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: 10845933
• 负责人: Md Mezbah Uddin
• 金额: $ 14.98万
• 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/10845933
• 关键词: 2019-nCoV; Accident and Emergency department; Accounting; Affinity; Antibodies; Antigens; B-Lymphocytes; Binding; Buffers; Cells; Centers for Disease Control and Prevention (U.S.); Cessation of life; Clinic; Clinical; Communication; Detection; Development; Disease Outbreaks; Drug Metabolic Detoxication; Emergency Situation; Enzyme-Linked Immunosorbent Assay; Epitopes; Eye; FDA approved; Family member; Fentanyl; Fluorescence-Activated Cell Sorting; Friends; Generations; Goals; Grant; Growth; Health Professional; Home; Human; Immunization; Individual; Lateral; Life; Liquid substance; Mammalian Cell; Marketing; Membrane; Messenger RNA; Monoclonal Antibodies; Naloxone; Nucleocapsid Proteins; Oral; Oryctolagus cuniculus; Overdose; Patients; Pennsylvania; Pharmaceutical Preparations; Pharmacotherapy; Phase; Process; Public Health; Rapid diagnostics; Running; Saliva; Sampling; Sensitivity and Specificity; Serum; Side; Site; Small Business Innovation Research Grant; Small Business Technology Transfer Research; Specificity; Substance Abuse Detection; Swab; System; Techniques; Technology; Testing; Time; Transfection; Universities; Urine; Validation; Viscosity; Visual; Work; analog; antibody detection; antigen binding; clinical care; clinically relevant; commercialization; cost; cross reactivity; detection limit; diagnostic screening; diagnostic tool; experience; fentanyl test; fentanyl use; fiberglass; illicit drug use; improved; instrument; lateral flow assay; migration; nanomolar; nanoparticle; opioid epidemic; point of care; point of care testing; portability; prevent; rapid test; response; saliva sample; salivary assay; screening; surfactant; test strip

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.

项目概要 芬太尼是导致阿片类药物流行的主要因素。快速识别致病药物。 因为芬太尼对于纳洛酮的及时和适当给药至关重要，并且适当的纳洛酮水平 从临床护理的角度来看，芬太尼的快速识别也是关键。 过量监测、疫情识别以及医疗保健专业人员之间的沟通。 全球即时（POC）药物滥用检测市场持续增长 全球非法药物使用（尤其是芬太尼及其衍生物）估计达 38 亿美元 到 2023 年，口服液药物滥用的复合年增长率 (CAGR) 将达到 5.4%。 到 2023 年，市场测试预计将达到 3880 万美元。然而，目前尚无 FDA 批准的药物 或在 POC 中批准芬太尼筛查的快速诊断 在这一阶段的 STTR 提案中， Instanosis Inc 将与宾夕法尼亚大学合作开发一种快速的药物并将其商业化 现场筛查诊断（sFENTANYL），可以部署在患者身边以快速 识别唾液中的芬太尼 在 sFENTANYL 中，使用拭子收集唾液，然后快速提取和提取。 应用于唾液侧流检测（sFENTANYL）试纸条，可有效检测0.1 ng/mL 5 分钟内即可用肉眼读出唾液中的芬太尼，无需外部辅助。 这种快速诊断工具满足 POC 芬太尼检测的临床需求： 快速、灵敏、便携且成本低，可用于多种设置，包括第一响应 车辆、急诊室、戒毒诊所、戒毒治疗诊所和病人之家。 在第一阶段，我们将开发具有所需分析灵敏度和读出时间的 sFENTANYL， 并使用去识别的临床唾液样本进行初步验证。