Tsai S-C.J., Towt J., Kravec C., Oades B., Rashid F., Talbot L., Twarowska. B., Salamone S.J.

Roche Diagnostic Systems, Inc., 1080 US Highway 202, Somerville, NJ 08876, USA

With the growing interest in the on-site detection of drugs of abuse in urine, there has been a need for a testing device that is easy to use and reliable. The aim of this abstract is to present the performance of ONTRAK TESTCUP^®-5, a self-contained specimen collection and drug testing device for the simultaneous screening of five drugs at the following cutoff levels: amphetamines (1000 ng/mL), cocaine metabolite (300 ng/mL), cannabinoids/THC (50 ng/mL), morphine (300 ng/mL), and phencyclidine (25 ng/mL).
Methods. The TESTCUP assays are based on the principle of competitve immunoassay whereby drug in the urine competes with a membrane-impregnated drug conjugate for the specific antibody on colored microparticles. The appearance of a colored bar at the detection window for each drug indicates a negative result. No band is observed if the drug is present in the urine sample at or above the cutoff for the corresponding assay. The precision of TESTCUP-5 was determined using controls containing various concentrations of the drug analytes detected by this system. Clinical performance of TESTCUP-5 was evaluated and compared to Abuscreen ONTRAK^® using specimens that were prescreened as either positive or negative at a clinical testing laboratory by Abuscreen ONLINE^® immunoassay. The clinical positive samples were confirmed with GC/MS. The specificity was assessed using structurally similar compounds for each of the five assays.
Results. The total precision of TESTCUP-5 shows that the TESTCUP can distinguish negative and positive samples with a high degree of confidence when the drug concentrations are at or less than 50% and at or greater than 150% of the cutoff. Of the pre-screened clinical specimens, there was greater than 95% agreement between TESTCUP and ONTRAK. The sensitivity of the TESTCUP for GC/MS confirmed positive samples is greater than 95% for all 5 assays. Some of the positive specimens were positive for multiple drugs as simultaneously detected by TESTCUP. The cross-reactivities of structurally related compounds for each of the 5 assays were similar to those of the ONTRAK and ONLINE assays.
Conclusion: The TESTCUP assay system is an all-in-one, easy-to-use tool for the on-site testing of multiple drugs. It is a testing device that also serves as a container for specimen collection, storage and shipment to a secondary laboratory for confirmation testing. In under five minutes, TESTCUP-5 can provide results that are comparable to other proven instrument or non-instrument based immunoassays available on the market.