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Calibration of medical biology analyzers and verification of the accuracy of IVD assays for clinically relevant biomarker measurements

Calibrating your instruments with reference methods or reference materials allows establishing the metrological traceability of results, as required by ISO 15189 and 17511, as well as by the 2017/746 regulation on in vitro diagnostic medical devices. Having quality control samples whose target values have been determined with a reference method also allows you to verify the accuracy of the measurements.

Available calibrations

  • Measurement of glucose by GC-IDMS in serum and calibration solutions with a concentration between 1.6 and 20 mmol/L.
    Expanded relative uncertainty between 1 and 3%
  • Measurement of creatinine by LC-IDMS in serum and calibration solutions with a concentration between 25 and 500 µmol/L
    Expanded relative uncertainty between 1 and 3%
  • Measurement of triglyceride by GC-IDMS in serum and calibration solutions with a concentration between 0.8 and 8 mmol/L
    Expanded relative uncertainty between 1 and 4%
  • Measurement of total cholesterol by GC-IDMS in serum and calibration solutions with a concentration between 1 and 10 mmol/L
    Expanded relative uncertainty between 2 and 5%
  • Measurement of LDL-cholesterol by Beta-Quantification in serum samples with a concentration between 1 and 10 mmol/L
    Expanded relative uncertainty between 2 and 5%
  • Measurement of HDL-cholesterol by Beta-Quantification in serum samples with a concentration between 1 and 10 mmol/L
    Expanded relative uncertainty between 2 and 5%
  • Measurement of HbA1c by the IFCC reference method by LC/MS in whole blood samples or haemolysates with a concentration between 20 and 150 mmol/mol
    Expanded uncertainty of 1 to 4 mmol/mol
  • Measurement of amino acids (Alanine, Leucine, Isoleucine, Phenylalanine, Valine, Proline) in solutions with concentrations between 0.5 and 500 µg/g
    Broader relative uncertainty between 1 and 3 %
  • Measurement of peptides by amino acid analysis in solutions with a concentration between 25 and 500 µmol/L
    Expanded relative uncertainty between 5 and 10%

Accreditations and recognitions

  • Calibration services performed under COFRAC accreditation according to ISO 15195 and ISO 17025 (COFRAC calibration accreditation n°2-54).
  • Recognition by the JCTLM as a reference laboratory for the determination of glucose, creatinine, total cholesterol, LDL-cholesterol and HDL-cholesterol in human serum, as well as HbA1c in haemolysates.
  • Expertise recognised by a CMC (Calibration and Measurement Capability) for the determination of glucose, creatinine and total cholesterol in human serum and by a CDC certification for the measurement of total cholesterol by GC-IDMS.

Why choosing LNE?

  • Metrological traceability of results to SI units achieved through the use of primary reference standards of certified purity or certified reference materials.
  • Accuracy of the reference method verified by the use of certified matrix reference materials.
  • Use of high-accuracy reference methods listed in the JCTLM database, which allows calibrations with measurement uncertainties at world-class level.
  • Regular participation in inter-laboratory comparisons at the highest level (CCQM, IFCC RELA, CRMLN).
  • Only calibration laboratory listed in the JCTLM database for the determination of cHDL and cLDL.
  • Member of the CRMLN (Cholesterol Reference Method Laboratory Network).