摘要：本計畫旨在發展唾液快篩設備，包含唾液採集器、快篩試劑及自動判讀機，以達現場快速初篩之功能，提供警方緝毒及毒駕臨檢之執法利器及證據依據。由於警方在查緝吸毒者方面，目前均依靠尿液檢測，故無法執行現場快篩。而唾液及汗液檢測則是新興及可行方式，但考量到檢體採集之便利性及不易偽造等因素後，則以唾液檢體最具優勢。然而，唾液檢測在已實施之歐美各國間閾值相異，且國情、人種及飲食代謝等因素均我國不同，故其閾值須本土研訂，以適用於本計畫所開發之新型快篩設備。
閾值之研訂需大量本國吸毒者之檢體為統計基礎，且須針對各類毒品分別研訂，有鑑於目前醫療體系中此類檢體來源稀缺，而戒治所與保護管束中之毒犯均已被迫停藥，故最佳方式為透過警方平時查獲吸毒者之體液檢體進行收集。本計畫將由有長期與警政署合作收集尿液、DNA及指紋等生物資訊之警察大學負責，本計畫所需毒犯尿液及唾液檢體之取得，業經中央警察大學與警政署協調完畢，並將於初審通過後開始辦理。
本計畫將評估當前國內最常施用之海洛因(嗎啡、可待因)、安非他命、MDMA及愷他命等四類毒品，利用GC/MS及LC/MS進行定量，建立毒品代謝物在尿液及唾液中濃度的相關性，更進一步訂定出唾液中各類藥毒品的閾值，並以免疫分析法搭配不同的顯像粒子。除改良現有方法外，更將合成奈米金粒子與修飾表面官能基，開發奈米金化學官能基修飾法之感測器，以期提昇檢測之準確性與快速性，最終將研發出精準、快速之快篩試劑。
本計畫為提昇警方現場判讀之正確性，以及降低執勤現場之爭議性，將同步開發便利而安全之唾液採集器及高效而輕巧之自動判讀機，並研訂標準作業流程，以利緝毒與取締毒駕之執行。所開發之試劑及快篩設備將委託廠商進行開模製作，將所開發技術商品化。
Abstract: The project aims to develop a fast testing device—a saliva collector, test kit and reading device—for initial drug screening of saliva samples, which can provide the legal basis for the roadside law enforcement. The current practice in the anti-drug investigation adopted by the police is the urine drug testing, which does not allow for fast, on-site screening. Other bio fluids such as oral fluid or sweat also show great potentials as the alternative specimens in drug detection. Among them, oral fluid is easy to obtain noninvasively and contains many analytes of interest that correspond to the findings in blood. Therefore, oral fluid has grown increasingly popular in detecting drug use in the US and Europe. However, the domestic studies regarding the saliva drug testing in humans remain scarce and the cut-off values adopted by other countries cannot directly apply to Taiwanese residents due to differences in culture, ethnicity, diet and metabolism, etc. To make the drug saliva testing a feasible tool in Taiwan, it is imperative to determine the appropriate cut-off values to be applied in the developed new device.
The determination of cut-off values requires a large amount of local specimens for each illicit drug. Such specimens in the current health care system or rehab centers are insufficient, as drug users in custody have often been forced to stop using. Consequently, the best way to collect bio-fluid samples is through the police system. Our team members in Central Police University, has gained support from the National Police Agency regarding the collection of urine and saliva samples. Upon approval of this proposal, the Central Police University team will proceed with the required paperwork and sample collection.
In this project, we will focus on four major categories of drugs, including heroin (morphine and codeine), amphetamine, MDMA and ketamine. To establish the correlation between the drug concentrations in saliva and urine samples, both samples will undergo confirmatory quantification via GC/MS and LC/MS. Subsequently the immunochemical analysis will be carried out with the suggested cut-off values for the device testing and reagent quantity optimization. In addition to developing a cheaper, faster screening test kit, we will synthesize gold nanoparticles (AuNPs) and modify AuNPs’ surface with functional groups to develop a new detection technology for enhancing the sensitivity and improving the detection limit.
To enhance the accuracy and avoid controversy in police checkpoints, we will develop a compact and user-friendly digital test kit reader. In accord with our prototype design, we will also draft the standard operating procedure to facilitate the anti-drug investigation and roadside tests of drivers under the influence of a drug. Ultimately, the developed prototyped saliva collector, test kit and device will be contracted for manufacturing and commercialization.
