August 2016


LGC Maine Standards is pleased to announce the release of our VALIDATE® Tumor Markers and VALIDATE® Whole Blood Glucose calibration verification / linearity test kits. VALIDATE Tumor Markers evaluates Carcinoembryonic Antigen and Cancer Antigens 15-3, 19-9, and 125 in a human serum-based matrix. VALIDATE Whole Blood Glucose evaluates Glucose in human whole-blood on blood glucose meter systems used in hospital point-of-care settings.

Recently, the US FDA has issued warnings regarding deaths due to interferences with glucose meters used with hospitalised patients and have released a draft guidance that defines new testing and performance requirements for hospital glucose meters and for non-hospital self-monitoring blood glucose devices. The release of VALIDATE Whole Blood Glucose will allow hospitals to better complete their calibration verification / linearity testing – maximizing reportable ranges while
minimising manual dilutions.

Each VALIDATE test kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid, ready-to-use. Simply dispense product from dropper bottle and run in replicates.

The addition of VALIDATE Tumor Markers and VALIDATE Whole Blood Glucose to the LGC Maine Standards portfolio of products demonstrates a continued commitment to manufacture high quality calibration verification / linearity products that meet industry needs.

LGC Maine Standards is located in Cumberland Foreside, Maine, US, and  manufactures VALIDATE calibration verification / linearity test kits for over 100 analytes, including General Chemistries, Urine Chemistries, Enzymes, Lipids, HbA1c, Therapeutic Drugs, Cardiac Markers, Thyroids, Serum Proteins, Vitamin D, Tumor Markers, Anemia, Fertility, Whole Blood Glucose, and D-Dimer.

LGC Maine Standards MSDRx® data reduction software is available at no charge for real-time data analysis or, in the United States, 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.