Publications

This section contains ‘living file’ of the more important publications related to traceability in laboratory medicine and its impact on reducing between-method variability and improving clinical outcomes for patients.  The publications are presented in four categories. Where possible a hyperlink is provided to the original publication

Requests to have publications added to this section should be directed to the JCTLM Secretariat jctlm@bipm.org

 

Publications from the scientific and clinical literature:

Review articles:

  • Traceability in laboratory medicine: a global driver for accurate results in patient care.  Beastall GH, Brouwer N, Quiroga S, Myers GL. Clin Chem Lab Med 2017; 55(8): 1100-1108. https://doi.org/10.1515/cclm-2017-0060
  • Harmonization: its time has come. Miller WG. Clin Chem 2017; 63: 1184-1186 Download the document
  • Time for a holistic approach and standardization education in laboratory medicine. Cobbaert C. Clin Chem Lab Med 2017. Download the document.
  • Metrological Traceability Comparability of Test Results. Clin Lab Med 2017 Armbruster. Download the document.
  • Harmonization of clinical test results. Tate JR, Myers GL. eJIFCC 2016; 27: 1-10. Download the document.
  • Harmonization of clinical laboratory test results: the role of the IVD industry. Armbruster D, Donnelly J. eJIFCC 2016; 27: 37-47. Download the document.
  • Harmonization of laboratory testing – Current achievements and future strategies. Tate JR, Johnson R, Barth J, Panteghini M. Clin Chim Acta 2014; 432: 4-7
  • Update on current concepts and meanings in laboratory medicine – standardization, traceability and harmonization. Greenberg N. Clin Chim Acta 2014; 432: 49-54
  • Metrological traceability – a concept for standardization in laboratory medicine. Siekmann L. Clin Chem Lab Med 2013; 51: 953-958
  • Progress towards standardization: an IFCC Scientific Division perspective. Gillery P, Young IS. Clin Chem Lab Med. 2013; 51:915-8
  • Harmonization in laboratory medicine: the complete picture. Plebani M. Clin Chem Lab Med 2013; 51:741-51.
  • Uncertainty in measurement and total error: tools for coping with diagnostic uncertainty. Theodorsson E. Clin Lab Med 2017; 37: 15-34. Download the document
  • Metrological traceability in clinical biochemistry. White GH. Ann Clin Biochem 2011; 48: 393-409
  • Traceability as a unique tool to improve standardization in laboratory medicine. Panteghini M. Clin Biochem 2009; 42:236-40
  • Traceability in Laboratory Medicine. Vesper HW, Thienpont LM. Clin Chem 2009; 55:1067-75
  • Traceability, reference systems and result comparability. Panteghini M. Clin Biochem Rev 2007; 28: 97-104

Articles on scientific concepts related to traceability: 

  • Analytical performance specifications for external quality assessment: - definitions and descriptions. Jones GRD, Albarede S, Kesseler D, MacKenzie F, Mammen J, Pedersen M et al. Clin Chem Lab Med 2017; 55(7): 949-955
  • The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) – a pathway for harmonization. Myers GL, Miller WG. eJIFCC 2016;27:30-36
  • Harmonization of test results:what are the challenges; how can we make it better? Miller WG, Eckfeldt JH, Passarelli J, Young IS. Clin Chem 2014; 60: 923-27
  • Roadmap for harmonization of clinical laboratory measurement procedures. Miller WG, Myers GL, Gantzer ML, et al. Clin Chem 2011; 57:1108-17 
  • Commutability still matters. Miller WG, Myers GL. Clin Chem 2013; 59: 1291-93
  • Why commutability matters. Miller WG, Myers GL, Rej R. Clin Chem 2006; 52: 553-54 
  • Measurement uncertainty – a revised understanding of its calculation and use. Tate JR, Plebani M. Clin Chem Lab Med 2016; 54: 1277-80
  • Measurement uncertainty for clinical laboratories – a revision of the concept. Jones GRD. Clin Chem Lab Med 2016; 54: 1303-08
  • Uncertainty in measurement and total error – are they so incompatible? Farrance I, Badrick T, Sikaris KA. Clin Chem Lab Med 2016; 54: 1309-12 
  • The IFCC external quality assessment scheme for reference laboratories – review of 8 years’ experience. Kessler A, Siekmann L, Weykamp C , Geilenkeuser WJ , Dreazen O, Jonathan Middle J, Schumann G. Clin Chem Lab Med. 2013;51: 997-1005
  • Requirements for reference (calibration) laboratories in laboratory medicine. Siekmann L. Clin Biochem Rev 2007; 28: 149-54 
  • Defining acceptable limits for the metrological traceability of specific measurands. Bais R , Armbruster D , Jansen RTP, Klee G, Panteghini M, Passarelli J, Sikaris KA. Clin Chem Lab Med. 2013; 51: 973-79.

