Verichem Laboratories is committed to develop only the most accurate, protein-based, liquid clinical chemistry reference materials for in vitro diagnostic use. We are dedicated to clinical chemists worldwide whose primary goal is to determine the accuracy of their diagnostic test system.
The advanced technology of clinical analyzers has increased the testing capacity of today's medical laboratory, thereby enhancing the cost-efficiency of operations. Verichem Laboratories, Inc. stands in the forefront of these developments in clinical analysis, focusing on constant improvement of quality control products to meet increasingly stringent performance testing requirements in laboratory instrumentation.
Our ultimate goal is to provide clinical chemists with a protein-based, practical alternative possessing the known values of NIST traceable standards with a cost effective, ready-to-use format. These premium reference materials are supplied with known targets and certified for each lot. For calibration verification, Verichem gravimetric standards are used to determine a clinical system's bias to the true value. High-level protein matrices, simulating patient specimens, make Verichem products ideal for protein sensitive assays that are common in reagent development.
Verichem Laboratories depends upon its extensive field database and reference method traceability for value assignments of its secondary standards and verifiers, such as lipoprotein and bilirubin preparations. This approach minimizes the inaccuracy and variability intrinsic to consensus value assignment, and supports our goal to provide highly accurate standard materials for all clinical laboratories.
Some diagnostic manufacturers use Verichem Laboratories' reference materials for standardization of clinical assays among several instrument models and reagent systems. These Verichem standardized systems operate with minimal instrument variation, while providing the highest accuracy possible.
The entire product line at Verichem Laboratories was designed to deliver accurate, liquid reference standards for convenient calibration or calibration verification. Verichem Laboratories has developed a variety of multi-component standard solutions, with human and bovine protein matrices, formulated to obtain optimum performance with the latest automated methods. During product development, Verichem Laboratories pays strict attention to packaging details including multi-dose dispensing containers for convenient use and product protection.
All Verichem Laboratories lots are performance tested using popular clinical methods.
Our Field Experience
Regarded as the pioneers in liquid protein-based primary standards, Verichem Laboratories' staff can answer any questions you may have about its standard materials and their performance with your system.
Verichem Laboratories' products have been specifically designed by certified medical technologists to meet rigorous requirements of customers in this field. The background of our staff assists us in responding to the need of our clients. Our production team has a unique advantage provided by practical working experience within the medical laboratory that adds proficiency to our technical service. Verichem's technical staff has over 80 years of experience in production and quality control of in vitro diagnostic products.
Quality Control
All Verichem standards are verified against independent clinical standards prepared with available reference materials from the National Institute of Standards and Technology (NIST), United States Pharmacopeia (USP) and/or American Chemical Society (ACS) primary standards. Each lot-specific Certificate of Analysis, supplied in every kit, validates concentration and linearity performance using clinical methods and NIST materials as references, when available.
Verichem Laboratories has accomplished unprecedented technical achievements and continues to advance in linking definitive method value assignment with practicality. Clinical scientists worldwide have recognized the importance of Verichem Laboratories' premium quality control materials in their routine monitoring of clinical chemistry systems.
Verichem Laboratories' standard solutions are noted for the highest quality achieved by the specific processes and the integrity of the components used in manufacture. Submicron filtered deionized water used in Verichem products is monitored for important quality specifications and to assure low microbial content throughout the manufacturing process. All heat stable standard components are dried to constant weight at temperatures appropriate to each material. When constant weight is attained, the compound is stored in an air-tight industrial desiccator protected against atmospheric exposure.
Verichem Laboratories uses modern filtration and production filling techniques for each lot, including peristaltic pumping to reduce the risk of cross contamination. Fill volumes are checked throughout the filling process for accuracy and precision in strict accordance with FDA/cGMP regulations.