The pH Reagent Assay is a universal reagent system intended for use with the Olympus, Hitachi, Cobas, Beckman and other automated systems for the analysis of pH in urine. This reagent is designed to detect urinary pH over a wide range from 2.0 – 12.0 depending upon calibrators used. Urine outside of the range of 4.5 – 9.0 should be suspect. Regulatory agencies have determined that urine samples submitted for drugs of abuse testing to be adulterated if outside the range of 3.0 and 11.0. The analysis is based on an indicator principle that gives a change in absorbance throughout the urinary pH range. A sample of urine is mixed with the reagent and, depending on the hydrogen ion concentration of the urine the indicator will exhibit a change in color. This color change results in an absorbance that is monitored by a detector at 600 nanometers. All abnormal results should be rechecked by a reference method. This test is for In Vitro Diagnostic use as well as for Forensic Toxicology Use.