In this database, 13,467 urine specimens had both creatinine and specific gravity measurements. We reviewed the results of 803,130 random urine specimens measured for creatinine and/or specific gravity in a hospital-based laboratory. These criteria have been criticized based on the contention that an insufficient number of specimens had been tested from the same urine sample for both creatinine and specific gravity measurements.
The United States Department of Transportation Regulations (49 Code of Federal Regulations Part 40) defines a urine specimen as substituted if it has a creatinine concentration of ≤5 mg/dL and a specific gravity of ≤1.001 or ≥1.020. The purpose of this study was to determine whether people could naturally produce urine sufficiently dilute to meet the federal criteria for a "substituted" specimen.
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