Verichem Laboratories, Providence, RI, has introduced a line of liquid stable, protein-based, bilirubin reference materials. The bilirubin standard kit and optional bilirubin standard-level F are specifically designed and intended for calibration verification of total and direct bilirubin assays with any wet-chemistry, clinical testing systems. The company also offers the Tru-Zero bilirubin standard as an optional zero concentration (0.0 mg/dL) level for both analytes.
The ready-to use bilirubin standards are treated as patient specimens, with no preparation or diluents required. All have had their assigned concentration levels verified with the Doumas reference method, and the included certificate of analysis provides verification data using pure crystalline bilirubin reference material. The standard’s unique protein-based formulation, along with a set point design using the CLSI EP06-A linearity protocol, are critical for determination of the testing method’s accuracy, sensitivity, linearity, and reportable range.
All of the standard materials are conveniently packaged in amber serum vials with rubber-lined closures containing 5 mL of standard at each level. The bilirubin standard kit contains five concentration levels, while the extended range level F also contains two vials with a 30 mg/dL concentration level. All of the bilirubin standards incorporate a proprietary stabilization process that negates the need for azides, glycols, or surfactants. The standards feature a refrigerated open-vial product stability claim of 5 days, with a shelf-life claim of 14 months when stored at 2° C to 8° C.
For more information, visit Verichem Laboratories.
