메뉴 건너뛰기




Volumn 34, Issue 3, 2014, Pages 187-197

Harmonization: The sample, the measurement, and the report

Author keywords

Commutability; Harmonization; Standardization; Traceability

Indexed keywords

CLINICAL CHEMISTRY; DOCUMENTATION; LABORATORY; PRACTICE GUIDELINE; REFERENCE VALUE; STANDARDS;

EID: 84900437156     PISSN: 22343806     EISSN: 22343814     Source Type: Journal    
DOI: 10.3343/alm.2014.34.3.187     Document Type: Review
Times cited : (56)

References (47)
  • 2
    • 79957715132 scopus 로고    scopus 로고
    • Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus
    • Sacks DB, Arnold M, Bakris GL, Bruns DE, Horvath AR, Kirkman MS, et al. Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus. Clin Chem 2011;57:e1-e47.
    • (2011) Clin Chem , vol.57
    • Sacks, D.B.1    Arnold, M.2    Bakris, G.L.3    Bruns, D.E.4    Horvath, A.R.5    Kirkman, M.S.6
  • 4
    • 84882277889 scopus 로고    scopus 로고
    • Clinical and Laboratory Standards Institute CLSI document EP29-A. Wayne PA: Clinical and Laboratory Standards Institute
    • Clinical and Laboratory Standards Institute. Expression of measurement uncertainty in laboratory medicine; Approved Guideline. CLSI document EP29-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2012.
    • (2012) Expression of Measurement Uncertainty in Laboratory Medicine; Approved Guideline
  • 5
    • 74249116046 scopus 로고    scopus 로고
    • Basics of estimating measurement uncertainty
    • White GH. Basics of estimating measurement uncertainty. Clin Biochem Rev 2008;29(S1):S53-60.
    • (2008) Clin Biochem Rev , vol.29 , Issue.S1
    • White, G.H.1
  • 6
    • 66549112943 scopus 로고    scopus 로고
    • Traceability in laboratory medicine
    • Vesper HW and Thienpont LM. Traceability in laboratory medicine. Clin Chem 2009;55:1067-75.
    • (2009) Clin Chem , vol.55 , pp. 1067-1075
    • Vesper, H.W.1    Thienpont, L.M.2
  • 8
    • 0035210696 scopus 로고    scopus 로고
    • Protein standardization II: Dry mass determination procedure for the determination of the dry mass of a pure protein preparation
    • Blirup-Jensen S. Protein standardization II: dry mass determination procedure for the determination of the dry mass of a pure protein preparation. Clin Chem Lab Med 2001;39:1090-7.
    • (2001) Clin Chem Lab Med , vol.39 , pp. 1090-1097
    • Blirup-Jensen, S.1
  • 9
    • 78649819470 scopus 로고    scopus 로고
    • Characterization of the new serum protein reference material ERM-DA470k/IFCC: Value assignment by immunoassay
    • 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.
    • (2010) Clin Chem , vol.56 , pp. 1880-1888
    • Zegers, I.1    Keller, T.2    Schreiber, W.3    Sheldon, J.4    Albertini, R.5    Blirup-Jensen, S.6
  • 10
    • 80155171806 scopus 로고    scopus 로고
    • Variation in parathyroid hormone immunoassay results - A critical governance issue in the management of chronic kidney disease
    • Sturgeon CM, Sprague SM, Metcalfe W. Variation in parathyroid hormone immunoassay results-a critical governance issue in the management of chronic kidney disease. Nephrol Dial Transplant 2011;26:3440-5.
    • (2011) Nephrol Dial Transplant , vol.26 , pp. 3440-3445
    • Sturgeon, C.M.1    Sprague, S.M.2    Metcalfe, W.3
  • 13
    • 84877744505 scopus 로고    scopus 로고
    • Harmonization of immunoassays to the all-procedure trimmed mean-proof of concept by use of data from the insulin standardization project
    • Van Houcke SK, Van Aelst S, Van Uytfanghe K, Thienpont LM. Harmonization of immunoassays to the all-procedure trimmed mean-proof of concept by use of data from the insulin standardization project. Clin Chem Lab Med 2013;51:e103-5.
    • (2013) Clin Chem Lab Med , vol.51
    • Van Houcke, S.K.1    Van Aelst, S.2    Van Uytfanghe, K.3    Thienpont, L.M.4
  • 16
    • 84883376073 scopus 로고    scopus 로고
    • Commutability still matters
    • Miller WG and Myers GL. Commutability still matters. Clin Chem 2013;59:1291-3.
    • (2013) Clin Chem , vol.59 , pp. 1291-1293
    • Miller, W.G.1    Myers, G.L.2
  • 18
    • 0015544175 scopus 로고
    • A discussion of enzyme reference materials: Applications and specifications
    • Fasce CF Jr, Rej R, Copeland WH, Vanderlinde RE. A discussion of enzyme reference materials: applications and specifications. Clin Chem 1973;19:5-9.
    • (1973) Clin Chem , vol.19 , pp. 5-9
    • Fasce Jr., C.F.1    Rej, R.2    Copeland, W.H.3    Vanderlinde, R.E.4
