is being developed from a specific enzymatic method that utilizes gamma-hydroxybutyrate dehydrogenase. The enzymatic reagent is extremely unstable, but our Phase I studies have demonstrated the feasibility of converting the unstable liquid reagent format to a relatively stable solid-phase test strip format. In the proposed Phase II studies, the specific aims are (1) improve the room temperature storage stability of the test strips to at least 12 months, (2) scale-up the test strip production process, (3) develop a point-of-care digital reader for a hospital setting, and (4) evaluate the performance of the GHB assay system and prepare for clinical trials in Phase III. Upon the successful completion of the Phase II studies, we expect to have a urine test strip available for hospital emergency rooms that has an assay time of two minutes, has a detection limit of at least 0.05 mg/mL GHB, and the bluish-purple color of the developed test strip can be read by a small digital reader that has the capability transferring its data to a hospital data management computer. The proposed GHB test strip will also be room temperature stable for at least 12 months-eliminating the need for any special storage conditions. The production process for manufacturing these test strips will also be developed to allow a production speed of over 500 test strips per run. The higher manufacturing rate will buildup test strip inventory necessary for clinical trials in Phase III. /Relevance The project is being undertaken due to an urgent need for a diagnostic kit that can rapidly detect gamma- hydroxybutyrate in bodily fluids. Emergency room physicians have need of a reliable and rapid assay for evaluating patients that arrive in a comatose state. Currently, the only available methods are GC/MS and CAT scan, which are expensive and require 1-4 hours to perform. In addition to an ER application, the proposed PortaGHB test system also has potential law enforcement applications. The estimated potential market for this product is over $70 million per year.