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References
- Update on current concepts and meanings in laboratory medicine: standardization, traceability and harmonization.Clin Chim Acta. 2014; 432: 49-54
- Harmonization of clinical laboratory test results: the role of the IVD industry.EJIFCC. 2016; 27: 37-47
- Roadmap for harmonization of clinical laboratory measurements procedures.Clin Chem. 2011; 57: 1108-1117
- Harmonization of laboratory testing- current achievements and future strategies.Clin Chim Acta. 2014; 432: 4-7
- Patient safety and clinical effectiveness as imperatives for achieving harmonization inside and outside the clinical laboratory.Clin Chem. 2011; 57: 936-938
- Metrological traceability in clinical biochemistry.Ann Clin Biochem. 2011; 48: 393-409
- Commutability still matters.Clin Chem. 2013; 59: 1291-1293
- Adding value to laboratory medicine: a professional responsibility.Clin Chem Lab Med. 2013; 51: 221-227
- Harmonisation of measurement procedures: how do we get it done?.Clin Biochem Rev. 2012; 33: 95-100
- A jumpstart on harmonization.Clinical Laboratory News. 2010; 36: 12
- Challenges and opportunities for medical directors in pathology and laboratory medicine.Am J Clin Pathol. 2010; 133: 8-13
- Between-method differences in prostate-specific antigen assays affect prostate cancer risk prediction by nomograms.Clin Chem. 2011; 57: 995-1004
- Traceability as a unique tool to improve standardization in laboratory medicine.Clin Biochem. 2009; 42: 236-240
- The Joint Committee on Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardization of clinical laboratory results.Clin Biochem. 2007; 28: 105-113
- Traceability and standardization of immunoassays: a major challenge.Clin Biochem. 2009; 42: 241-245
- Planning report 04-1, the impact of calibration error in medical decision making.National Institute for Standards and Technology, Gaithersburg (MD)2004
- The ‘70% claim’: what is the evidence base?.Ann Clin Biochem. 2011; 48: 487-488
- Harmonization of laboratory testing- a global activity.Clin Chim Acta. 2014; 432 ([Editorial]): 1-3
- Evaluation of a next generation direct whole blood enzymatic assay for hemoglobin A1c on the ARCHITECT c8000 chemistry system.Clin Chem Lab Med. 2015; 53: 125-132
- Burtis C.A. Ashwood E.R. Tietz textbook of clinical chemistry. 3rd edition. W.B. Saunders Co, Philadelphia1999
- Burtis C.A. Ashwood E.R. Bruns D.E. Tietz textbook of clinical chemistry and molecular diagnostics. 4th edition. W.B. Saunders Co, Philadelphia2006
- Burtis C.A. Ashwood E.R. Bruns D.E. Tietz textbook of clinical chemistry and molecular diagnostics. 5th edition. W.B. Saunders Co, Philadelphia2011
- Metrological traceability of measurement results in chemistry: concepts and implementation. IUPAC Technical Report.Pure Appl Chem. 2011; 83: 1873-1935
- The IVD directive and availability of reference systems for IVD medical devices: a view from Industry.IVD Technology. 2001; 7: 18-27
- Traceability of assay calibrators: the EU’s IVD Directive raises the bar.IVD Technology. 2000; (July – August)
- Traceability in laboratory medicine.Clin Chem. 2009; 55: 1067-1075
- In vitro diagnostic medical devices - measurement of quantities in biological samples - metrological traceability of values assigned to calibrators and control materials.International Organization for Standardization, Geneva, Switzerland2003
- Medical laboratories — requirements for quality and competence.International Organization for Standardization, 2012
- Expression of measurement uncertainty in laboratory medicine.Clinical Laboratory Standards Institute, Wayne (PA)2012
- From total allowable error via metrological traceability to uncertainty of measurement of the unbiased result.Accred Qual Assur. 1999; 4: 401-405
- Measurement traceability and US IVD manufacturers: the impact of metrology.Accred Qual Assur. 2009; 14: 393-398
- Traceability, reference systems and result comparability.Clin Biochem Rev. 2007; 28: 97-104
- Verification of in vitro medical diagnostics (IVD) metrological traceability: responsibilities and strategies.Clin Chim Acta. 2014; 432: 55-61
Available at: www.bipm.org/jctlm. Accessed March 19, 2016.
- Reference materials and reference measurement procedures: an overview from a national metrology institute.Clin Biochem Rev. 2007; 28: 131-137
- A discussion of enzyme reference materials: applications and specifications.Clin Chem. 1973; 19: 5-9
- Accurate enzyme activity measurements.Arch Pathol Lab Med. 1993; 117: 352-364
- Proficiency testing external quality assessment: current challenges and future directions.Clin Chem. 2011; 57: 1670-1680
- Why commutability matters.Clin Chem. 2006; 52: 553-554
- Characterization and qualification of commutable reference materials for laboratory medicine.Clinical Laboratory Standards Institute, Wayne (PA)2010
- Proficiency testing matters.Clin Chem. 2013; 59: 335-337
- State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry.Arch Pathol Lab Med. 2008; 132: 838-846
- The role of proficiency testing in achieving standardization and harmonization between laboratories.Clin Biochem. 2009; 42: 232-235
- Trueness verification and traceability assessment of results from commercial systems for measurement of six enzyme activities in serum: an international study in the EC4 framework of the Calibration 2000 project.Clin Chim Acta. 2006; 368: 160-167
- The need for standardization of tacrolimus assays.Clin Chem. 2011; 57: 1739-1747
- Harmonization in laboratory medicine: the complete picture.Clin Chem Lab Med. 2013; 51: 741-751
- Accuracy in clinical chemistry- Who will kiss Sleeping Beauty awake?.Clin Chem. 2008; 46: 1220-1222
- Defining acceptable limits for the metrological traceability of specific measurands.Clin Chem Lab Med. 2013; 51: 973-976
- Pathology Harmony; a pragmatic and scientific approach to unfounded variation in the clinical laboratory.Ann Clin Biochem. 2011; 48: 195-197
- Standardisation of test requesting and reporting for the electronic health record.Clin Chim Acta. 2014; 432: 148-156
- Haromonisation of laboratory testing.Clin Biochem Rev. 2012; 33: 81-84
- The Joint Committee for Traceability in Laboratory Medicine (JCTLM)- Its history and operation.Clin Chim Acta. 2016; 453: 86-94
- How to achieve harmonization of laboratory testing- the complete picture.Clin Chim Acta. 2014; 432: 8-14
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Footnotes
Conflict of Interest: D. Armbruster is an employee of Abbott Diagnostics.
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