 Articles related to specific methods or tests:

 Amyloid-β

  • CSF Aβ1-42 - an excellent but complicated Alzheimer's biomarker - a route to standardisation. Kuhlmann J, Andreasson U, Pannee J, Bjerke M, Portelius E, Leinenbach A, Bittner T, Korecka M, Jenkins RG, Vanderstichele H, Stoops E, Lewczuk P, Shaw LM, Zegers I, Schimmel H, Zetterberg H, Blennow K. Clin Chim Acta. 2016 May 20. pii: S0009-8981(16)30218-2. doi: 10.1016/j.cca.2016.05.014. [Epub ahead of print]
    PMID: 27216941
  • Mass spectrometry-based candidate reference measurement procedure for quantification of Amyloid-β in cerebrospinal fluid. Leinenbach A; Pannee J; Dülffer T; Huber A; Bittner T; Andreasson U; Gobom J; Zetterberg H; Kobold U; Portelius E; Blennow K. Clin Chem. 2014;60: 987-94

Autoimmune testing

  • Development of a certified reference material for myeloperoxidase-anti-neutrophil cytoplasmic autoantibodies (MPO-ANCA). Monogioudi E, Hutu DP, Martos G, Sheldon J, Schimmel H, Meroni PL, Zegers I. Clin Chim Acta. 2016 Jun 1. pii: S0009-8981(16)30243-1. doi: 10.1016/j.cca.2016.05.031. [Epub ahead of print]
    PMID: 27262820 [PubMed - as supplied by publisher]
  • First steps in the standardisation of IgG MPO-ANCA measurement. Hutu DP, Tuddenham E, Monogioudi E, Meroni P, Schimmel H, Sheldon J, Zegers I. Clin Exp Immunol. 2016; 183: 193-205

Bone markers

  • Markers of bone turnover for the prediction of fracture risk and monitoring of osteoporosis treatment: a need for international reference standards. Vasikaran S, Eastell R, Bruyere O, Foldes AJ, Garnero P, Griesmacher A, McClung M, Morris HA, Silverman S, Trenti T, et al. Osteoporosis International 2010; 22: 391-420

Carbohydrate deficient transferrin

  • Standardisation and use of the alcohol biomarker carbohydrate-deficient transferrin (CDT). Helander A, Wielders J, Anton R, Arndt T, Bianchi V, Deenmamode J, Jeppsson JO, Whitfield JB, Weykamp C, Schellenberg F. Clin Chim Acta. 2016;459: 19-24
  • Harmonization of measurement results of the alcohol biomarker carbohydrate-deficient transferrin by use of the toolbox of technical procedures of the International Consortium for Harmonization of Clinical Laboratory Results. Weykamp C; Wielders J; Helander A; Anton RF; Bianchi V; Jeppsson JO; Siebelder C; Whitfield JB; Schellenberg F. Clinical Chemistry 2014; 60: 945-53
  • Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: III. Performance of native serum and serum spiked with disialotransferrin proves that harmonization of CDT assays is possible. Weykamp C, Wielders JP, Helander A, Anton RF, Bianchi V, Jeppsson JO, Siebelder C, Whitfield JB, Schellenberg F. Clin Chem Lab Med. 2012:1-6;  Clin Chem Lab Med. 2013;51:991-96
  • Toward standardization of carbohydrate-deficient transferrin (CDT) measurements: II. Performance of a laboratory network running the HPLC candidate reference measurement procedure and evaluation of a candidate reference material. Helander A, Wielders JPM, Jeppsson JO, Weykamp C, Siebelder C, Anton RF, Schellenberg F, Whitfield JB. Clin Chem Lab Med, 2010; 48: 1585-92
  • Towards Standardization of Carbohydrate-deficient Transferrin (CDT) Measurements: I.Analyte Definition and Proposal of a candidate Reference Method. Jeppsson J-O, Arndt T, Schellenberger F, Wielders JPM, Anton RF, Whitfield JB, Helander A. Clin Chem Lab Med 2007;45:558–62.

