VERICHEM LABORATORIES EXPANDS LINE OF BIO-SYNTHETIC CLINICAL REFERENCE MATERIALS FOR URINE CHEMISTRIES

June 21, 2021

VERICHEM now offers 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 or calibration verification, of urine chemistry assays on a wide variety of wet clinical testing systems, including those from Abbott Diagnostics, Beckman Coulter, Roche Diagnostics, Siemens Healthineers, and Thermo-Fisher, among many others. 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.

All ofVerichem’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 eleven (11) separate urine chemistries and contains a total of fifty-five (55) individual concentration set points, 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.   

                        VERICHEM LABORATORIES serves the clinical laboratory testing and in-vitro diagnostic (IVD) manufacturing markets with a comprehensive line of calibration verification products, chemistry standards, reference materials, and support services ̶ including free, instant online data reduction reports for CLIA compliance. For additional information, contact Verichem Laboratories Inc. at 90 Narragansett Avenue, Providence, RI 02907 USA. Phone: 800-552-5859; FAX: 401-467-1540; Email: customerservice@verichemlabs.com. Please visit our website at www.verichemlabs.com.