2016 ANNUAL REVIEW Ministry of Science and Technology

(3) Development of rapid testing technology for ketamine Motivated by the increasingly severe abuse of various types of new drugs in Taiwan, and a wish to remedy the current lack of an on-site rapid drug screening instrument, a research team from the Department of Engineering Science, National Cheng Kung University completed development of a prototype portable saliva ketamine quantitative testing instrument. The use of this instrument requires subjects to hold a saliva collector in their mouths for only 1-3 minutes, after which the saliva specimen is dripped into reagent in the fast-screening instrument; the instrument can automatically complete readings within 5 minutes. Apart from being able to determine a positive or negative reaction for ketamine, the instrument can also display the ketamine concentration, and it has a testing precision of over 90%. A desktop version of the instrument has received a Class 1 medical equipment license from the Ministry of Health and Welfare. Specimen collection and interpretation time is 10 min., and the lowest measurable concentration of ketamine is 25 ng/ml. At the same time, a research team from the Department of Bio-industrial Mechatronics Engineering, National Taiwan University has also developed a saliva rapid screening system for ketamine. The testing method employed by this system involves the use of a new type of gold nanoparticle, which serves to increase sensitivity and detection limit. The team's research results can be extended to many-in-one drug reagent cassettes, and the system can display drug metabolite test results in digital form. This system can be used for direct, rapid testing during traffic stops and in other situations. The readers developed by the two teams both rely on commercial antibody reagents to ensure testing consistency. To compare the systems with saliva specimen testing instruments currently on the market, a research team affiliated with China Medical University Hospital and Taipei Veterans General Hospital performed clinical saliva ketamine testing. Analysis performed at China Medical University Hospital revealed that the instruments developed by the research teams achieved an accuracy of over 90%, which complies with the minimum standard prescribed by medical equipment clinical trial laws (which require that both sensitivity and specificity be higher than 80%). The automatic ketamine readers developed by the two teams offer the advantages of objective interpretation and reading results that are not affected by ambient lighting and changes in operators. In view of the fact that clinical testing results have indicated that there are good correlations between urine ketamine concentration and saliva test results, it will be very feasible for police units to perform saliva testing of suspected users of ketamine or other drugs when conducting traffic stops. Use of system in actual testing Source: Research team under Prof. Chiang Hui-hua of National Yang Ming University Upper row: Normal eyes display an even temperature decrease, and the tear film remains stable and unbroken. Lower row: Dry eyes display an irregular temperature decrease, and the tear film is broken and unstable (one-second interval between frames). Source: Research team of Prof. Lin Yu-cheng, National Cheng Kung University Desktop testing instrument Handheld quantitative drug testing instrument Support for Academic Research Ministry of Science and Technology 35