Verichem Laboratories offers medical laboratory professionals involved in patient testing, research and development, and diagnostic product manufacturing an extensive array of liquid stable and ready-to-use multi-level reference materials for total cholesterol, high density lipoprotein (HDL), and low density lipoprotein (LDL) testing. Intended for calibration verification, the Matrix Plus Total Cholesterol Reference Kit; the Matrix Plus Total Cholesterol Reference – Level F; and the HDL Cholesterol Verifier Kit are designed to address the needs and regulatory requirements of laboratory professionals. The advanced product design provides materials that are intended to be treated as human specimens and feature universal compatibility with wide variety of wet chemistry clinical analyzers, according to the company.
All of Verichem’s protein-based, clinical reference materials for total cholesterol, HDL, and LDL incorporate a proprietary stabilization process, free of azides, glycols, or surfactants. The serum-like formulation also contains a critical blend of highly purified human source material and bovine biologicals in saline, according to the company. 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 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 six level set of materials, with cholesterol concentrations 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 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 21 months from the date of manufacture when stored at 2° to 8°C.
Verichem’s HDL Cholesterol Verifier Kit includes six separate concentration levels 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 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 a shelf-life stability claim of 14 months from the date of manufacture, when stored at temperatures of -15° to -25°C. Plus, this product can be frozen and thawed for up to ten 10 cycles, without affecting concentration accuracy or test performance, according to the company.
Featured Image: Verichem Laboratories offers medical laboratory professionals involved in patient testing, research and development, and diagnostic product manufacturing an extensive array of liquid stable and ready-to-use multi-level reference materials for total cholesterol, high density lipoprotein (HDL), and low density lipoprotein (LDL) testing. Photo: Verichem Laboratories