January 2020—LGC Maine Standards released its Validate LP2 linearity and calibration verification kits for Roche Cobas analyzers. The kits evaluate apolipoprotein A (Apo-A1) and apolipoprotein B (Apo-B). Validate SP1 linearity and calibration verification kits, specifically targeted for Roche Cobas and Roche Cobas Integra analyzers, were also released. The kits evaluate α1-antitrypsin, complement C3, complement C4, immunoglobulin A, immunoglobulin G, immunoglobulin M, and transferrin. The Validate LP2 and SP1 kits are in a human serum matrix.
Read More »Validate kits for Roche, Beckman
August 2019—LGC Maine Standards released its Validate SP3 linearity and calibration verification kit for Roche Cobas and Beckman Coulter Immage analyzers. The kit, in a human serum matrix, evaluates α1-acid glycoprotein, antistreptolysin O, B2-microglobulin, and immunoglobulin E.
Read More »Validate LP for Siemens Advia, Atellica
July 2019—LGC Maine Standards launched its Validate LP linearity and calibration verification kit for Siemens Healthineers Advia and Atellica analyzers.
Read More »Validate CSF total protein kit
April 2019—LGC Maine Standards has added Cerebrospinal Fluid Total Protein to its Validate Body Fluids kit for laboratory-developed test validation, documentation of linearity, calibration verification, and verification of the reportable range.
Read More »Body fluids kit
December 2018—LGC Maine Standards has released its Validate Body Fluids kit, 205bf. The kit, in a simulated body fluid matrix, will assist in the documentation of linearity, calibration verification, and verification of the reportable range for albumin, amylase, cholesterol, creatinine, glucose, lactate, lactate dehydrogenase, total protein 2, triglycerides, and urea nitrogen.
Read More »Validate CM2 kit for Ortho Vitros
December 2018—LGC Maine Standards released its Validate CM2 linearity and calibration verification kit for Ortho Vitros analyzers.
Read More »Validate kits for Roche Cobas, Siemens Sysmex
October 2018—LGC Maine Standards announced the release of its Validate hsTnT kit for Roche Cobas. The kit, in a human serum matrix, is a linearity and calibration verification product that targets Roche’s Troponin T Gen 5 Stat (TnTG5) assay range.
Read More »Validate IBC for Ortho Vitros analyzers
September 2018—LGC Maine Standards’ Validate IBC linearity and calibration verification kit for Ortho Vitros analyzers is now available. The liquid, ready-to-use kit, in a human serum matrix, evaluates total iron binding capacity.
Read More »Validate Procalcitonin Kit for Architect analyzers
August 2018—LGC Maine Standards released its Validate Procalcitonin linearity and calibration verification kit for Abbott Architect analyzers.
Read More »Expanded use of Validate Fibrinogen kit
July 2018—LGC Maine Standards announced that its Validate Fibrinogen for linearity and calibration verification is available on Instrumentation Laboratory’s ACL Top 500, Siemens Healthineers’ Sysmex CS-2500, and Diagnostica Stago’s STA-R Evolution hemostasis test systems.
Read More »Validate body fluids kit
June 2018—LGC Maine Standards released its Validate Body Fluids, a comprehensive body fluids kit for linearity and calibration verification.
Read More »FT3 added to Validate THY kit, 4/18
April 2018—LGC Maine Standards announced it has enhanced the Validate THY linearity and calibration verification kit by adding free triiodothyronine (FT3) as a component of total triiodothyronine (TT3).
Read More »Validate verification kits, 4/18
April 2018—LGC Maine Standards released two Validate linearity and calibration verification kits. The Validate Procalcitonin kit for Roche Cobas analyzers is in a human-serum matrix. The Validate HbA1c kit is for Tosoh analyzers and is in a human, whole blood matrix.
Read More »Heparin test kit for Stago STA analyzers, 3/18
March 2018—LGC Maine Standards announced the release of its Validate Heparin linearity and calibration verification kit. The Validate Heparin kit evaluates heparin anti-Xa activity in a human plasma matrix and is prepared using CLSI’s EP06-A recommended equal delta method for linearity testing.
Read More »Validate kits for Roche, Abbott analyzers, 2/18
February 2018—LGC Maine Standards announced the release of its Validate SP2 linearity and calibration verification kit. The Validate SP2 kit, in a human serum matrix, evaluates albumin, ceruloplasmin, C-reactive protein, haptoglobin, prealbumin, and rheumatoid factor. Each kit offers five distinct concentrations covering the reportable ranges of Roche Cobas analyzers.
Read More »D-dimer kit for Siemens Sysmex CS-2500 analyzers, 9/17
September 2017—LGC Maine Standards’ Validate D-Dimer linearity and calibration verification test kit has received FDA 510(k) clearance for use on Siemens Sysmex CS-2500 System analyzers.
Read More »Heparin calibration verification/linearity test kit, 6/17
June 2017—LGC Maine Standards’ Validate Heparin calibration verification/linearity test kit received FDA 510(k) clearance for use on Instrumentation Laboratory’s ACL TOP 500 hemostasis test systems. The Validate Heparin kit evaluates heparin anti-Xa activity in a human plasma matrix, is prepared using CLSI’s EP06-A recommended equal delta method for linearity testing, and is liquid, ready to use.
Read More »Rheumatoid factor added to linearity kit, 4/17
March 2017—LGC Maine Standards added rheumatoid factor to its Validate SP2 calibration verification/linearity test kit. Validate SP2 evaluates albumin, C-reactive protein, haptoglobin, prealbumin, and rheumatoid factor in a human serum base. Each kit is prepared using the CLSI-recommended “equal delta” method for linearity testing and is liquid, ready to use.
Read More »D-dimer test kit approved for Stago analyzer, 3/17
March 2017—LGC Maine Standards’ Validate D-Dimer calibration verification/linearity test kit received FDA 510(k) clearance for use on Stago STA-R Evolution analyzers.
Read More »D-Dimer test kit, 10/16
October 2016—LGC Maine Standards announced its Validate D-Dimer calibration verification/linearity test kit has received 510(k) clearance for use on Instrumentation Laboratory’s ACL Top hemostasis test systems.
Read More »Calibration verification/linearity test kits, 9/16
September 2016—LGC Maine Standards released its Validate Tumor Markers and Validate Whole Blood Glucose calibration verification/linearity test kits.
Read More »D-dimer test kit, 8/16
August 2016—LGC Maine Standards announced its Validate D-Dimer calibration verification/linearity test kit has received 510(k) clearance for use on Instrumentation Laboratory’s ACL TOP hemostasis test systems. The kit evaluates D-dimer in a human-plasma base matrix, is prepared using the CLSI recommended “equal delta” method for linearity testing, and is liquid, ready to use.
Read More »Calibration verification/linearity test kit, 11/15
November 2015—Maine Standards released its Validate SP2 calibration verification/linearity test kit, which evaluates albumin, C-reactive protein, haptoglobin, and prealbumin in a human-serum–based matrix.
Read More »Anemia calibration verification/linearity test kit, 10/15
Maine Standards Company released its Validate Anemia calibration verification/linearity test kit. The kit contains ferritin, folate, and vitamin B12 in a human-serum base matrix.
Read More »HbA1c calibration verification and linearity test kit, 9/15
Maine Standards released its Validate HbA1c calibration verification/linearity test kit. The kit evaluates percentage of glycohemoglobin A1c in a human-whole-blood base matrix. Each kit is prepared using the CLSI recommended “equal delta” method for linearity testing and is liquid and ready to use—add the product from the dropper bottle directly into a sample cup and run as a patient sample in duplicate or triplicate.
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