A Lateral Flow Assay for Rapid Saliva Fentanyl Detection (sFENTANYL)

用于快速唾液芬太尼检测的侧流分析 (sFENTANYL)

• 批准号: 10388804
• 负责人: Md Mezbah Uddin
• 金额: $ 25.66万
• 依托单位: INSTANOSIS, INC.
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-01 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10388804
• 关键词: Accident and Emergency department; Biological Assay; Clinic; Clinical; Clinical Sensitivity; Cocaine; Communication; Detection; Disease Outbreaks; Drug Metabolic Detoxication; Eye; FDA approved; Fentanyl; Goals; Gold; Growth; Health Professional; Heroin; Home; Individual; Legal patent; Liquid substance; Methods; Naloxone; Oral; Overdose; Patients; Pennsylvania; Performance; Pharmaceutical Preparations; Pharmacotherapy; Phase; Public Health; Rapid diagnostics; Residual state; Saliva; Sampling; Sensitivity and Specificity; Side; Small Business Technology Transfer Research; Substance Abuse Detection; Swab; Technology; Testing; Time; Universities; Validation; Visual; analog; clinical care; cost; diagnostic screening; diagnostic tool; illicit drug use; improved; instrument; lateral flow assay; opioid epidemic; point of care; portability; rapid test; response; saliva sample; screening

Project Summary Fentanyl is a major contributor to the Opioid Epidemic. Rapid identification of the causative drug as fentanyl is critical for prompt and appropriate administration of naloxone, and the right level of clinical care. From the public health perspective, rapid identification of fentanyl is also key to overdose surveillance, outbreak recognition and communication among healthcare professionals. The global market for point-of-care (POC) drug of abuse testing, fueled by the continued growth of illicit drug use worldwide, especially fentanyl and its derivatives, is estimated to be $3.8 billion in 2023, growing at a compound annual growth rate (CAGR) of 5.4%. Oral fluid drugs of abuse testing market is estimated at $38.8 million in 2023. However, there is currently no FDA-approved or cleared rapid diagnostic for fentanyl screening at the POC. In this phase I STTR proposal, Instanosis Inc will partner with University of Pennsylvania to develop and commercialize a rapid onsite screening diagnostics (sFENTANYL) that can be deployed at the patient’s side to quickly identify fentanyl in saliva. In sFENTANYL, saliva is collected using swabs, quickly extracted and applied to the saliva lateral flow assay (sFENTANYL) strip that can effectively detect 0.1 ng/mL fentanyl in saliva within 5 min. Readout is visual with naked eyes, with no need for external instruments. This rapid diagnostic tool meets the clinical needs of fentanyl detection at the POC: rapid, sensitive, portable and low cost, and can be used in many settings, including first response vehicles, emergency departments, detoxification clinics, drug treatment clinics and patient homes. In Phase I, we will develop sFENTANYL with the needed analytical sensitivity and readout time, and conduct preliminary validation using deidentified clinical saliva samples.

项目摘要 芬太尼是阿片类药物流行的主要贡献者。快速识别因果药 因为芬太尼对于迅速和适当的纳洛酮至关重要，并且适当的水平 临床护理。从公共卫生的角度来看，芬太尼的快速识别也是 医疗保健专业人员之间的过量监视，爆发认可和沟通。 由持续增长推动的全球护理点（POC）药物（POC）药物 全球非法药物使用，尤其是芬太尼及其衍生物，估计为38亿美元 2023年，以复合年增长率（CAGR）为5.4％的增长。口服滥用药 测试市场在2023年估计为3880万美元。但是，目前尚无FDA批准 或清除了在POC处进行芬太尼筛查的快速诊断。在这个阶段，我的sttr提案， Intanisosis Inc将与宾夕法尼亚大学合作开发和商业化快速 现场筛查诊断（Sfentanyl）可以在患者方面部署以迅速部署 识别唾液中的芬太尼。在sfentanyl中，使用拭子收集唾液，快速提取并 应用于可以有效检测0.1 ng/ml的唾液侧向流量测定法（Sfentanyl）条 芬太尼在5分钟内在唾液中。读数是视觉的，裸眼，不需要外部 乐器。这种快速的诊断工具满足POC芬太尼检测的临床需求： 快速，敏感，便携式和低成本，可以在许多情况下使用，包括第一回应 车辆，急诊科，解毒诊所，药物治疗诊所和患者家庭。 在第一阶段，我们将以所需的分析灵敏度和读数时间开发sfentanyl， 并使用去识别的临床唾液样品进行初步验证。