LGC Maine Standards, Cumberland Foreside, Maine, has released the Validate hsTnT linearity and calibration verification kit for Roche Cobas analyzers. The kit is the only linearity and calibration verification material specifically targeting Roche’s troponin T Gen 5 Stat (TnTG5) assay range in a human serum matrix. Each Validate hsTnT kit is prepared using the CLSI EP06-A ‘equal delta’ sample preparation method, and offers five distinct concentrations covering the reportable range of the hsTNT assay. Users dispense the ready-to-use solution from each dropper bottle directly into five sample cups and run in replicates.
The release of Validate hsTnT for Roche Cobas users enables clinical laboratories to complete their required high-sensitivity troponin linearity and calibration verification and maximize the reportable range, while minimizing manual dilutions. Use of the product augments daily quality control and assists with fulfilling various quality control requirements, such as reportable range and analytical measurement range, for linearity and calibration verification under the requirements of the Clinical Laboratory Improvement Amendments of 1988 (CLIA); accreditation requirements of the College of American Pathologists, COLA, the Joint Commission, the Joint Commission International; and the laboratory quality systems standard compiled by the International Organization for Standardization, ISO 15189.
The addition of Validate hsTnT, for Roche Cobas analyzers to the LGC Maine Standards expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs. The company manufactures Validate linearity and calibration verification kits for 137 analytes, including anemia, body fluid chemistries, cardiac markers, enzymes, fertility, general chemistries, HbA1c, hemostasis, lipids, serum proteins, therapeutic drugs, thyroids, tumor markers, urine chemistries, vitamin D, and whole blood glucose.
LGC Maine Standards MSDRx data reduction software is available at no charge for real-time data analysis. Laboratories can also send their data to LGC Maine Standards for data analysis by a technical specialist and expect returned reports within 5 business days. Peer group comparison is also available upon request.
To learn more, visit LGC Maine Standards.