May 2018

LGC announces VALIDATE® Fibrinogen for easier linearity and calibration verification on IL ACL TOP® 500, Siemens Sysmex® CS-2500 System, and Stago STA-R® Evolution hemostasis test systems

LGC Maine Standards announces VALIDATE Fibrinogen for easier linearity and calibration verification on IL ACL TOP 500 (Order No. 904il), Siemens Sysmex CS-2500 (Order No. 904se), and Stago STA-R Evolution (Order No. 904st) hemostasis test systems.  The kits, in a human, plasma matrix, evaluate Five Levels of recovery across the Fibrinogen (FIB) analytical measurement range (AMR).  Each VALIDATE Fibrinogen kit, liquid and ready-to-use, prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.
The release of VALIDATE Fibrinogen allows clinical laboratories with IL ACL TOP 500, Siemens Sysmex CS-2500, Stago STA-R Evolution or other commonly used hemostasis systems to complete their required Fibrinogen linearity and calibration verification and maximize 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 Fibrinogen 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.