LGC Maine Standards¹ has released of VALIDATE UC1, VALIDATE UC4, and VALIDATE UC5 to meet the linearity and calibration verification needs of clinical laboratories running the Abbott ARCHITECT or Abbott ALINITY platform(s). The products (Order Nos. 701ab, 704ab, and 705ab respectively), which include analytes uric acid (UA), chloride (CL), ethyl alcohol (ETOH), glucose (GLU), potassium (K), sodium (NA), total protein (UTP), urea nitrogen (UUN), calcium (CA), creatinine (CREA), magnesium (MG), phosphorus (PHOS), micro-albumin (uALB), and amylase (AMY) are formulated in a human urine matrix, using the CLSI EP06-A “equal delta” sample preparation method, and provides five distinct concentrations across the claimed and extended range of the Abbott ARCHITECT or Abbott ALINITY instruments. VALIDATE UC1, VALIDATE UC4, and VALIDATE UC5 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 verify the assay’s reportable range.
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 regulatory 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 UC1, VALIDATE UC4, and VALIDATE UC5 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 150 analytes, including general chemistry, ACTH, anemia, body fluids, bone, cardiac, diabetes, fertility, hemostasis, osmolality, POC, sepsis, serum proteins, therapeutic drug monitoring, thyroid, tumor markers, and urine chemistry.
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.
To learn more, visit LGC Maine Standards.
¹LGC Maine Standards is the brand name for Maine Standards Company, LLC, and an entity of LGC Clinical Diagnostics Division.
Featured Image: The VALIDATE UC1 test kit is liquid and ready-to-use; simply dispense the solution from each dropper bottle, directly into five sample cups, and run in replicates to verify the assay’s reportable range. Photo: LGC Maine Standards