VALIDATE® Body Fluids will make it easier for laboratories to support LDT validation, documentation of linearity, calibration verification and verification of the AMR for analytes in cerebrospinal, peritoneal ascites, pleural and pericardial body fluids, via our simulated body fluid matrix.
CUMBERLAND FORESIDE, Maine – March 29, 2018 – LGC Maine Standards1 releases the only comprehensive body fluids kit on the market, VALIDATE® Body Fluids, Order Number 205ro, for easier linearity and calibration verification. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification and verification of linear range for Albumin (ALB), Amylase (AMY), Cancer Antigen 19-9 (CA 19-9), Carcinoembryonic Antigen (CEA), Cholesterol (CHOL), Creatinine (CREA), Glucose (GLU), Lactate (LAC), Lactate dehydrogenase (LD), Total protein (TP), Triglycerides (TRIG), and Urea Nitrogen (UN). Each VALIDATE® Body Fluids kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations to establish the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.
Release of VALIDATE® Body Fluids allows clinical laboratories to complete their required Body Fluids linearity and calibration verification, validation of in-house methods or laboratory developed tests (LDT) for analytes in body fluids – 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 Clinically Reportable Range (CRR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.
The addition of VALIDATE® Body Fluids to the 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 130 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Hemostasis, Whole Blood Glucose, and Body Fluids.
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.
Maine Standards Company, LLC
221 US Route 1, Cumberland Foreside, ME 04110
LGC is an international life sciences measurement and testing company 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, including reference materials and proficiency testing, calibration verification / linearity testing, genomics reagents and instrumentation, and expert sample analysis and interpretation. LGC serves customers across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Food, Environment, Government and Academia.
LGC’s headquarters are in London and the company employs over 2,000 people, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025, GMP, GLP, ISO Guide 34, ISO/IEC 17043 and ISO 13485:2003.
With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC was privatized in 1996 and is now owned by funds affiliated with KKR. For more information, please visit www.lgcgroup.com.
1LGC Maine Standards is the brand name for Maine Standards Company, LLC.