The performance of a point-of-care device, the OratectXP Oral Fluid Drug Screen Device for Ketamine, was evaluated. The cutoff specification for the device was for ketamine at 15 ng/mL. A total of 72 authentic oral fluid samples were collected from volunteers at two local rehabilitation centers for clients with addiction to drugs of abuse. These samples were tested with the device for visual detection of ketamine and also measured by a liquid chromatography isotope-dilution tandem mass spectrometry method for ketamine, norketamine and dehydronorketamine concentrations. Sensitivity of the device was 87.5% when tested by 24 authentic oral fluid samples with ketamine concentrations ≥ 15 ng/mL. False positive rate of the device was 4.5%. Specificity of the device was 97.9% when tested by 48 authentic oral fluid samples with ketamine concentrations < 15 ng/mL. False negative rate of the device was 6%. The overall efficiency of the device was 94%. According to the desirable acceptance criteria proposed by the "Driving Under the Influence of Drugs, Alcohol, and Medicines" project, the performance of the OratectXP was satisfactory and achieved the minimum standard for testing drivers under the influence of drugs. Furthermore, we propose the confirmation cutoff level for oral fluid ketamine to be at 25 ng/mL.

Lateral flow immunoassay devices offer many advantages including convenience, economical, simplicity, and rapid result. Many lateral flow immunoassays are non-instrumental and rely on visual detection of colored lines for results, enabling easy portability and allowing testing at any time and at any place by non-technical personnel. Hence, many lateral flow immunoassay tests have been developed for use ‘‘onsite’’, ‘‘point-of-care’’, or ‘‘point-of-test’’. However, utilization of this type of device requires the acceptance of some trade-offs. The most important is that the test results are generally qualitative. Moreover, since it is antibody-based, possibility exists that chemicals with similar structures will cause positive result leading to specificity and sensitivity issues. Recognizing such limitations, this technology has been widely utilized for screening tests in which a yes and no answer is sufficient. The initial screen test result can then be confirmed by a quantitative method, which is usually equipment-based and required the service of highly trained technician. Acceptance of this two-step procedure allows the massive testing of subjects economically and quickly without worrying about the test locations and the service of highly trained technician. An example of one such application is at home pregnancy testing in which a positive result would inevitably lead to a doctor’s visit for further testing. Another example is workplace drug testing in which positive result from a drug screen is confirmed by a laboratory GC/MS or LC/MS result. With the increasing popularity of lateral flow immunoassay devices, many users have ignored the inherent qualitative nature and specificity/ sensitivity issues of the assays and placed increasing demands on the manufacturers for fool-proof onsite tests. The present chapter examines this issue as exemplified by the false results encountered in abused drug screens. We shall first examine the definitions of positive and negative results in a

For the drug-testing industry, this is a time of new technologies and changes. There are various forms of lateral-flow devices making drug testing easier and providing results in matters of minutes. Test matrices other than urine are being investigated in which windows of detection can be narrowed to a few hours for detection of driving under the influence or be extended to several months to provide a long-term history of drug use. Moreover, information on drug testing is now widely available on the Internet, so that many more nonscientists are educated about drug testing. In this final chapter, we attempt to provide our personal thoughts on the industrial and scientific trends.

Oral fluids have been generating increased interest as a matrix for abused drug testing. The present chapter describes an oral-fluid on-site detection device, Oratect®, which screens for six drugs simultaneously. Oratect integrates collection, testing, and confirmation sampling into a single device. The collection process is simple, and test results can be obtained within 5 to 6 min. The data collected so far suggest that it is a viable screening test. Recently, the testing has been extended to alcohol, so that a simultaneous determination of drugs and alcohol is possible.

The use of commercial adulterants with the aim of defeating urine drug tests has become a growing problem for the drug-testing industry. Such products are easily available and act by substitution, dilution, and chemical adulteration. Regulatory guidelines to detect the presence of adulteration have been established. Several on-site adulteration test products are available. One of the widely used devices is Intect® 7 (Branan Medical Corporation), which is a dipstick covered with seven dry reagent pads that tests for creatinine, specific gravity, pH, nitrite, glutaraldehyde, bleach, and pyridinium chlorochromate. Intect 7 has been shown to detect all currently available commercial adulterants. For two oxidizing adulterants that appear to dissipate within a short period of time, Intect 7 was shown to be useful in detecting their presence on site.