Expressly designed for system calibration verification testing procedures, the materials feature full system compatibility on a wide variety of wet clinical testing platforms, including those from Abbott, Beckman Coulter, Roche, and Siemens, among many others, according to the company. The materials are fashioned to assist laboratorians in meeting CLIA compliance, while supporting overall system quality control. This multi-level offering of clinical reference materials for urine chemistries includes the analytes Albumin, Calcium, Chloride, Creatinine, Magnesium, Microprotein, Phosphorus, Potassium, Sodium, Total Protein, Urea Nitrogen and Uric Acid.
All of Verichem’s urine chemistry clinical reference materials incorporate a bio-synthetic matrix which allows for complete urine-like reactivity, as the materials are intended to be treated as actual patient specimens. Their matrix formulation and set point designs, with equidistant target concentrations, meets the current CLIA requirements for calibration verification materials used for the determination of a clinical system’s accuracy, sensitivity, linearity, and reportable range. Plus, each of the concentration levels for the analytes are validated using available Standard Reference Materials from the National Institute of Standards and Technology (NIST), when applicable, and are shipped with a lot-specific certificate of analysis indicating traceability and actual test data. As such, their availability is aimed to address the needs of a wide variety of laboratory professionals, including those engaged with routine clinical testing, those performing medical research applications, and in the development, manufacturing, and support of in-vitro diagnostic (IVD) products.
Plus, all of the products feature minimum shelf-life stability claims of 17 months, or more, along with exceptional lot-to-lot consistencies and product performance characteristics, while being free of surfactants, azides, glycols, and other potentially interfering constituents. All materials are packaged within ergonomically designed kit formats and are filled in easy-to-use, non-reactive, polyethylene dropper vials containing product fill volumes ample enough to cover multiple testing and trouble-shooting events.
Photo: Verichem Laboratories