LGC Maine Standards announces the release of VALIDATE® Immunosuppressants (ISx) to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT/ALINITY or Siemens Dimension platform(s).

The product, which includes analytes Cyclosporine (CSA)*, Tacrolimus (TAC), and Sirolimus (SIRO), is formulated in human whole blood, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed and extended range of the Abbott ARCHITECT/ALINITY, or Siemens Dimension instruments. VALIDATE ISx 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.

VALIDATE products allow clinical laboratories to complete their required linearity, calibration verification, and Analytical Measurement Range (AMR) 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 ISx 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 Standards1 is in Cumberland Foreside, Maine and manufactures VALIDATE linearity and calibration verification kits for over 165 analytes, including General Chemisty, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, 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.

VALIDATE ISx Product Information

About LGC

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers' products and workflows and are valued for their performance, quality and range.

LGC's tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products.

LGC's 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community.

LGC's core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master's degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.

About LGC Clinical Diagnostics

LGC Clinical Diagnostics business unit 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 LGC Clinical Diagnostics, Inc. (formerly known as SeraCare Life Sciences and Maine Standards, LLC), and Technopath Clinical Diagnostics which are in vitrodiagnostics (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 400+ 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.

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