Cardiac biomarkers

  • Evaluation of standardization capability of current cardiac troponin I assays by a correlation study: results of an IFCC pilot project. Tate JR, Bunk DM, Christenson RH, Barth JH, Katrukha A, Noble JE, Schimmel H, Wang L, Panteghini M. Clin Chem Lab Med. 2015;53: 677-90
  • Point/Counterpoint article on the standardization of cTnI measurement. Christenson RC, Bunk DM, Schimmel H, Tate JR. Clinical Chemistry 2012; 58: 165-68
  • Standardization of Cardiac Troponin I Measurement: Past and Present. Tate JR, Bunk DM, Christenson RH, Katrukha A, Noble JE, Porter RA, Schimmel H, Wang L Panteghini M. Pathology 2010; 45: 402-08
  • Development of a candidate secondary reference procedure (immunoassay based measurement procedure of higher metrological order) for cardiac troponin I: I. Antibody characterization and preliminary validation. Noble JE, Bunk DM, Christenson RH, Cole KD, He HJ, Katrukha AG, Panteghini M, Porter RA, Schimmel H, Tate JR, Wang L. Clin Chem Lab Med, 2010; 48: 1603-10
  • Standardization of troponin I measurements: an update. Panteghini M, Bunk DB, Christenson RH, Katrukha A, Porter RA, Schimmel H, Wang L, Tate JR. Clin Chem Lab Med 2008; 46: 1501-6
  • Analytical issues for biomarkers of heart failure. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine practice guidelines. Analytical issues for biomarkers of heart failure. Apple FS, Wu AHB, Jaffe AS, Panteghini M, Christenson RH. Circulation Clin Biochem 2008; 41: 222-226
  • Analytical issues for biochemical markers of acute coronary syndromes. National Academy of Clinical Biochemistry and IFCC Committee for Standardization of Markers of Cardiac Damage Laboratory Medicine Practice Guidelines. Analytical Issues for biochemical markers of acute coronary syndromes. Apple FS, Jesse RL, Newbt LK, Wu AH, Christensen RH, Cannon CP, Francis G, Morrow DA, Ravkilde J, Storrow AB, Tang W, Jaffe AS, Mair J, Orsonez-Llanos J, Pagani F, Panteghini M, Tate J. Clin Chem 2007; 53: 547-51;

Cholesterol

  • A cost-benefit analysis of lipid standardization in the United States. Hoerger TJ, Wittenborn JS, Young W. Prev Chron Dis 2011; 8: A136
  • Explaining the decrease in US deaths from coronary disease 1980-2000. Ford ES, Ajani UA, Croft JB et al. NEJM 2007; 356: 2388-98
  • A reference laboratory network for cholesterol: a model for standardization and improvement of clinical laboratory. Myers GL, Kimberly MM, Waymack PP, Smith SJ, Cooper GR, Sampson EJ Clin Chem 2000; 46: 1762-72
  • The CDC –National Heart, Lung and Blood Institute Lipid Standardization Program: An approach to accurate and precise lipid measurements. Myers GL, Cooper GR, Winn CL, Smith SJ Clin Lab Med 1989; 9: 105-35

