CUMBERLAND FORESIDE, Maine,
April 8, 2021 /PRNewswire/ -- LGC
Maine Standards¹ announces a product update for
VALIDATE® Diabetes which meets the linearity and
calibration verification needs of clinical laboratories running the
Roche cobas® platform. The product (Order No.
204RO), which includes the analytes beta-hydroxybutyrate
(BHB)*, C-peptide (C-PEP), Fructosamine (FRUC), Insulin (INS), and
now Glucose (GLU), is formulated in a human serum matrix, using the
CLSI EP06-A "equal delta" sample preparation method, and provides
five distinct concentrations across the claimed range of the Roche
cobas® instrument. VALIDATE® Diabetes 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.
When combined with Micro-Albumin (µALB) in
VALIDATE® UC5 (705RO), Glycohemoglobin A1c
(HbA1c) in VALIDATE® HbA1c (605), and High
Density Lipoprotein (HDL) and Low Density Lipoprotein (LDL) in
VALIDATE® LP (501RO), laboratories can challenge
the reportable range of Roche cobas® Diabetes-related
VALIDATE® Diabetes is FDA listed and offers five
Levels of complete reportable range coverage – eliminating the need
for manual dilutions! 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 control 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.
With the addition of Glucose to VALIDATE® Diabetes,
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 Chemistries, 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.
For VALIDATE® Diabetes
product details click here or call 1-800-377-9684.
¹LGC Maine Standards is the brand name for Maine Standards
Company, LLC, and an entity of LGC Clinical Diagnostics
*Developed and manufactured using Stanbio's BHB reagent on the
About LGC Clinical Diagnostics
Diagnostics Division develops and manufactures a comprehensive
portfolio of catalog and custom-developed diagnostic quality
solutions and component materials for the extended life sciences
industry. We partner with IVD assay developers, and pharmaceutical,
CRO and academic institutions in commercialization activities
across the entire diagnostic pipeline - from concept and early
stage research, through expedited product development and onwards
into routine clinical use. Laboratorians and diagnostic
professionals across disciplines of clinical chemistry,
immunochemistry, serology, molecular diagnostics and clinical
genomics rely on LGC's products to support accurate and reliable
Our operating entities include SeraCare Life Sciences and Maine
Standards Company, which are in vitro diagnostics (IVD)
manufacturers of quality measurement tools (calibrators, controls,
linearity, EQA/PT, biological materials) and The Native Antigen
Company, which is a manufacturer and supplier of viral antigens.
Our 300+ employees operate FDA-registered and ISO 13485-accredited
facilities in Maine, Massachusetts and Maryland, USA, and an ISO 9001-accredited
facility in Oxford, UK.
Each day, our world-class staff, scientific expertise,
operational efficiency and superior quality systems are ready to
support the range of advanced technologies that collectively
improve patient outcomes - from the widely adopted and established
through to cutting-edge NGS and precision diagnostics.
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SOURCE LGC Maine Standards