Biennial activity report from Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan

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1 Biennial activity report from Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan Organization: Research Centre for Metrological Traceability in Laboratory Medicine (CIRME), University of Milan, Milan, Italy JCTLM Member status: JCTLM Stakeholder Member Author(s): Prof Mauro Panteghini, CIRME Scientific Coordinator Author(s) (s): Period covered: Major achievements in support of standardization in laboratory medicine 1. Accreditation of reference laboratory services for the following measurands (all listed in the JCTLM database): ALT, ALP, AST, CK, GGT, LDH, Glucose, HbA1c. 2. Participation to the campaign for value assignment using the IFCC Reference Procedure for LDH, CK and ALT ERM-AD453/454/455k European Commission Joint Research Centre. 3. Many other activities related to the validation and verification of IDV measuring systems as described in the following papers published in peer-reviewed journals: 1. Lippi G, Banfi G, Church S, et al. European Federation for Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase. Preanalytical quality improvement. In pursuit of harmony, on behalf of European Federation for Clinical Chemistry and Laboratory Medicine (EFLM) Working group for Preanalytical Phase (WG- PRE). Clin Chem Lab Med 2015;53: Simundic AM, Cornes MP, Grankvist K et al. Colour coding for blood collection tube closures - a call for harmonisation. Clin Chem Lab Med. 2015;53: Tate JR, Bunk DM, Christenson RH, et al. Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project. Clin Chem Lab Med 2015;53: Panteghini M, Sandberg S. Defining analytical performance specifications 15 years after the Stockholm conference. Clin Chem Lab Med 2015;53: Ceriotti F, Kaczmarek E, Guerra E, Mastrantonio F, Lucarelli F, Valgimigli F, Mosca A Comparative performance assessment of point-of-care testing devices for measuring glucose and ketones at the patient bedside. J Diabetes Sci Technol 2015;9: Sandberg S, Fraser CG, Horvath AR, Jansen R, Jones G, Oosterhuis W, Petersen PH, Schimmel H, Sikaris K, Panteghini M. 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: Braga F, Infusino I, Panteghini M. Performance criteria for combined uncertainty budget in the implementation of metrological traceability. Clin Chem Lab Med 2015;53: Pasqualetti S, Infusino I, Carnevale A, Szőke D, Panteghini M. The calibrator value assignment protocol of the Abbott enzymatic creatinine assay is inadequate for ensuring suitable quality of serum measurements. Clin Chim Acta 2015;450: Topic E, Nikolac N, Panteghini M, et al. How to assess the quality of your analytical method? Clin Chem Lan Med 2015;53: September 2017, V

2 10. Braga F, Ferraro S, Ieva F, et al. A new robust statistical model for interpretation of differences in serial results from an individual. Clin Chem Lab Med 2015;53: Mosca A, Paleari R, Carobene A, Weykamp C, Ceriotti F. Performance of glycated hemoglobin (HbA(1c)) methods evaluated with EQAS studies using fresh blood samples: Still space for improvements. Clin Chim Acta 2015;451: Szőke D, Carnevale A, Pasqualetti S, Braga F, Paleari R, Panteghini M. More on the accuracy of the Architect enzymatic assay for hemoglobin A1c and its traceability to the IFCC reference system. Clin Chem Lab Med 2016;54:e Braga F, Pasqualetti S, Ferraro S, Panteghini M. Hyperuricemia as risk factor for coronary heart disease incidence and mortality in the general population: a systematic review and meta-analysis. Clin Chem Lab Med 2016;54: Panteghini M, Sandberg S. Total error vs. measurement uncertainty: the match continues. Clin Chem Lab Med 2016;54: Braga F, Panteghini M. Generation of data on within-subject biological variation in laboratory medicine: An update. Crit Rev Clin Lab Sci 2016;53: Ferraro S, Borille S, Carnevale A, Frusciante E, Bassani N, Panteghini M. Verification of the harmonization of human epididymis protein 4 assays. Clin Chem Lab Med 2016;54: Paleari R, Strollo M, Guerra E, Ceriotti F, Mosca A. Glycation gap: An additional tool for glycometabolic monitoring. Clin Chim Acta 2016;463: Paleari R, Caruso D, Kaiser P, et al.; IFCC Working Group on Standardisation of Hemoglobin A2 (WG-HbA2). Developing a reference system for the IFCC standardization of HbA2. Clin Chim Acta Ceriotti F, Fernandez-Calle P, Klee GG, Nordin G, Sandberg S, Streichert T, Vives-Corrons JL, Panteghini M; EFLM Task and Finish Group on Allocation of laboratory tests to different models for performance specifications (TFG-DM). Criteria for assigning laboratory measurands to models for analytical performance specifications defined in the 1st EFLM Strategic Conference. Clin Chem Lab Med 2017;55: Infusino I, Frusciante E, Braga F, Panteghini M. Progress and impact of enzyme measurement standardization. Clin Chem Lab Med 2017;55: Braga F, Frusciante E, Infusino I, Aloisio E, Guerra E, Ceriotti F, Panteghini M. Evaluation of the trueness of serum alkaline phosphatase measurement in a group of Italian laboratories. Clin Chem Lab Med 2017;55:e Pasqualetti S, Braga F, Panteghini M. Pre-analytical and analytical aspects affecting clinical reliability of plasma glucose results. Clin Biochem 2017;50: Pasqualetti S, Panteghini M. Clinical impact of glycolysis inhibition on plasma glucose results requires caution. Ann Clin Biochem 2017;54: Jones GRD, Albarede S, Kesseler D, MacKenzie F, Mammen J, Pedersen M, Stavelin A, Thelen M, Thomas A, Twomey PJ, Ventura E, Panteghini M, for the 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: Panteghini M, Adeli K, Ceriotti F, Sandberg S, Horvath AR. American liver guidelines ans cutoffs for "normal" ALT: A potential for overdiagnosis. Clin Chem 2017;63: Ferraro S, Panzeri A, Panteghini M. Tackling serum folate test in European countries within the health technology assessment paradigm: request appropriateness, assays and health outcomes. Clin Chem Lab Med 2017;55: September 2017, V

