A Rapid and Sensitive Test for Gamma-hydroxybutyrate

快速、灵敏的 γ-羟基丁酸测试

• 批准号: 7407493
• 负责人: Wai Tak Law
• 金额: $ 35.26万
• 依托单位: PORTASCIENCE, INC.
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-01-15 至 2009-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7407493
• 关键词: 4-hydroxybutyrate dehydrogenase; Accident and Emergency department; Biological Assay; Clinical Trials; Color; Coma; Computers; Condition; Data; Detection; Devices; Diagnostic; Emergency Situation; Equipment and supply inventories; Forcible intercourse; Hospitals; Hour; Hydroxybutyrates; Law Enforcement; Liquid substance; Marketing; Methodology; Methods; Optics; Patients; Performance; Pharmaceutical Preparations; Phase; Phase I Clinical Trials; Phase II Clinical Trials; Physicians; Process; Production; Rate; Reader; Reading; Reagent; Research; Running; Solid; Speed; System; Temperature; Testing; Time; Urine; Vendor; Work; X-Ray Computed Tomography; base; data management; digital; gamma hydroxybutyrate; improved; manufacturing process; point of care; prototype; scale up

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.

描述（由申请人提供）：正在开发一种用于检测γ-羟基丁酸（GHB）（称为枣椰药）的简单易用的尿液试纸，该试纸采用了一种利用γ-羟基丁酸脱氢酶的特定酶法。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形式转化为相对稳定的固相试纸形式的可行性。在拟议的第二阶段研究中，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）扩大试纸生产工艺，（3）开发用于医院环境的即时数字阅读器，以及（4）评价GHB测定系统的性能并为第三阶段的临床试验做准备。在第二阶段研究成功完成后，我们预计将有一个尿液测试条可用于医院急诊室，其分析时间为两分钟，检测限至少为0.05 mg/mL GHB，并且开发的测试条的蓝紫色颜色可以通过小型数字阅读器读取，该阅读器能够将其数据传输到医院数据管理计算机。拟议的伽马--羟丁酸试纸条在室温下至少可稳定保存12个月，无需任何特殊储存条件。还将开发制造这些测试条的生产工艺，以使每次运行的生产速度超过500个测试条。更高的生产率将积累III期临床试验所需的试纸库存。14.开展该项目是因为迫切需要一种能够快速检测体液中γ-羟基丁酸的诊断试剂盒。急诊室医生需要一种可靠和快速的检测方法来评估处于昏迷状态的患者。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小时来执行。除了ER应用外，拟议的PortaGHB测试系统还具有潜在的执法应用。该产品的潜在市场估计每年超过7 000万美元。