  • 20
    • 0031800740 scopus 로고    scopus 로고
    • Characterization of cardiac troponin subunit release into serum after acute myocardial infarction and comparison of assays for troponin T and i
    • Wu AH, Feng YJ, Moore R, Apple FS, McPherson PH, Buechler KF, et al. Characterization of cardiac troponin subunit release into serum after acute myocardial infarction and comparison of assays for troponin T and I. Clin Chem 1998;44:1198-208.
    • (1998) Clin Chem , vol.44 , pp. 1198-1208
    • Wu, A.H.1    Feng, Y.J.2    Moore, R.3    Apple, F.S.4    McPherson, P.H.5    Buechler, K.F.6
  • 21
    • 84882258874 scopus 로고    scopus 로고
    • Progress toward standardization: An ifcc scientific division perspective
    • Gillery P and Young IS. Progress toward standardization: an IFCC Scientific Division Perspective. Clin Chem Lab Med 2013;51:915-8.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 915-918
    • Gillery, P.1    Young, I.S.2
  • 22
    • 85169769644 scopus 로고    scopus 로고
    • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. (Dec 7);L331: 1-37
    • Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices. Official Journal of the European Communities 1998(Dec 7);L331:1-37.
    • (1998) Official Journal of the European Communities
  • 27
    • 51749083776 scopus 로고    scopus 로고
    • Case detection, diagnosis, and treatment of patients with primary aldosteronism: An endocrine society clinical practice guideline
    • Funder JW, Carey RM, Fardella C, Gomez-Sanchez CE, Mantero F, Stowasser M, et al. Case detection, diagnosis, and treatment of patients with primary aldosteronism: an endocrine society clinical practice guideline. J Clin Endocrinol Metab 2008;93:3266-81.
    • (2008) J Clin Endocrinol Metab , vol.93 , pp. 3266-3281
    • Funder, J.W.1    Carey, R.M.2    Fardella, C.3    Gomez-Sanchez, C.E.4    Mantero, F.5    Stowasser, M.6
  • 28
    • 84891544363 scopus 로고    scopus 로고
    • Glycemic control in the 12 months following a change to SI hemoglobin A1c reporting units
    • Kilpatrick ES, Rigby AS, Atkin SL, Barth JH. Glycemic control in the 12 months following a change to SI hemoglobin A1c reporting units. Clin Chem 2013;59:1457-60.
    • (2013) Clin Chem , vol.59 , pp. 1457-1460
    • Kilpatrick, E.S.1    Rigby, A.S.2    Atkin, S.L.3    Barth, J.H.4
  • 29
    • 84900407443 scopus 로고    scopus 로고
    • The UCUM Organization (Updated on Oct 2013)
    • The UCUM Organization, The Unified Code for Units of Measure. http://unitsofmeasure.org (Updated on Oct 2013).
    • The Unified Code for Units of Measure
  • 30
    • 85169775906 scopus 로고    scopus 로고
    • Accessed on Jan 2014
    • Pathology Harmony, UK. http://www.pathologyharmony.co.uk (Accessed on Jan 2014).
    • Pathology Harmony UK
  • 31
    • 85169774390 scopus 로고    scopus 로고
    • Royal College of Pathologists of Australasia Updated on Nov 2013
    • Royal College of Pathologists of Australasia, Pathology terminology and information standardization downloads. http://www.rcpa.edu.au/Library/ Practising-Pathology/PTIS/APUTS-Downloads (Updated on Nov 2013).
    • Pathology Terminology and Information Standardization Downloads
  • 33
    • 84882259359 scopus 로고    scopus 로고
    • Harmonization in laboratory medicine: The complete picture
    • Plebani M. Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med 2013;51:741-51.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 741-751
    • Plebani, M.1
  • 35
    • 84882992273 scopus 로고    scopus 로고
    • Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?-A pilot study and a proposal
    • Jassam N, Yundt-Pacheco J, Jansen R, Thomas A, Barth JH. Can current analytical quality performance of UK clinical laboratories support evidence-based guidelines for diabetes and ischaemic heart disease?-A pilot study and a proposal. Clin Chem Lab Med 2013;51:1579-84.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 1579-1584
    • Jassam, N.1    Yundt-Pacheco, J.2    Jansen, R.3    Thomas, A.4    Barth, J.H.5
  • 36
    • 82055183863 scopus 로고    scopus 로고
    • Laboratory reporting of urine protein and albumin
    • Jones GR. Laboratory reporting of urine protein and albumin. Clin Biochem Rev 2011;32:103-7.
    • (2011) Clin Biochem Rev , vol.32 , pp. 103-107
    • Jones, G.R.1
  • 37
    • 84872397848 scopus 로고    scopus 로고
    • Application of the Stockholm hierarchy to defining the quality of reference intervals and clinical decision limits
