Verichem Laboratories has announced the availability of ready-to-use, multi-level, clinical reference materials intended for use with toxicology assays on a wide array of diagnostic testing systems. The component materials and available concentration ranges include Acetaminophen: 6.0 to 300.0 mg/L; Lithium: 0.20 to 4.60 mmol/L and/or 0.50 to 5.50 mmol/L; and Salicylate: 2.0 to 100.0 mg/dL. Expressly designed for testing as patient specimens for the calibration verification of the intended components, all materials feature universal instrument compatibility, making them suitable for use on a wide array of wet chemistry analyzers. These unique formulations eliminate time-consuming reconstitution procedures with a liquid, non-interfering matrix.
Verichem’s clinical reference materials for toxicology assays incorporate a unique bio-synthetic design encompassing the serum-like reactivity of a protein-based product coupled with the gravimetric accuracy of an absolute standard. This cutting edge matrix, free of surfactants, glycols, azides, and other interfering substances, also allows for exceptional product stability with undetectable lot-to-lot variation. CLIA compliant concentration designs, at or near decision cut off concentrations, are vital for the determination of test method accuracy, sensitivity, linearity, and reportable range, with all concentrations directly verified using Standard Reference Materials available from either NIST or USP.
Certain to address the needs of a wide variety of medical laboratory professionals, Verichem’s clinical reference materials for toxicology assays are ergonomically packaged and contain ample volumes of materials at each of the six (6) available concentration levels to accommodate multiple calibration events or any potential troubleshooting incidents. The standards are filled within convenient polyethylene, multi-use dropper vials and include a lot specific certificate of analysis indicating accuracy traceability and actual lot testing data.
Verichem Laboratories serves the clinical laboratory testing and in-vitro diagnostic (IVD) manufacturing markets with a comprehensive line of clinical reference materials, calibration verification products, chemistry standards, linearity confirmation materials, and support services ̶including free, instant online data reduction reports for full CLIA compliance, according to the company.