Creatinine

  • Specificity characteristics of 7 commercial creatinine measurement procedures by enzymatic and Jaffe method principles. Greenberg N, Roberts WL, Bachmann LM, Wright EC, Dalton RN, Zakowski JJ, Miller WG. Clinical Chemistry 2012; 58: 391-401
  • Recommendations for Improving Serum Creatinine Measurement: A Report from the Laboratory Working Group of the National Kidney Disease Education Program. Myers GL, Miller WG, Coresh J, Fleming J, Greebergs N, Greene T, Hostetter T, Levey AS, Panteghini M, Welch, Eckfeldt J. Clin Chem 2006; 52: 5-18
  • The importance of metrological traceability on the validity of creatinine measurement as an index of renal function. Panteghini M, Myers GL, Miller GW, Greenberg N. Clin Chem Lab Med 2006; 44: 1187–92
  • National Kidney Disease Education Program Laboratory Working Group: recommendations for improving serum creatinine measurement: a report from the Laboratory Working Group of the National Kidney Disease Education Program. Myers GL, Miller WG, Coresh J, Fleming J, Greenberg N, Greene T, Hostetter T, Levey AS, Panteghini M, Welch M, Eckfeldt JH. Clin Chem 2006; 52: 5-18
  • Creatinine measurement: state of the art in accuracy and interlaboratory harmonization. Miller WG, Myers GL, Ashwood ER, Killeen AA, Wang E, Thienpont LM, Siekmann L Arch Pathol Lab Med 2005; 129:297-303

Cystatin C

  • The first harmonization step on cystatin C, with the aim to introduce the first ERM-DA471/IFCC cystatin C calibrator and one worldwide company-independent EGFR equation. Hansson L, Flodin M, Larsson A, et al. Clin Chem Lab Med. 2011
  • First Certified Reference Material for Cystatin C in human serum ERM-DA471/IFCC. Grubb A, Blirup-Jensen S, Lindstrom V, Schmidt C, Althaus H, Zegers I. Clin Chem Lab Med, 2010; 48: 1619-21
  • Standardization of cystatin C: Development of primary and secondary reference preparations. Blirup-Jensen S, Grubb A, Lindström V, Schmidt C, Althaus H.  Scand J Clin Lab Invest 2008; 68. Suppl. 241: 67-70.

Enzymes

  • IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 8C. Part 9: Reference procedure for the measurement of catalytic concentration of alkaline phosphatase. Schumann G., Klauke R., Canalias F., Bossert-Reuther S., Franck P.F.H, Gella F.J., Jørgensen P.J.,Dongchon Kang7, Lessinger J.M., Panteghini M., Ceriotti F. Clin Chem Lab Med 2011;49:1439-46
  • Standardization in clinical enzymology: a challenge for the theory of metrological traceability. Infusino I, Schumann G, Ceriotti F, Panteghini M. Clin Chem Lab Med. 2010; 48: 301-07
  • Traceability of values for catalytic activity concentration of enzymes: a certified reference material for aspartate transaminase. Toussaint B, Emons H, Schimmel HG, Bossert-Reuther S, Canalias F, Ceriotte F, Férard G, Ferrero CA, Franck PFH, Gella FJ, Henry J, Jorgensen PJ, Klauke R, Lessinger JM, Mazziotta D, Panteghini M, Ueda S, Schumann G. Clin Chem Lab Med 2010; 48: 795-803
  • 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. Jansen R, Schumann G, Baadenhuijsen H, Frank P, Franzini C, Kruse R, Kuypers A, Weykamp C, Panteghini M. Clin Chim Acta 2006; 368: 160-67
  • IFCC primary reference procedures for the measurement of catalytic activity concentrations of enzymes at 37 degrees C: Part 8. Reference procedure for the measurement of catalytic concentration of alpha-amylase [alpha-Amylase: 1,4-alpha-D-glucan 4-glucanohydrolase (AMY), EC 3.2.1.1]. Schumann G, Aoki R, Ferrero CA, Ehlers G, Férard G, Gella FJ, Jorgensen PJ, Kanno T, Kessner A, Klauke R, Kytzia HJ, Lessinger JM, Miller WG, Nagel R, Pauwels J, Schimmel H, Siekmann L, Weidemann G, Yoshida K, Ceriotti F. Clin Chem Lab Med 2006; 44: 1146-55.

