CUMBERLAND FORESIDE, Maine, Dec. 12, 2020 /PRNewswire/ — LGC Maine Standards¹ announces the release of VALIDATE® Anemia to meet the linearity and calibration verification needs of clinical laboratories running the Ortho Vitros® platform. The product (Order No. 308VT), which includes analytes Ferritin, Folate, and Vitamin B12, 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 Ortho Vitros® instrument. VALIDATE® Anemia 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 establish the assays’ reportable range.
When combined with Iron in VALIDATE® GC2 (Order No. 1200VT), Total Iron Binding Capacity in VALIDATE® IBC (Order No. 203VT), and Transferrin in VALIDATE® SP1 (Order No. 601BC), laboratories can challenge the reportable range of Ortho Vitros® anemia assays.
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.
The addition of VALIDATE® Anemia, for the Ortho Vitros®, to 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 140 analytes, including General Chemistries, ACTH, Anemia, Body Fluids, Cardiac, 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.
For VALIDATE® Anemia product details click here or call 1-800-377-9684.
¹LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.
About LGC Clinical Diagnostics
LGC’s Clinical Diagnostics Division develops and manufactures a comprehensive portfolio of catalog and custom-developed diagnostic quality solutions and component materials for the extended life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialization activities across the entire diagnostic pipeline – from concept and early stage research, through expedited product development and onwards into routine clinical use. Laboratorians and diagnostic professionals across disciplines of clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics rely on LGC’s products to support accurate and reliable diagnostic results.
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.
Maine Standards Company, LLC
221 US Route 1, Cumberland Foreside, ME 04110
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SOURCE LGC Maine Standards