LGC Maine Standards Responds to the CAP Shipment Delay of LN2-A and LN2VM-A with Immediate Availability of VALIDATE® Linearity and Calibration Verification Kits

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Kits Allow Clinical Laboratories to Satisfy Requirements for Calibration Verification and Analytical Measurement Range (AMR) Verification

LGC Maine Standards confirms the immediate availability of VALIDATE® Linearity and Calibration Verification kits, which allow clinical laboratories to satisfy the requirements for calibration verification and analytical measurement range (AMR) verification as specified in the CAP Laboratory Accreditation Program (LAP) and current CLIA ‘88 Regulations, Section 493.1255.

On July 06, 2017, the College of American Pathologists (CAP) informed customers that the June 19th shipments of the LN2-A and LN2VM-A LN program were delayed and a date for delivery had not yet been published. As noted in the announcement, laboratories that have not verified calibration within the last 6 months need to perform an alternative assessment for calibration verification and AMR verification.

VALIDATE® kits, manufactured by LGC Maine Standards, satisfy these requirements and allow clinical laboratories to maintain compliance. VALIDATE® kits are liquid, ready-to-use and contain sufficient volume and open-vial stability to complete two testing cycles, plus troubleshooting, per instrument system. Therefore, a single order of VALIDATE® allows the clinical laboratory to recover from the CAP shipment delay and have material on- site for the December LN2-B and LN2VM-B test events.

The General Chemistry (GC1, GC2, GC3, GC4), Lipoprotein (LP), Cardiac Markers (CM1) and Osmolality (OSMO) kits cover all of the analytes within the LN2-A and LN2VM-A offering. Each kit is prepared using the CLSI EP06-A “equal delta” sample preparation and offer five distinct concentrations. Simply dispense the product from each dropper bottle, directly into five sample cups, and run in replicates.

VALIDATE® kits are available as instrument-specific configurations, tailor-made to specific analyzers, which maximize AMR coverage and minimize dilutions. Configurations are available for these and other automated chemistry systems: Abbott Laboratories, Beckman Coulter, Ortho Clinical Diagnostics, Roche Diagnostics and Siemens Healthineers. An order form is available at http://www.mainestandards.com/CAPdelay to afford laboratories a streamlined mechanism to access products for next-day shipments.

LGC Maine Standards MSDRx® data reduction software is also available at no charge for real-time linearity data analysis. A laboratory can also send their data to LGC Maine Standards where a technical specialist will complete the data analysis and return a report with Peer Data Comparison, within five business days.

Maine Standards remains committed to ensuring that high-quality linearity and calibration verification products are readily available to meet industry needs.

Contact: Maine Standards Company, LLC
221 US Route 1, Cumberland Foreside, ME 04110 1-207-892-1300 x73
MSC.Info(at)LGCGroup(dot)com http://www.mainestandards.com


About LGC
LGC is an international life sciences measurement and testing company with leading positions in growing markets. LGC provides a range of measurement products and services which underpin the safety, health and security of the public, including reference materials and proficiency testing, calibration verification / linearity testing, genomics reagents and instrumentation, and expert sample analysis and interpretation. LGC serves customers across a number of end markets including Pharmaceuticals, Agricultural Biotechnology, Food, Environment, Government and Academia.
LGC’s headquarters are in London and the company employs over 2,000 people, operating out of 22 countries worldwide. Its operations are extensively accredited to international quality standards such as ISO/IEC 17025, GMP, GLP, ISO Guide 34, ISO/IEC 17043 and ISO 13485:2003.

With a history dating back to 1842, LGC has been home to the UK Government Chemist for more than 100 years and is the UK National Measurement Laboratory and Designated Institute for chemical and bio measurement. LGC was privatized in 1996 and is now owned by funds affiliated with KKR. For more information, please visit http://www.lgcgroup.com
1LGC Maine Standards is the brand name for Maine Standards Company, LLC.

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Mary Beltrante
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