Ann Lab Med 2017; 37(6): 522-525  
Evaluation of the Triage TOX Drug Screen Assay for Detection of 11 Drugs of Abuse and Therapeutic Drugs
Hae In Bang, M.D.1,*, Mi-Ae Jang, M.D.2,*, and Yong-Wha Lee, M.D.2
Department of Laboratory Medicine1, Soonchunhyang University Seoul Hospital, Soonchunhyang University College of Medicine, Seoul; Department of Laboratory Medicine and Genetics2, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, Bucheon, Korea
Correspondence to: Yong-Wha Lee
Department of Laboratory Medicine and Genetics, Soonchunhyang University Bucheon Hospital, Soonchunhyang University College of Medicine, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
Tel: +82-32-621-5943 Fax: +82-32-621-5944 E-mail: lywmd@schmc.ac.kr
*These authors contributed equally to this manuscript.
Received: October 31, 2016; Revised: March 2, 2017; Accepted: June 25, 2017; Published online: November 1, 2017.
© The Korean Society for Laboratory Medicine. All rights reserved.

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Abstract
The demand for rapid and broad clinical toxicology screens is on the rise. Recently, a new rapid toxicology screening test, the Triage TOX Drug Screen (Alere Inc., USA), which can simultaneously detect 11 drugs of abuse and therapeutic drugs with an instrument-read cartridge, was developed. In the present study, we evaluated the efficacy of this new on-site immunoassay using 105 urine specimens; the results were compared with those obtained by using ultra-performance liquid chromatography with tandem mass spectrometry (UPLC-TMS). Precision was evaluated according to the CLSI EP12-A2 for analyte concentrations near the cutoff, including C50 and±30% of C50, for each drug using standard materials. The C50 specimens yielded 35-65% positive results and the±30% concentration range of all evaluated drugs encompassed the C5-C95 interval. The overall percent agreement of the Triage TOX Drug Screen was 92.4-100% compared with UPLC-TMS; however, the Triage TOX Drug Screen results showed some discordant cases including acetaminophen, amphetamine, benzodiazepine, opiates, and tricyclic antidepressants. The overall performance of the Triage TOX Drug Screen assay was comparable to that of UPLC-TMS for screening of drug intoxication in hospitals. This assay could constitute a useful screening method for drugs of abuse and therapeutic drugs in urine.
Keywords: Agreement, Immunoassay, Drugs of abuse, Tandem mass spectrometry, Therapeutic drugs, Precision


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