REFERENCE MATERIALS FOR CALIBRATION VERIFICATION TESTING OF CHOLESTEROL ASSAYS NOW AVAILABLE FROM VERICHEM

Verichem Laboratories is pleased to announce that it now offers medical laboratory professionals involved in patient testing, research and development, and diagnostic product manufacturing applications an extensive array of ready-to-use, liquid stable and ready-to-use clinical reference materials for Total Cholesterol, High Density Lipoprotein (HDL), and Low Density Lipoprotein (LDL) testing. Intended for calibration and calibration verification procedures, the Matrix Plus™ Total Cholesterol Reference Kit; the Matrix Plus™ Total Cholesterol Reference – Level F; and the HDL Cholesterol Verifier Kit supports overall laboratory QA and QC efforts. The advanced product design provides materials that are intended to be treated as human specimens and feature universal compatibility with wide variety of automated chemistry clinical systems.

All of Verichem’s clinical reference materials for Total Cholesterol, HDL, and LDL are protein-based and incorporate a proprietary stabilization process, free of azides, glycols, or surfactants. The unique serum-like formulation also contains a critical blend of highly purified human source material and bovine biologicals in saline. The use of such purified source components eliminates the matrix variations, quite common with many other serum-based products, and results in exceptional lot-to-lot product reproducibility and product performance characteristics. In addition, the material’s pH, matrix composition and fresh, human source materials are kept constant for optimum linearity, even with the most sensitive methods. This unique feature, along with a set point designs following CLIA and CLSI protocols, are critical for the determination of a clinical system’s accuracy, sensitivity, linearity, and reportable range and demonstrates the cutting edge in both Total Cholesterol and Lipoprotein reference materials.

The Matrix Plus™ Total Cholesterol Reference Kit, along with the optional Level F, comprise a multi-level six (6) concentration set of materials, with Total Cholesterol values ranging from 40 to 750 mg/dL. Each active component is verified using available Standard Reference Materials from the National Institute of Standards and Technology (NIST) and fully documented with a Certificate of Analysis. The kit offers exceptional optical clarity and is conveniently packaged for multi-use containing fifteen milliliters (15.0 mL) of material filled into easy-to-use, opaque polyethylene dropper vials and offers an outstanding shelf-life stability claim of twenty-one (21) months from the date of manufacture when stored at 2° to 8°C.   

Verichem’s HDL Cholesterol Verifier Kit also comprises a six (6) level concentration set of HDL and LDL Cholesterol determined via direct measurement using certified reference method calibration materials.  This kit also includes a Value Assignment Sheet with target values assigned using various clinical methods. The product is ergonomically packaged with five milliliters (5.0 mL) of material at each concentration level, which is ample to cover multiple verification testing events and other uses. All materials are filled within easy-to-use, translucent polyethylene dropper vials and feature an exceptional shelf-life stability claim of fourteen (14) months from the date of manufacture, when stored at temperatures of -15° to -25°C.  Plus, this unique product can be frozen and thawed for up to ten (10) cycles, without affecting concentration accuracy or test performance. 

VERICHEM LABORATORIES serves the clinical laboratory testing and in-vitro diagnostic (IVD) manufacturing markets with a comprehensive line of calibration verification products, chemistry standards, reference materials, and support services  ̶  including free, instant online data reduction reports for CLIA compliance. For additional information, contact Verichem Laboratories Inc. at 90 Narragansett Avenue, Providence, RI 02907 USA. Phone: 800-552-5859; FAX: 401-467-1540; Email: customerservice@verichemlabs.com. Please visit our website at www.verichemlabs.com