    • Sikaris K. Application of the Stockholm hierarchy to defining the quality of reference intervals and clinical decision limits. Clin Biochem Rev 2012;33:141-8.
    • (2012) Clin Biochem Rev , vol.33 , pp. 141-148
    • Sikaris, K.1
  • 38
    • 3142704433 scopus 로고    scopus 로고
    • The nordic reference interval project 2000: Recommended reference intervals for 25 common biochemical properties
    • Rustad P, Felding P, Franzson L, Kairisto V, Lahti A, Mårtensson A, et al. The Nordic Reference Interval Project 2000: recommended reference intervals for 25 common biochemical properties. Scand J Clin Lab Invest 2004;64:271-84.
    • (2004) Scand J Clin Lab Invest , vol.64 , pp. 271-284
    • Rustad, P.1    Felding, P.2    Franzson, L.3    Kairisto, V.4    Lahti, A.5    Mårtensson, A.6
  • 39
    • 84882276801 scopus 로고    scopus 로고
    • Committee on reference intervals and decision limits (c-ridl), international federation for clinical chemistry and laboratory medicine. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values
    • Ozarda Y, Ichihara K, Barth JH, Klee G; Committee on Reference Intervals and Decision Limits (C-RIDL), International Federation for Clinical Chemistry and Laboratory Medicine. Protocol and standard operating procedures for common use in a worldwide multicenter study on reference values. Clin Chem Lab Med 2013;51:1027-40.
    • (2013) Clin Chem Lab Med , vol.51 , pp. 1027-1040
    • Ozarda, Y.1    Ichihara, K.2    Barth, J.H.3    Klee, G.4
  • 40
    • 79956098908 scopus 로고    scopus 로고
    • Pathology Harmony; A pragmatic and scientific approach to unfounded variation in the clinical laboratory
    • Berg J and Lane V. Pathology Harmony; a pragmatic and scientific approach to unfounded variation in the clinical laboratory. Ann Clin Biochem 2011;48:195-7.
    • (2011) Ann Clin Biochem , vol.48 , pp. 195-197
    • Berg, J.1    Lane, V.2
  • 41
    • 85169768136 scopus 로고    scopus 로고
    • Australasian Association of Clinical Biochemists (Accessed on Jan 2014)
    • Australasian Association of Clinical Biochemists, Australasian Association of Clinical Biochemists Harmonisation Activity. www.aacb.asn.au/ professionaldevelopment/harmonisation (Accessed on Jan 2014).
    • Australasian Association of Clinical Biochemists Harmonisation Activity
  • 42
    • 84900453846 scopus 로고    scopus 로고
    • On behalf of the AACB committee for common reference intervals. Evidence-based approach to harmonized reference intervals
    • doi: 10.1016/j.cca.2013.10.021.[Epub ahead of print]
    • Koerbin G, Sikaris KA, Jones GR, Ryan J, Reed M, Tate J; On behalf of the AACB Committee for Common Reference Intervals. Evidence-based approach to harmonized reference intervals. Clin Chim Acta 2013; doi: 10.1016/j.cca.2013.10. 021.[Epub ahead of print].
    • (2013) Clin Chim Acta
    • Koerbin, G.1    Sikaris, K.A.2    Jones, G.R.3    Ryan, J.4    Reed, M.5    Tate, J.6
  • 44
    • 84872420981 scopus 로고    scopus 로고
    • Allowable limits of performance' for external quality assurance programs-an approach to application of the stockholm criteria by the rcpa quality assurance programs
    • Jones GR, Sikaris K, Gill J. 'Allowable Limits of Performance' for External Quality Assurance Programs-an Approach to Application of the Stockholm Criteria by the RCPA Quality Assurance Programs. Clin Biochem Rev 2012;33:133-9.
    • (2012) Clin Biochem Rev , vol.33 , pp. 133-139
    • Jones, G.R.1    Sikaris, K.2    Gill, J.3
  • 46
    • 84901603058 scopus 로고    scopus 로고
    • Validating common reference intervals in routine laboratories
    • doi: 10.1016/j.cca.2013.10.005. [ Epub ahead of print]
    • Jones GR. Validating common reference intervals in routine laboratories. Clin Chim Acta 2013; doi: 10.1016/j.cca.2013.10.005. [Epub ahead of print].
    • (2013) Clin Chim Acta
    • Jones, G.R.1
  • 47
    • 84867797654 scopus 로고    scopus 로고
    • Obtaining reference intervals traceable to reference measurement systems: Is it possible who is responsible what is the strategy?
    • Panteghini M and Ceriotti F. Obtaining reference intervals traceable to reference measurement systems: is it possible, who is responsible, what is the strategy? Clin Chem Lab Med 2011;50:813-7.
    • (2011) Clin Chem Lab Med , vol.50 , pp. 813-817
    • Panteghini, M.1    Ceriotti, F.2


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.