Growth hormone

  • Harmonizing growth hormone measurements: learning lessons for the future. Wieringa G, Trainer PJ. J Clin Endocrinol Metabol 2007;92: 2874-75
  • Variation in GH and IGF-I assays limits the applicability of international consensus criteria to local practice. Pokrajac A, Wark G, Ellis AR, Wear J, Wieringa GE, Trainer PJ. Clinical Endocrinology 2007; 67: 65-70.
  • Growth hormone assay standardization: an important clinical advance. Sheppard MC. Clin Endocrinol 2007; 66: 157-61
  • Consensus statement on the standardisation of GH assays. Trainer PJ, Barth J, Sturgeon C, Wieringa G. Eur J Endocrinol 2006;155:1-2

Haemoglobin A1c

  • Investigation of 2 models to set and evaluate quality targets for hb a1c: biological variation and sigma-metrics. Weykamp C, John G, Gillery P, English E, Ji L, Lenters-Westra E, Little RR, Roglic G, Sacks DB, Takei I. Clin Chem 2015;61:752-9
  • 2013 Update on the worldwide standardization of the hemoglobin A1c measurement. Hanas R, John G. Clin Chem Lab Med 2013; 51: 1041–1042
  • 2010 Consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Hanas R, John G. Clin Chem Lab Med, 2010; 48: 775-6
  • The IFCC Reference Measurement System for HbA1c: A 6-Year Progress Report. Weykamp C, John WG,  Mosca A, Hoshino T, Little R, Jeppsson J-O,  Goodall I, Miedema K, Myers G, Reinauer H,  Sacks DB, Slingerland R, Siebelder C. Clin Chem 2008; 54: 240-8
  • HbA1c Standardisation: History, Science and Politics. John WG, Mosca A, Weykamp C, Goodall I. Clin Biochem Rev 2007; 28: 163-8
  • Global standardization of glycated hemoglobin measurement: the position of the IFCC Working Group. Mosca IF, Goodhall I, Hoshino T, Jeppson JO, John WG, Little RR, Miedema K, Myers GL, Reinauer H, Sacks DB, Weycamp C. Clin Chem Lab Med 2007; 45: 1077-80
  • Implementation of Haemoglobin A1c results traceable to the IFCC reference system: the way forward. Panteghini M, John WG. Clin Chem Lab Med 2007; 45: 942-4
  • Consensus statement on the worldwide standardization of the hemoglobin A1c measurement. Hicks JMB, Müller MM, Panteghini M, John WG, Deeb L, Buse J, Nathan DM, Kahn R, Ferrannini E, Heine R, Mbanya JC. Diabetes Care 2007; 30: 2399-400
  • Recommendation for term and measurement unit for “HbA1c”. Nordin G, Dybkaer R. Clin Chem Lab Med 2007; 45: 1081-82
  • Uncertainty calculation for calibrators of the IFCC HbA1c standardisation network. Konnert A, Arends S, Schubert S, Berding C, Weykamp C, Siebelder C. Accred Qual Assur 2006; 11: 319-328
  • IFCC Reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan and Sweden: a method comparison study. Hoelzel W, Weycamp C, Jeppsson JO et al. Clin Chem 2004; 50: 166-74 

Haemoglobin A2

  • Developing a reference system for the IFCC standardization of HbA2. Paleari R, Caruso D, Kaiser P, Arsene CG, Schaeffer-Reiss C, Van Dorsselaer A, Bissé E, Ospina M, De Jesús VR, Wild B, Mosca A; Clin Chim Acta. 2016 May 27. pii: S0009-8981(16)30235-2. doi: 10.1016/j.cca.2016.05.023. [Epub ahead of print]
  • Analytical goals for the determination of HbA2. Mosca A , Paleari R, Wild B. Clin Chem Lab Med 2013; 51: 937-41
  • Towards the Development of a Certified Reference Material for Haemoglobin A2. Paleari R, Munoz A, Mosca A. Clin Chem Lab Med, 2010; 48: 1611-18

