04
November 2019

LGC Maine Standards announces VALIDATE® SP1 kit targeted for Roche cobas® and Roche COBAS INTEGRA® analyzers, for easier Serum Protein linearity and calibration verification

LGC Maine Standards has announced the release of VALIDATE® SP1 linearity and calibration verification kit, specifically targeted for Roche cobas® and Roche COBAS INTEGRA® analyzers, Order No. 601ro.

The kit, in a human-serum matrix, evaluates α1-Antitrypsin (ATT), Complement C3 (C3), Complement C4 (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Transferrin (TRFN). 

Each VALIDATE SP1 kit, liquid, ready-to-use, and prepared using the CLSI EP06-A “equal delta” sample preparation, offers five distinct concentrations covering the reportable range. Simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates.

VALIDATE SP1 (601ro), for Roche cobas and Roche COBAS INTEGRA users, complements our existing VALIDATE SP2 (Order No. 602re) & SP3 (Order No. 603ro) products, which target recoveries for ALB, CER, CRP, HPT, PAB, RF, and AAG, ASO, B2M, IGE, respectively.  Together, these Serum Protein VALIDATE offerings provide 17 analytes for easy, fast, and efficient linearity and calibration verification testing – maximizing the reportable range, while minimizing manual dilutions.  Use of these products, while augmenting daily QC, assists with fulfilling various quality control requirements – such as Reportable Range and Analytical Measurement Range (AMR) – for linearity and calibration verification under CLIA ‘88, CAP, COLA, JCAHO, JCI and ISO 15189.

The addition of VALIDATE SP1, for Roche cobas and Roche COBAS INTEGRA analyzers, 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 140 analytes, including General Chemistries, Urine Chemistries, Body Fluid Chemistries, Enzymes, Lipoproteins, 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.