The Defined HHS/DOT Substituted Urine Criteria Validated Through a Controlled Hydration Study

• Published in: Journal of analytical toxicology Vol. 26; no. 7; pp. 419 - 423
• Main Authors: Edgell, Kenneth, Caplan, Yale H., Glass, Leon R., Cook, Janine Denis
• Format: Journal Article
• Language: English
• Published: England Oxford University Press 01-10-2002
• Subjects: Adult; Creatinine - urine; Drinking; Drug Contamination; Female; Humans; Male; Middle Aged; Occupational Health; Predictive Value of Tests; Reference Values; Specific Gravity; Substance Abuse Detection - methods; Substance Abuse Detection - standards; Substance-Related Disorders - diagnosis; United States; United States Dept. of Health and Human Services; Urinalysis - standards; Workplace; United States
• ISSN: 0146-4760; 1945-2403
• DOI: 10.1093/jat/26.7.419

This controlled hydration study was designed to validate the substitution criteria used by the Substance Abuse and Mental Health Services Administration (SAMHSA) to classify a workplace urine specimen as inconsistent with normal human urine. Study participants (n = 56) ingested at least 80 oz (2370 mL) of fluid over a 6-h period, 40 oz during the first 3 h (DOT hydration protocol) and 40 oz during the second 3-h period. Urine specimens (n = 498) were collected upon awakening, just prior to hydration, at the end of each hour of the 6-h test period, and upon awakening the next day. No urine specimen satisfied the paired substitution criteria of urine creatinine ≤ 5.0 mg/dL and specific gravity ≤ 1.001 or ≥ 1.020. Seventy-three percent of the participants produced at least one specimen meeting the criteria for dilute urine: urine creatinine < 20.0 mg/dL and specific gravity < 1.003. Fifty-five percent of the participants produced at least one dilute urine specimen during the first 3 h of hydration. In conclusion, this controlled hydration study supports the criteria set by SAMHSA for classifying a specimen as substituted (inconsistent with normal human urine).