Braga F, Panteghini M. Verification of in vitro medical diagnostics (IVD) metrological traceability: responsibilities and strategies. Clin Chim Acta 2014;432:55–61.CrossrefWeb of SciencePubMedGoogle Scholar
JCGM 200:2012. International vocabulary of metrology – basic and general concepts and associated terms (VIM 3), 3rd ed. 2008 version with minor corrections. Sevres, France, 2012.Google Scholar
Dati F, Panteghini M, Apple FS, Christenson RH, Mair J, Wu AH. Proposals from the IFCC Committee on Standardization of Markers of Cardiac Damage (C-SMCD): strategies and concepts on standardization of cardiac marker assays. Scand J Clin Lab Invest Suppl 1999;230:113–23.PubMedGoogle Scholar
Infusino I, Frusciante E, Ferrero CA, Panteghini M. Commutability of two JCTLM-listed secondary reference materials for two commercial lithium assays. Clin Chim Acta 2012;414:152–3.PubMedCrossrefWeb of ScienceGoogle Scholar
Zegers I, Keller T, Schreiber W, Sheldon J, Albertini R, Blirup-Jensen S, et al. Characterization of the new serum protein reference material ERM-DA470k/IFCC: value assignment by immunoassay. Clin Chem 2010;56:1880–8.Web of SciencePubMedCrossrefGoogle Scholar
Infusino I, Braga F, Valente C, Panteghini M. Commutability of the ERM-DA470k reference material for two assays measuring serum albumin using immunochemical principles. Clin Chem Lab Med 2011;49:1383–4.PubMedWeb of ScienceGoogle Scholar
Braga F, Infusino I, Frusciante E, Ceriotti F, Panteghini M. Trueness evaluation and verification of interassay agreement of 11 serum IgA measuring systems: implications for medical decisions. Clin Chem 2019;65:473–83.CrossrefPubMedWeb of ScienceGoogle Scholar
Infusino I, Valente C, Dolci A, Panteghini M. Standardization of ceruloplasmin measurements is still an issue despite the availability of a common reference material. Anal Bioanal Chem 2010;397:521–5.PubMedWeb of ScienceCrossrefGoogle Scholar
Zegers I, Beetham R, Keller T, Sheldon J, Bullock D, MacKenzie F, et al. The importance of commutability of reference materials used as calibrators: the example of ceruloplasmin. Clin Chem 2013;59:1322–9.PubMedWeb of ScienceCrossrefGoogle Scholar
Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, et al. IFCC Working Group on Standardization of Thyroid Function Tests. Report of the IFCC Working Group for Standardization of Thyroid Function Tests; Part 1: Thyroid-stimulating hormone. Clin Chem 2010;56:902–11.CrossrefWeb of ScienceGoogle Scholar
ISO 15194:2009. In vitro diagnostic medical devices – measurement of quantities in samples of biological origin – Requirements for certified reference materials and content of supporting documentation. 2nd ed. Geneva, Switzerland: ISO, 2009.Google Scholar
ISO 17034:2016. General requirements for the competence of reference material producers. Geneva, Switzerland: ISO, 2016.Google Scholar
Panteghini M, Myers GL, Miller GW, Greenberg N. The importance of metrological traceability on the validity of creatinine measurement as an index of renal function. Clin Chem Lab Med 2006;44:1187–92.Google Scholar
Deprez L, Toussaint B, Zegers I, Schimmel H, Grote-Koska D, Klauke R, et al. Commutability assessment of candidate reference materials for pancreatic α-amylase. Clin Chem 2018;64:1193–202.CrossrefWeb of SciencePubMedGoogle Scholar
Andreasson U, Kuhlmann J, Pannee J, Umek RM, Stoops E, Vanderstichele H, et al. Commutability of the certified reference materials for the standardization of β-amyloid 1–42 assay in human cerebrospinal fluid: lessons for tau and β-amyloid 1–40 measurements. Clin Chem Lab Med 2018;56:2058–66.CrossrefWeb of SciencePubMedGoogle Scholar
CLSI. Characterization and qualification of commutable reference materials for laboratory medicine; Approved guideline. Document EP30-A (formerly C53-A). Wayne, PA: Clinical and Laboratory Standards Institute, 2010.Google Scholar
CLSI. Evaluation of commutability of processed samples: approved guideline – 3rd ed. Document EP14-A3. Wayne, PA: Clinical and Laboratory Standards Institute, 2014.Google Scholar
