Summary: Verichem Laboratories introduced liquid-stable, biosynthetic clinical reference materials designed for calibration verification and quality control of urine chemistry assays across various clinical testing systems.
Takeaways:
- Comprehensive Calibration Verification: Verichem’s clinical reference materials meet CLIA requirements with bio-synthetic matrices mimicking patient specimens, ensuring accuracy, sensitivity, and linearity in urine chemistry assays.
- Validated and Certified Standards: The materials are validated with NIST Standard Reference Materials, include Certificates of Analysis for traceability, and cover 11 critical analytes like Albumin, Creatinine, and Uric Acid.
- User-Friendly and Stable Design: Packaged in ergonomic, dropper vials free from interfering constituents, the materials offer exceptional lot-to-lot consistency and stability for multiple testing applications.
Verichem Laboratories is offering clinical laboratorians an extensive line of liquid stable and ready-to-use biosynthetic clinical reference materials for urine chemistry assays. The materials are expressly designed for the calibration verification of urine chemistry assays on various wet clinical testing systems.
The materials are fashioned to support overall system QC and CLIA compliance within the clinical laboratory and their availability is certain to address the needs of a wide variety of laboratory professionals, including those performing routine diagnostic testing, clinical research applications, and in the development and manufacturing of in-vitro diagnostic (IVD) products.
About the Clinical Reference Materials
All of Verichem’s urine chemistry clinical reference materials incorporate a unique bio-synthetic matrix which allows for urine-like reactivity, as the materials are intended to be treated as actual patient specimens. The innovative matrix formulation and set point design, with equidistant target concentrations, addresses the current CLIA requirements for calibration verification materials used for the determination of a clinical system’s accuracy, sensitivity, linearity, and reportable range.
Plus, each of the concentration levels for the analytes are validated using available Standard Reference Materials from the National Institute of Standards and Technology (NIST), when applicable, and are shipped with a lot-specific Certificate of Analysis indicating accuracy traceability and actual test data. This multi-level offering of clinical reference materials for urine chemistries encompasses 11 separate urine chemistries and includes the analytes Albumin, Calcium, Chloride, Creatinine, Magnesium, Phosphorus, Potassium, Sodium, Total Protein, Urea Nitrogen, and Uric Acid.
Plus, all products display exceptional lot-to-lot consistencies and exceptional stability claims, while being free of surfactants, azide, glycols, and other potentially interfering constituents. All materials are packaged within ergonomically designed kit formats and are filled in easy-to-use, non-reactive, polyethylene dropper vials containing product fill volumes ample enough to cover multiple testing events.
Photo: Verichem Laboratories