PROVIDENCE, RI — Verichem Laboratories announces 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 unique 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. As Verichem’s line of clinical reference materials meet all CLIA, CAP, and CLSI recommendations for verification materials with known values, their availability is certain 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 represent the cutting edge in calibration testing verification materials. All materials are manufactured employing a proprietary stabilization process using highly purified source components, without azides, glycols, or surfactants, resulting in 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, common with other lyophilized and serum-based products. 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 in these products, with other components in active development.
All 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.