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Tag Archives: LGC Maine Standards

Validate kits for Roche, Siemens analyzers

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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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