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）：一种用于检测γ-羟基丁酸（GHB）（被称为约会强奸药物）的简单易用的尿液试纸条，是通过利用γ-羟基丁酸脱氢酶的特定酶法开发的。酶试剂极其不稳定，但我们的一期研究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）将测试条的室温储存稳定性提高到至少12个月，（2）扩大测试条生产工艺，（3）开发一个点-用于医院环境的护理数字阅读器，以及（4）评估 GHB 检测系统的性能并为 III 期临床试验做好准备。在成功完成 II 期研究后，我们预计将有一种可供医院急诊室使用的尿液试纸，其检测时间为两分钟，检测限至少为 0.05 mg/mL GHB，且呈蓝紫色。所开发的测试条的颜色可以通过小型数字读取器读取，该读取器能够将其数据传输到医院数据管理计算机。拟议的 GHB 测试条还可在室温下稳定至少 12 个月，无需任何特殊的储存条件。制造这些测试条的生产工艺也将得到开发，以实现每次运行超过 500 个测试条的生产速度。较高的制造速度将积累第三阶段临床试验所需的试纸库存。 /相关性 该项目的开展是因为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且快速的检测方法来评估昏迷状态的患者。目前，唯一可用的方法是 GC/MS 和 CAT 扫描，这些方法价格昂贵且需要 1-4 小时才能完成。除了 ER 应用之外，拟议的 PortaGHB 测试系统还具有潜在的执法应用。该产品的估计潜在市场每年超过 7000 万美元。