3 27. Ferraro S, Panzeri A, Borille S, Szoke D, Panteghini M. Estimation of the reference interval for serum folate measured with assays traceable to the WHO International Standard. Clin Chem Lab Med 2017;55:e Panteghini M, Ceriotti F, Jones G, Oosterhuis W, Plebani M, Sandberg S; Task Force on Performance Specifications in Laboratory Medicine of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM). Strategies to define performance specifications in laboratory medicine: 3 years on from the Milan Strategic Conference. Clin Chem Lab Med 2017;55: Planned activities in support of standardization in laboratory medicine The main activities of CIRME are: Characterization and certification of reference materials Evaluation of commutability of reference and calibration materials Value targeting of EQA materials Validation of traceability of commercial IVD systems Promoting traceability in laboratory medicine 1. See list of publications above. 2. Organization of International CIRME Meetings: a. 9th International Scientific Meeting, Structuring EQAS for meeting metrological criteria: ready for prime time b. 10th International Scientific Meeting, CIRME - Ten years after c. 11th International Scientific Meeting, Measurement uncertainty in medical laboratories: friend or foe? 3. Organization of a symposium entitled "Traceability in laboratory medicine: a matter of patient safety" at the 22 nd IFCC-EFLM EuroMedLab, June 2017, Athens (Greece) 4. Presentations on traceability at the following international and national conferences or congresses: a. Verification of IVD metrological traceability: responsibilities and strategies in the EU context. Conference on Laboratory diagnostics - past, present and future (Kielce, Polonia, February 6th, 2015) M. Panteghini b. Verification of in vitro medical diagnostics (IVD) metrological traceability: role and responsibilities of laboratory medicine specialists in the EU context. EFLM Symposium on Education in Clinical Chemistry and Laboratory Medicine (Prague, Czech Republic, April 25th, 2015) M. Panteghini c. Verification of in vitro medical diagnostics (IVD) metrological traceability: role and responsibilities of laboratory medicine specialists. 11th EFLM Symposium for Balkan Region. (Belgrade, Serbia, May 14, 2015) M. Panteghini d. Plenary Lecture: Defining analytical performance specifications. Malaysian Association of Clinical Biochemistry 2015 Conference (Kuala Lumpur, Malaysia, 4 August 2015) M. Panteghini e. Plenary Lecture: Global harmonization in laboratory medicine. 8th Congress of the Croatian society of medical biochemistry and laboratory medicine (Rijeka, Croatia, 23 September 2015) M. Panteghini f. Opening Lecture: Defining performance specifications in laboratory testing. 23rd Meeting of the Balkan Clinical Laboratory Federation (Sarajevo, Bosnia & Herzegovina, October 7, 2015) M. Panteghini September 2017, V