Miller WG, Schimmel H, Rej R, Greenberg N, Ceriotti F, Burns C, et al. for the IFCC Working Group on Commutability. IFCC working group recommendations for assessing commutability. Part 1: General experimental design. Clin Chem 2018;64:447–54.CrossrefGoogle Scholar
Nilsson G, Budd JR, Greenberg N, Delatour V, Rej R, Panteghini M, et al. IFCC working group recommendations for assessing commutability. Part 2: Using the difference in bias between a reference material and clinical samples. Clin Chem 2018;64:455–64.CrossrefWeb of ScienceGoogle Scholar
Budd JR, Weykamp C, Rej R, MacKenzie F, Ceriotti F, Greenberg N, et al. for the IFCC Working Group on Commutability. IFCC working group recommendations for assessing commutability. Part 3: Using the calibration effectiveness of a reference material. Clin Chem 2018;64:465–74.Web of ScienceCrossrefGoogle Scholar
Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G,Oosterhuis W, et al. Defining analytical performance specifications: Consensus Statement from the 1st Strategic Conference of the European Federation of Clinical Chemistry and Laboratory Medicine. Clin Chem Lab Med 2015;53:833–5.PubMedWeb of ScienceGoogle Scholar
Panteghini M. Application of traceability concepts to analytical quality control may reconcile total error with uncertainty of measurement. Clin Chem Lab Med 2010;48:7–10.PubMedWeb of ScienceGoogle Scholar
Braga F, Pasqualetti S, Panteghini M. The role of external quality assessment in the verification of in vitro medical diagnostics in the traceability era. Clin Biochem 2018;57:23–8.PubMedWeb of ScienceCrossrefGoogle Scholar
Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670–80.PubMedWeb of ScienceCrossrefGoogle Scholar
CLSI. Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures: approved guideline. Document C37-A. Wayne, PA: Clinical and Laboratory Standards Institute, 1999.Google Scholar
Jones GRD, Albarede S, Kesseler D, MacKenzie F, Mammen J, Pedersen M, et al. EFLM Task Finish Group – Analytical Performance Specifications for EQAS (TFG-APSEQA). Analytical performance specifications for external quality assessment – definitions and descriptions. Clin Chem Lab Med 2017;55:949–55.PubMedGoogle Scholar
Stepman HC, Tiikkainen U, Stöckl D, Vesper HW, Edwards SH, Laitinen H, et al. Measurements for 8 common analytes in native sera identify inadequate standardization among 6 routine laboratory assays. Clin Chem 2014;60:855–63.PubMedWeb of ScienceCrossrefGoogle Scholar
Weykamp C, Secchiero S, Plebani M, Thelen M, Cobbaert C, Thomas A, et al. Analytical performance of 17 general chemistry analytes across countries and across manufacturers in the INPUtS project of EQA organizers in Italy, the Netherlands, Portugal, United Kingdom and Spain. Clin Chem Lab Med 2017;55:203–11.Web of SciencePubMedGoogle Scholar
Kristensen GB, Rustad P, Berg JP, Aakre KM. Analytical bias exceeding desirable quality goal in 4 out of 5 common immunoassays: results of a native single serum sample external quality assessment program for cobalamin, folate, ferritin, thyroid-stimulating hormone, and free T4 analyses. Clin Chem 2016;62:1255–63.CrossrefPubMedWeb of ScienceGoogle Scholar
Braga F, Infusino I, Panteghini M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med 2015;53:905–12.Web of SciencePubMedGoogle Scholar
Hage-Sleiman M, Capdevila L, Bailleul S, Lefevre G. High-sensitivity cardiac troponin-I analytical imprecisions evaluated by internal quality control or imprecision profile. Clin Chem Lab Med 2019;57:e49–51.Web of ScienceCrossrefPubMedGoogle Scholar
About the article
Published Online: 2019-03-23
Published in Print: 2019-06-26
Author contributions: All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.
Research funding: None declared.
Employment or leadership: None declared.
Honorarium: None declared.
Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.