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Evaluation of the commutability of calibration and quality control materials for clinically relevant biomarkers

The commutability of a material represents its ability to mimic the behaviour of patient samples. For IVD manufacturers, the use of commutable standards is recommended by ISO 17511:2020 because the use of non-commutable standards causes calibration bias. For external quality assessement schemes, the use of commutable quality control materials allows evaluating the accuracy and comparability of different methods.

Presentation of possible services provided

Our laboratory offers the possibility to evaluate the commutability of your calibration and quality control materials for different biomarkers, matrices and assay methods. Contact us for a list of parameters offered.

Why choose LNE?

Through its participation in IFCC working groups and the organisation of various commutability studies (1-7), LNE has developed internationally recognised expertise in assessing the commutability of international standards and quality control materials.

For example, LNE was appointed by ANSM to produce and assess the commutability of control samples used in the National Quality Control organised in 2016 to evaluate the accuracy of some general biochemistry tests(8).

LNE also participated in the development of IFCC recommendations on the assessment of commutability (9-12).

Our publications:

  1. Delatour et al. Clin Chem. 2020;66(2):390-391
  2. Delatour et al. Clin Chem Lab Med. 2019;57(10):1623-1631
  3. Millet et al. Clin Chem. 2020;66(6):769-778
  4. Diepeveen et al., Clin Chem Lab Med. 2019;57(6):864-872
  5. Bargnoux et al. Clin Chem. 2017;63(4):833-841
  6. Bargnoux et al. Arch Pathol Lab Med. 2016;140(2):117-8
  7. Delatour et al. Clin Chem. 2016;62(12):1670-1671
  8. Contrôle National de Qualité des analyses de biologie médicale - Biochimie – Opération 16BIO1
  9. Miller et al. Clin Chem. 2018;64(3):447-454
  10. Nilsson et al. Clin Chem. 2018;64(3):455-464
  11. Budd et al. Clin Chem. 2018;64(3):465-474
  12. Miller et al. Clin Chim Acta. 2021;514:84-89