Summary: Verichem Laboratories has launched a comprehensive range of liquid-stable clinical reference materials for calibration verification testing of cholesterol assays, designed to support laboratory QA and QC efforts for total cholesterol, HDL, and LDL testing.
Takeaways:
- Verichem’s reference materials are protein-based, stable, and free of common additives, ensuring compatibility with various automated clinical systems and reducing matrix variations.
- The Matrix Plus Total Cholesterol Reference Kit and HDL Cholesterol Verifier Kit offer multi-level concentration sets for accurate calibration, following CLIA and CLSI protocols.
- These materials provide long shelf-life stability, with the HDL kit allowing up to 10 freeze-thaw cycles without compromising accuracy or performance.
Verichem Laboratories is offering an extensive array of liquid stable and ready-to-use clinical reference materials for total cholesterol, high-density lipoprotein (HDL), and low-density lipoprotein (LDL) testing.
Calibration Verification Testing
Intended for calibration and calibration verification procedures, Verichem’s Matrix Plus Total Cholesterol Reference Kit; the Matrix Plus Total Cholesterol Reference – Level F; and the HDL Cholesterol Verifier Kit support 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 a wide variety of automated chemistry clinical systems.
Verichem Reference Materials
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 forefront in both total cholesterol and lipoprotein reference materials.
About the Calibration Kits
The Matrix Plus Total Cholesterol Reference Kit, along with the optional Level F, comprise a multi-level six concentration set of materials, with Total Cholesterol values ranging from 40mg/dL to 750mg/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 materials offer exceptional optical clarity and are conveniently packaged for multi-use containing 15.0mL, 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 also comprises a six-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 5.0mL 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 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 10 cycles, without affecting concentration accuracy or test performance.
