Summary: Verichem Laboratories has introduced the Enzyme ER Calibration Verifier Kit, a comprehensive and versatile tool for enzyme assay calibration verification in clinical testing, research, and IVD product development.

Takeaways:

  1. The materials are designed for the calibration verification of enzyme assays on “wet” chemistry testing system and contain nine separate clinical enzyme components covering 54 individual activity levels.
  2. The enzyme components included within the materials include Amylase, ALT, ALP, AST, Cholinesterase, CK, GGT, LD, and Lipase.
  3. These reference materials are intended to be treated as patient specimens and feature universal instrument compatibility, making them available for use on a wide assortment of clinical instrument systems

Verichem Laboratories now offers a multi-level, multi-analyte, and ready-to-use Enzyme ER Calibration Verifier Kit that is for use in routine clinical testing, research applications, and in the development and manufacturing of in-vitro diagnostic (IVD) products. 

The Enzyme ER Calibration Verifier Kit

The materials are expressly designed for the calibration verification of enzyme assays on “wet” chemistry testing system and contain nine separate clinical enzyme components covering a total of 54 individual activity levels. The enzyme components included within the materials include Amylase, ALT, ALP, AST, Cholinesterase, CK, GGT, LD, and Lipase.

Verichem’s Enzyme ER Verifiers represent the cutting-edge in enzyme calibration verification materials, as its proprietary formulation is specifically designed to include at least one set point for each enzyme within the normal range. 

Reference Materials for Diverse Applications

These reference materials are intended to be treated as patient specimens and feature universal instrument compatibility, making them available for use on a wide assortment of clinical instrument systems, as well as offering an outstanding shelf-life and open-vial stability claim of a full 18 months. Plus, the use of purified source components used in the manufacturing process, along with the liquid stable format, eliminates matrix variations and reconstitution errors commonly experienced with lyophilized or serum-based products.

In addition, the material’s protein balance, pH, and ion content are constant across concentration levels for optimum linearity. The linear relation for the materials is included in the product insert so that the kit can be used for reportable range verification of any automated “wet” chemistry method. 

Further reading: Verichem Upgrades CLIA-Compliant Data Reduction and Test Reporting Software

Plus, for added convenience, a separate value assignment sheet is included with targets for popular Abbott, Beckman Coulter, and Roche Diagnostics clinical chemistry systems, Verichem says. Verichem’s Enzyme ER Verifiers are packaged for multi-use and contain an ample five milliliters (5.0 mL) of material for each of the six levels contained within each kit, with each level filled into easy-to-use polyethylene dropper vials.