Evaluation of the Integrated E-Z Split Key® Cup II for Rapid Detection of Twelve Drug Classes in Urine

• Published in: Journal of analytical toxicology Vol. 35; no. 1; pp. 46 - 53
• Main Authors: Greene, Dina N., Lehman, Christopher M., McMillin, Gwendolyn A.
• Format: Journal Article
• Language: English
• Published: Niles, IL Oxford University Press 2011; Preston Publications
• Subjects: Barbiturates - urine; Biological and medical sciences; Drug addictions; False Positive Reactions; Gas Chromatography-Mass Spectrometry; Humans; Immunoassay; Limit of Detection; Medical sciences; Point-of-Care Systems; Reagent Kits, Diagnostic; Street Drugs - urine; Substance Abuse Detection - methods; Time Factors; Toxicology; Human; Drug; Urine; Biological fluid; Drug addiction; Chemical analysis; Metabolite; Psychotropic; Elimination; Patient; Fraud; Medical screening; Immunological method; Cross reaction; Drug of abuse; Adulteration
• ISSN: 0146-4760; 1945-2403
• DOI: 10.1093/anatox/35.1.46

The availability of point-of-care (POC) medical devices for drug testing has surged. Reduction in turnaround time, and hence, rapid results are attractive, particularly to acute care facilities, rehabilitation facilities and specialized clinics such as pain management clinics. Here we describe our validation results for the Integrated E-Z Split Key Cup II, a low-cost, rapid urine test that utilizes competitive immunoassay technology to detect 12 drugs or drug classes of commonly abused drugs. Positivity is based on the absence of a colored band at a labeled portion of the detection strip; a negative result produces a distinct, colored band. Using reagent-grade standards, the apparent cut-off for each of the drugs was challenged. The stability of the results was monitored over time. Five urine samples known to be negative for all drug categories and 24 patient samples confirmed positive for a total of 95 drugs and/or drug metabolites claimed to be detected by the device were tested. Adulterants and potential cross-reacting compounds were also evaluated. One false-positive result for benzodizepines was observed. One false-negative result for barbiturates was observed, but was resolved. Overall, the cups demonstrated excellent sensitivity, specificity, and diagnostic efficiency for all drugs represented.