In combination with microalbumin (µALB) in VALIDATE® UC5 (705RO), glycohemoglobin A1c (HbA1c) in VALIDATE® HbA1c (605) and high-density lipoprotein (HDL) and low-density lipoprotein (LDL) in VALIDATE® LP (501RO)) Laboratories question the reportable area of Roche cobas® diabetes-related assays.
VALIDATE® Diabetes is FDA Listed and offers five levels of full reportable area coverage – with no manual dilutions! With VALIDATE® products, clinical laboratories can perform the required linearity and calibration checks to maximize the reportable range and minimize manual dilutions. Using this product increases day-to-day quality control and helps meet various quality control requirements – such as: B. the analytical measuring range (AMR) and the reportable range – for checking the linearity and calibration according to CLIA ’88, CAP, COLA, JCAHO, JCI and ISO 15189.
With the addition of glucose to VALIDATE® Diabetes, the growing product portfolio of LGC Maine Standards shows an ongoing commitment to producing high quality linearity verification and calibration products that meet industry requirements.
LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE® kits for checking linearity and calibration for over 150 analytes, including general chemistries, ACTH, anemia, body fluids, bones, heart, diabetes, fertility, hemostasis, osmolality, POC, sepsis, serum proteins, therapeutic drug monitoring, thyroid , Tumor markers and urine chemistry.
LGC Maine Standards MSDRx® data reduction software is available free of charge for real-time data analysis, or a lab can send their data to LGC Maine Standards, where a technical specialist will complete the data analysis and return a report within five business days. A peer group comparison is also possible on request.
For details on VALIDATE® diabetes products, click here or call 1-800-377-9684.
¹LGC Maine Standards is the brand name for Maine Standards Company, LLC and a company of the LGC Clinical Diagnostics Division.
* Developed and manufactured with Stanbios BHB reagent on the Roche cobas®.
About LGC Clinical Diagnostics
LGC’s clinical diagnostics division designs and manufactures a comprehensive portfolio of catalog and custom quality diagnostic solutions and component materials for the extended life science industry. We work with IVD assay developers as well as pharmaceutical, CRO and academic institutions on commercialization activities across the diagnostic pipeline – from concept and early stage research to accelerated product development to routine clinical use. Laboratory technicians and diagnosticians in the fields of clinical chemistry, immunochemistry, serology, molecular diagnostics, and clinical genomics rely on LGC products to provide accurate and reliable diagnostic results.
Our operating units include SeraCare Life Sciences and Maine Standards Company, manufacturer of in vitro diagnostic (IVD) devices for quality measurement instruments (calibrators, controls, linearity, EQA / PT, biological materials) and The Native Antigen Company, manufacturer and manufacturer supplier of viral antigens. Our more than 300 employees operate FDA registered and ISO 13485 accredited facilities in Maine, Massachusetts and Maryland, USAand an ISO 9001 accredited facility in Oxford, UK.
Every day, our world-class people, scientific expertise, operational efficiencies, and top quality systems are ready to support the range of advanced technologies that work together to improve patient outcomes – from widespread and established to cutting-edge NGS and precision diagnostics.
SOURCE LGC Maine Standards