LGC Maine Standards¹ announces a product update for VALIDATE® Diabetes which meets the linearity and calibration verification needs of clinical laboratories running the Roche cobas® platform.
The product (Order No. 204RO), which includes the analytes beta-hydroxybutyrate (BHB)*, C-peptide (C-PEP), Fructosamine (FRUC), Insulin (INS), and now Glucose (GLU), is formulated in a human serum matrix, using the CLSI EP06-A "equal delta" sample preparation method, and provides five distinct concentrations across the claimed range of the Roche cobas® instrument. VALIDATE® Diabetes test kits are liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay's reportable range.
When combined with Micro-Albumin (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 can challenge the reportable range of Roche cobas® Diabetes-related assays.
VALIDATE® Diabetes is FDA listed and offers five Levels of complete reportable range coverage – eliminating the need for manual dilutions! VALIDATE® products allow clinical laboratories to complete their required linearity and calibration verification, maximizing the reportable range while minimizing manual dilutions. Use of this product, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Analytical Measurement Range (AMR) and Reportable Range – for linearity and calibration verification under CLIA '88, CAP, COLA, JCAHO, JCI, and ISO 15189.
With the addition of Glucose to VALIDATE® Diabetes, LGC Maine Standards' expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
LGC Maine Standards is located in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 150 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Bone, Cardiac, 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 at no charge for real-time data analysis, or a laboratory 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. Peer group comparison is also available upon request.
Our operating entities include SeraCare Life Sciences and Maine Standards Company, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials) and The Native Antigen Company, which is a manufacturer and supplier of viral antigens. Our 300+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited facility in Oxford, UK.
Each day, our world-class staff, scientific expertise, operational efficiency and superior quality systems are ready to support the range of advanced technologies that collectively improve patient outcomes - from the widely adopted and established through to cutting-edge NGS and precision diagnostics.