A Comparative Evaluation of the Instant-View 5-Panel Test Card with OnTrak TesTcup Pro 5: Comparison with Gas Chromatography-Mass Spectrometry

Journal of Analytical Toxicology, Vol. 30, January/February 2006 [ TechnicalNote A Comparative Evaluationof the Instant-View5-Panel TestCard with OnTrak TesTcupPro 5: Comparisonwith Gas Chromatography-MassSpectrometry 1Center for Human Toxicology, Department of Pharmacology and Toxicology, University of Utah, Salt Lake City, Utah 84108 and 2Northwest Toxicology, Salt Lake City, Utah 84124 Abstract I This study comparedthe ability of two on-site testing devices, Instant-View Test Card and OnTrak TesTcupPro 5, to discriminate negative from positive urine samples for cannabinoids,cocaine metabolite, opiates, amphetamines, and benzodiazepines. The onsite devices were evaluated in a precision study with fortified urine samples and in a clinical study with samples submitted for forensic urine drug testing. For precision, seven stocks were prepared per device. Each stock had all five analytes added in a random fashion at 0, 25, 50, 75, 125, 150, or 175% of cutoff. Ten aliquots per stock were assigned random numbers and analyzed by two individuals. The respective accuracies (defined as "% below cutoff samples that were negative + % above cutoff samples that were positive") for Instant-View Test Card and TesTcup were 74.3 and 87.1 for amphetamines; 82.1 and 90.7 for benzoylecgonine; 88.6 and 90.7 for benzodiazepines; 83.6 and 94.3 for morphine; 82.1 and 87.9 for cannabinoids; and 82.1 and 90.1% overall. In contrast to the on-site testing devices, instrumental testing with OnLine reagents had perfect precision. For the clinical study, submitted samples that had reached their disposal date were rescreened for the five drug groups. Fifty that had absorbance changes near the negative control for all five drug groups were selected as 'negatives'; 240 samples with positive or multi-positive results (some between the 75% control and cutoff) and confirmed by GC-MS were chosen as 'positives' (at least 45 per drug group). The non-positive drug groups in these samples added = 150 additional presumptively negatives per drug group. Samples were assigned random numbers, and two individuals tested each sample. The respective accuracies in respect to GC-MS results for InstantView Test Card and TesTcup were 95.8 and 91.7 for amphetamines; 100 and 100 for benzoylecgonine; 96.7 and 96.5 for benzodiazepines; 98.8 and 99.2 for opiates; 94.4 and 95.0 for cannabinoids; and 97.1 and 96.5% overall. The clinical study revealed that the Instant-View Test Card had low cross-reactivity (i.e., false negatives) for samples with amphetamine only and oxycodone. TesTcup had low cross-reactivity for samples with * Author to whom correspondenceshould be addressed:David E. Moody, Ph.D., Universityof Utah, Centerfor Human Toxicology,417 WakaraWay, Suite2111, Salt LakeCity, UT 84108. E-mail: . 50 amphetamineonly and hydrocodoneand/or hydromorphone; it also had more cross-reactivitytowards (i.e., false positives) sympathomimeticamines. In summary,the Instant-View Test Card was lessprecisethan the TesTcup at or near the cutoff; with clinical samples, however, the percent accuracies of the two devices were similar. Introduction Urine drug testing is widely used in many areas of society to deter drug use and monitor compliance in drug treatment programs. Shipping of the specimen to centralized laboratories is time-consuming, and for some purposes, rapid determination of a drug-free urine sample can be considered critical. Over the past decade, a number of on-site (also known as pointof-care or point-of-collection) drug-testing devices have been developed (1,2). Most depend upon the principle of immunochromatography where a target analyte migrates along a chromatographic strip and competes for antibody at a specified location with a resultant loss or formation of a colored line. At this time we have evaluated the performance of a relatively new on-site testing device, the Instant-View 5 panel test card. The evaluation was performed to determine if the Instant-View test card would be suitable for use in monitoring compliance in clinical studies of anti-abuse medications. It was, therefore, formulated to test for cannabinoids, opiates, cocaine metabolite (benzoylecgonine), amphetamines, and benzodiazepines. The performance of the Instant-View test card was compared directly to the OnTrak TesTcup Pro 5 (TesTcup)on-site testing device that also monitors for the same five drug groups. The OnTrak TesTcup was chosen for comparative purposes because it has been the subject of a number of peer-reviewed studies (3), and in the Pro 5 version it could be formulated for the same five drug groups. Gas chromatography-mass spectrometry (GC-MS) was used for confirmation and quantitation of specific drugs or drug metabolites. Performance was evaluated in two Reproduction (photocopying) of editorial content of this journal is prohibited without publisher's permission. David E. Moody 1,*, Wenfang B. Fang 1, David M. Andrenyak 1, Kim M. Monti 1, and Chuck Jones2 Journal of Analytical Toxicology, Vol. 30, January/February 2006 parts, a precision study where addition of analytes at 0-175% of cutoffs was made in a random manner and analysts were blind to the contents and a clinical study where submitted samples were chosen to provide negative, near-cutoff, and positive samples. Materials and Methods Immunoassay procedures In the precision study, different test samples were prepared for each device. During a precision testing session, only one type of device was evaluated (10 devices of the one type, five prepared by each analyst). During the clinical study, where each sample was analyzed using both devices, one analyst Precision study sample preparation would label and load five Instant-View test cards while the Precisionwas determined using urine samples(test samples) other analyst labeled and loaded five TesTcups.Analysts alterfortified with the device-specifictarget analytesat 0, 25, 50, 75, nated working with one device or the other. Analyses were 125, 150, and 175% of the respective cutoffs listed in Table I. done essentially as described in the manufacturers' package inBecauseof cutoff and target analyte differences, separatesets serts (4,5). Approximately 0.6 mL of urine was placed into the of test samples were prepared for each device using the folsample reservoir at the bottom of the Instant-View test card lowing steps.A pool of urine was determined to be drug-free by (see optional procedure for small sample volumes). A similar GO-MS analyses. For each device, seven different stocks that procedure was used for TesTcup. Before use, the plastic covcontained all five analytes listed in Table I were prepared (unering of the sample reservoir was removed, and approximately lessthe 0% concentration was used),with random assignment 0.6 mL of urine was added directly to the reservoir. This procedure of adding urine Table I. Primary Analyle and Cutoff Concentrations for ScreeningAssays to the testing reservoir of the TesTcup,is (...truncated)