4 g. Plenary Lecture: Performance criteria for measurement methods and reference materials in clinical analyses. 14th International Symposium on Biological and Environmental Reference Materials (National Harbor, Maryland, USA, October 13, 2015) M. Panteghini h. Who, what and when to do validation/verification of methods. 15th EFLM Continuous Postgraduate Course in Clinical Chemistry and Laboratory Medicine (Zagreb, Croatia, October 24, 2015) M. Panteghini i. How to assess the quality of your method? (Zagreb, Croatia, October 24, 2015) I. Infusino j. Harmonization of laboratory testing in Europe and at the global level. 13th Hellenic Congress of Clinical Chemistry (Heraklion, Crete, October 29, 2015) M. Panteghini k. Verification of in vitro medical diagnostics (IVD) metrological traceability: Role and responsibilities of laboratory medicine specialists. 6th International Conference on Quality of Medical Laboratories (Ljubljana, Slovenia, December 4, 2015) M. Panteghini l. Allowable limits for measurement uncertainty across the traceability chain. Quality in the Spotlight Conference Quality 2016 (Antwerp, Belgium, March 14, 2016) M. Panteghini m. Quality and calibration aspects of biochemical methods. Clinical Chemistry Spring Meeting 2016 (Malmoe, Sweden, May 11, 2016) M. Panteghini n. Progress and impact of enzyme measurement standardization. Protein and Peptide Therapeutics and Diagnostics: Research and Quality Assurance. International Workshop PPTD-2016 (Chengdu, China, June 3, 2016) M. Panteghini o. Promoting clinical and laboratory interaction by harmonization. 4th Joint EFLM- UEMS Congress (Warsaw, Poland, September 23, 2016) M. Panteghini p. Standardization in Laboratory Medicine: progresses, barriers and solutions. Workshop on Standardization of Clinical Laboratory Testing. (Shanghai, China, October 19, 2016) M. Panteghini q. Implementation of metrological traceability in agreement with EU IVD Directive to improve comparability of laboratory results. 14th Asia Pacific Federation for Clinical Biochemistry and Laboratory Medicine Congress 2016 (APFCB Congress 2016) (Taipei, Taiwan, November 28, 2016) M. Panteghini r. Roles and responsibilities in verification of traceability of in vitro medical diagnostics (IVD). Federica Braga. EuroMedlLab Athens 2017, June s. Progress and impact of enzyme measurement standardization. Ilenia Infusino, EuroMedlLab Athens 2017, June 2017 t. Traceability of HbA1c measurements: weak and strong points. Andrea Mosca, EuroMedlLab Athens 2017, June 2017 u. Defining performance specifications in laboratory testing. 22nd IFCC-EFLM European Congress of Clinical Chemistry and Laboratory Medicine (Athens, Greece, June 14, 2017) M. Panteghini v. The role of EQA in the verification of in-vitro medical diagnostics. EQALM Symposium 2017 (Dublin, Ireland, October 19, 2017) M. Panteghini w. Performance specifications. International Conference on Laboratory Medicine. Uncertainty, quality, safety and accreditation in laboratory medicine (Padova, Italy, October 26, 2017) M. Panteghini September 2017, V

5 Collaborations focusing on developing /implementing reference measurement systems Participation as member in: 1. ISO/TC 212 WG2 2. JCTLM WG-DB and related RTs (Enzymes and Proteins) 3. IFCC Committee on Traceability in Laboratory Medicine 4. IFCC WG on Commutability 5. IFCC WG on Standardization of Troponin I 6. IFCC WG on Standardization of HbA2 7. IFCC WG on Standardization of Albumin Assay in Urine 8. EFLM Task Force on Performance Specifications in Laboratory Medicine 9. EFLM Task and Finish Group on Allocation of laboratory tests to different models for performance specifications 10. EFLM Task and Finish Group on Analytical Performance Specifications for EQAS 11. EFLM WG on Biological Variability and Task and Finish Group on Biological Variability Database Suggestions to be addressed by JCTLM 1. Definition and approval of reference measurement systems, in their entirety and not just in their main components (reference materials and methods). 2. Promote the implementation by IVD industry of traceability to such reference systems in a scientifically sound and transparent way, i.e. they should include in their assay or calibrator package inserts: a. an indication of higher order references (materials and/or procedures) used to assign traceable values to calibrators, b. which internal calibration hierarchy has been applied by the manufacturer, and a detailed description of each step, c. the expanded combined uncertainty value of commercial calibrators, and which, if any, acceptable limits for uncertainty of calibrators were applied in the validation of the measuring system. September 2017, V