Verichem Laboratories, Providence, RI, announced the availability of an extensive line of ready-to-use, liquid-stable Clinical Reference Materials intended for the calibration and calibration verification of clinical testing systems. These products support overall quality control and CLIA compliance and are valuable tools in determining a clinical system’s bias to the true or known value. Using unique formulations and set point designs, these reference materials are crucial for the independent determination of test method accuracy, sensitivity, linearity, and reportable range. Verichem’s line of clinical reference materials meet all CLIA, CAP, and CLSI recommendations for verification materials with known values to address the needs of a wide variety of medical laboratory professionals, including those involved in routine laboratory testing, clinical research applications, and in the development and manufacturing of in vitro diagnostic (IVD) products.
Verichem’s Clinical Reference Materials are manufactured employing a proprietary stabilization process using highly purified source components, without azides, glycols, or surfactants, for exceptional open-vial and product shelf-life stabilities, with negligible lot-to-lot variations. The material’s protein balance, pH, and viscosity are kept constant across all concentration levels for optimum linearity, while the liquid stable format eliminates matrix variations, reconstitution errors, special diluents, or any product manipulations.
Verichem’s Clinical Reference Materials are intended to be treated as patient specimens with a wide variety of testing methodologies and have universal compatibility with all wet chemistry testing systems. These products have field proven and documented performance with a number of major analyzers, including those from Abbott Diagnostics, Advanced Instruments, Beckman Coulter, Medica Corporation, Roche Diagnostics, and Siemens Healthineers, among others. Currently, there are over 40 separate clinical chemistry diagnostic analytes found within these products, with other components in active development.
All of Verichem’s Clinical Reference Materials are filled easy-to-use, opaque polyethylene dropper vials, or amber serum vials with rubber-lined closures, and packaged into ergonomically designed test kits. When applicable, Verichem products are shipped with a Certificate of Analysis (COA), providing full traceability and certified accuracy using reference materials available from USP, ACS, and NIST. Extensive technical support services are also offered, including a free web-based data reduction program for instant calibration verification reports which include accuracy, linearity, and peer comparisons to support analyzer performance and system troubleshooting.
Verichem Laboratories serves the clinical laboratory testing and in vitro diagnostic (IVD) manufacturing markets with a comprehensive line of calibration verification products, assay verifiers, calibrators, chemistry standards, linearity and reference materials, and support services including free, instant online data reduction reports for CLIA compliance.
For more information, visit Verichem Laboratories.
Featured image: All of Verichem’s Clinical Reference Materials are filled easy-to-use, opaque polyethylene dropper vials, or amber serum vials with rubber-lined closures. (Courtesy: Verichem Laboratories)