ONTRAK TESTCUP: A Novel, On-Site, Multi-Analyte Screen for the Detection of Abused Drugs

Abstract

We developed a rapid, sensitive, and simple-to-use multi-analyte diagnostic device for the detection of drugs of abuse in urine: the ONTRAK TESTCUP. No sample or reagent handling is necessary with this device, and the device also serves as the sample collection cup. The TESTCUP contains immunochromatographic reagents that qualitatively and simultaneously detect the presence of benzoylecgonine, morphine, and cannabinoids (delta9-tetrahydrocannabinol [THC] in urine. It is based on the principle of competition between the drug in the sample and membrane- immobilized drug conjugate for antidrug antibodies coated on blue-dyed microparticles. Each drug assay has its own strip, which contains an antibody specific to benzoylecgonine, morphine, or THC. A sample is collected in the TESTCUP, a lid is placed on it, and a chamber at the top of the cup is filled with urine by inverting the cup for 5 s. Urine proceeds down immunochromatographic strips, and the assays are developed. In approximately 3-5 min, the Test Valid bars appear, a decal is removed from the detection window, and the results are interpreted. The appearance of a colored bar at the detection window for each drug indicates a negative result. The absence of color in any specific drug detection window indicates a positive result for that drug. If a positive result is obtained, the same device (cup) can be used for gas chromatographic-mass spectrometric (GC-MS) confirmation. When the precision of the TESTCUP was evaluated, the results obtained were as follows: for urine controls containing drug at 50% of its cutoff concentration, the results were greater than or equal to 96, 98, and 96% negative for benzoylecgonine, morphine, and THC, respectively; for urine controls containing drug at 120% of its cutoff concentration, the results were greater than or equal to 97, 100, and 98% positive for benzoylecgonine, morphine, and THC, respectively. The correlations of clinical sample results using the TESTCUP versus results by GC-MS and the ONTRAK and OnLine assays were assessed. There was 100% agreement between samples prescreened positive by GC-MS and positive by TESTCUP for all three assays. There was 100% agreement between TESTCUP and ONTRAK results and between TESTCUP and OnLine results when testing clinical samples positive and negative for cocaine (benzoylecgonine) or THC. Greater than 99% agreement was observed between TESTCUP and ONTRAK results and between TESTCUP and OnLine results when testing clinical samples positive and negative for morphine. The cross-reactivity of the TESTCUP assay to related drugs and drug metabolites was also determined, and the results were similar to those of the ONTRAK and OnLine assays.

Field test of on-site drug detection devices

“…Numerous studies have been published to assess the accuracy and reliability of on-site drug screening test devices (Buchan, 1997;Crouch, 1997;1998;Ferrara, 1994;Hwang, 1994;Koch, 1994;Towt, 1995). The basic design of many of these studies was similar to the study reported here.…”

“…Several studies have been performed to assess the sensitivity and selectivity of on-site testing devices (Fitzgerald, 1994;Wu, 1994;Koch, 1994;Baker, 1991;Armbruester, 1992;Ferrara, 1994;Jenkins, 1995;Towt, 1995). Unfortunately, these studies have been performed primarily in laboratories using trained laboratory professionals and have compared a single onsite drug test device to laboratory based immunoassay tests such as Enzyme Mediated…”

Frontline ® immunochromatographic device for on-site urine testing of amphetamines: laboratory validation using authentic specimens

“…However, other studies have given better results, and both equivalent and superior results to laboratorytest measurementshave been reported. 3,5,8 Nonetheless, one comprehensive study demonstrated somewhat lower ef®ciency of on-site test devices when compared with techniques used by professional laboratories. 4 …”

Évaluation de tests de dépistage des drogues sur le terrain

“…Celles-ci sont issues entre autres d'un récent rapport sur l'exactitude et la facilité d'emploi des tests de terrain publié par le Dr. Dennis J. Crouch (Center for Human Toxicology, University of Utah, Salt Lake City), d'évaluations publiées dans diverses revues internationales (5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19)(20), de posters présentés lors de congrès internationaux, de rapports internes fournis par les fabricants et distributeurs ainsi que de données disponibles sur le réseau Internet.…”