LGC Maine Standards announces VALIDATE® ACTH kit for Roche cobas® with easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification

CUMBERLAND FORESIDE, Maine, June 23, 2020 /PRNewswire/ -- LGC Maine Standards¹ announces the release of VALIDATE^® ACTH Linearity and Calibration Verification Test Kits for easy, fast, and reliable documentation of linearity, calibration verification, and Analytical Measurement Range (AMR) verification of Adrenocorticotropic Hormone (ACTH). The product (Order No. 302MM) is formulated in a human plasma matrix, using the CLSI EP06-A "equal delta" sample preparation method, and provides five distinct concentrations across the claimed range of the Elecsys-ACTH Method on the Roche cobas^®. VALIDATE^® ACTH 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 assay's reportable range.

VALIDATE^® ACTH strengthens LGC Maine Standards' product range for endocrine testing, which now includes 17 analytes:

• THYROID: Free T3, Free T4, Total T3, Total T4, TSH and Cortisol
• PSA: free PSA, total PSA
• FERTILITY 1: FSH, hCG, Luteinizing Hormone, Prolactin
• FERTILITY 2: AFP; DHEA-S, Estradiol, Progesterone

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^® ACTH 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, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis and Whole Blood Glucose. 

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^® ACTH product details click here or call 1-800-377-9684.

¹LGC Maine Standards is the brand name for Maine Standards Company, LLC.

About LGC

LGC Group is a UK-headquartered life sciences measurement and testing business with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public. LGC's Clinical Diagnostic Business Unit (CDBU) is comprised of two operating entities - SeraCare Life Sciences and Maine Standards Company – and are in vitro diagnostic (IVD) manufacturers of clinical diagnostic quality solutions to the extended life science industry.

Our 200+ employees operate FDA-registered and ISO 13485-accredited facilities in Maine, Massachusetts and Maryland and support diagnostic professionals in laboratories across the globe. We partner with IVD developers, pharmaceutical, CRO and academic institutions to share our expertise and resources in clinical chemistry, immunochemistry, serology, molecular diagnostics and clinical genomics.

We are committed to improving patient healthcare by offering products and services that support accurate and reliable diagnostic results.

SOURCE LGC Maine Standards