Maine Standards announces VALIDATE® SARS-CoV-2 IgG for Abbott ARCHITECT/ALINITY, Beckman Coulter Unicel® DxI/Access, Ortho VITROS, and Siemens ADVIA Centaur® immunoassays for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification.
CUMBERLAND FORESIDE, Maine – April 25, 2022
Maine Standards¹ announces the release of VALIDATE® SARS-CoV-2 IgG (Order No. 510mm) to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT/ALINITY, Beckman Coulter Unicel® DxI/Access, Ortho Vitros, or Siemens ADVIA Centaur platforms. The product is formulated in a human plasma matrix. VALIDATE® SARS-CoV-2 IgG test kits are FDA-listed, CE-marked, liquid and ready-to-use; simply dispense the solution from each dropper bottle directly into five or six sample cups and run in replicates to verify the assay’s reportable range.
The product is manufactured using The Native Antigen Company’s Human IgG1 Anti-SARS-CoV-2 Spike (S1) RBD Antibody (DH6), which is a recombinant humanized monoclonal antibody against SARS-CoV-2 receptor-binding domain (RBD) protein, but not against SARS-CoV-1 or MERS-CoV. The antibody was characterized and its concentration quantitated by the UK National Measurement Laboratory at LGC.
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 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® SARS-CoV-2 IgG to Maine Standards’ expanding portfolio of products demonstrates a continued commitment to manufacture high-quality linearity and calibration verification products that meet industry needs.
Maine Standards is in Cumberland Foreside, Maine and manufactures VALIDATE® linearity and calibration verification kits for over 165 analytes, including General Chemistry, ACTH, Anemia, Body Fluids, Bone, Cardiac, Diabetes, Fertility, Hemostasis, Immunosuppressants, Osmolality, POC, SARS-CoV-2, Sepsis, Serum Proteins, Therapeutic Drug Monitoring, Thyroid, Tumor Markers, and Urine Chemistry.
Maine Standards’ MSDRx® data reduction software is available at no charge for real-time data analysis, or a laboratory can send their data to 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® SARS-CoV-2 IgG product details, click here, or call 800-377-9684.
¹Maine Standards and The Native Antigen Company are product brands of LGC Clinical Diagnostics.
About LGC Clinical Diagnostics
LGC Clinical Diagnostics 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 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 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.