Human chorionic gonadotrophin

  • Clinical assays for human chorionic gonadotropin: what should we measure and how? Gronowski AM. Clin Chem 2009; 55:1900-04.
  • Differences in Recognition of the 1st WHO International Reference Reagents for hCG-Related Isoforms by Diagnostic Immunoassays for Human Chorionic Gonadotropin. Sturgeon CM, Berger P, Bidart JM, Birken S, Burns C, Norman RJ, Stenman UH. Clinical Chemistry 2009; 55: 1484-91
  • Characterization of the hCG Variants Recognized by Different hCG Immunoassays: An Important Step Toward Standardization of hCG Measurements. Gronowski AM, Grenache DG. Clin Chem 2009; 55: 1447-49
  • Establishment, value assignment, and characterization of new who reference reagents for six molecular forms of human chorionic gonadotropin. Bristow A, Berger P, Bidart J-M, Birken S, Norman R, Stenman U-H, Sturgeon C, on behalf of the IFCC Working Group on human chorionic gonadotropin.Clin Chem 2005; 51: 177–82.
  • Preparation and characterization of new WHO reference reagents for human chorionic gonadotropin and metabolites. Birken S, Berger P, Bidart JM, Weber M, Bristow A, Norman R, et al.Clin Chem 2003; 49: 144-54

Insulin and insulin C-peptide

  • Human C-peptide quantitation by LC-MS isotope-dilution assay in serum or urine samples. Stoyanov AV, Connolly S, Rohlfing CL, Rogatsky E, Stein D, Little RR. J Chromatog Separation Techniq 2013; 4: 3
  • Development of SI-traceable C-peptide certified reference material NMIJ CRM 6901-a using isotope dilution mass spectrometry-based amino acid analyses. Kinumi T, el al, Anal Bioanal Chem 2012; 404: 13-21
  • Insulin assay standardization leading to measures of insulin sensitivity and secretion for practical clinical care. Staten MA, Stern MP, Miller WG, Steffes MW, Campbell SE. Diabetes Care 2010; 33: 205-06
  • Toward standardization of insulin immunoassays. Miller WG, Thienpont LM,Van Uytfanghe K, Clark PM, Lindstedt P. Clinical Chemistry 2009; 55: 1011-8
  • Standardization of C-peptide measurements. Little RR, Rohlfing CL, Tennill AL, Madsen RW, Polonsky KS, Myers GL, Greenbaum CJ, Palmer JP, Rogatsky E, Stein DT. Clin Chem 2008; 54: 1023-26
  • Standardization of Insulin Immunoassays: Report of the American Diabetes Association Workgroup. Marcovina S, Bowser RR, Miller WG, Staten M, Myers G, Caudill SP, Campbell SE, Steffes MW. Clinical Chemistry 2007; 53; 711-16

Thyroid function tests

  • Harmonization of serum thyroid stimulating hormone measurements paves the way for the adoption of a more uniform reference internal. Thienpont LM, Van Uytfanghe K, De Grande LA, Reynders D, Das B, Faix JD, et al. Clin Chem 2017; 63: 1248-1260
  • Standardization of FT4 and harmonization of TSH measurements--a request for input from endocrinologists and other physicians. Thienpont LM, Faix JD, Beastall G. Endocr Pract. 2016; 22:374
  • Monitoring the stability of the standardization status of FT4 and TSH assays by use of daily outpatient medians and flagging frequencies. De Grande LA, Goossens K, Van Uytfanghe K, Das B, MacKenzie F, Patru MM, Thienpont LM. Clin Chim Acta. 2016 Apr 27. pii: S0009-8981(16)30157-7. doi: 10.1016/j.cca.2016.04.032
  • A Progress Report of the IFCC Committee for Standardization of Thyroid Function Tests. Thienpont LM, Van Uytfanghe K, Van Houcke S, Das B, Faix JD, MacKenzie F, Quinn FA, Rottmann M, Van den Bruel A. Eur Thyroid J. 2014 Jun;3(2):109-16
  • IFCC international conventional reference procedure for the measurement of free thyroxine in serum. Van Houcke SK, Van Uytfanghe K, Shimizu E, Tani W, Umemoto M, Thienpont LM. Clin Chem Lab Med. 2011; 49: 1275-81
  • Standardization activities in the field of thyroid function tests: a status report. Thienport LM, van Uytfanghe K, van Houcke S. Clin Chem Lab Med, 2010; 48: 1611-18
  • Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 3: total thyroxine and total triiodothyronine. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, Nelson JC, Ronin C, Ross HA, Thijssen JH, Toussaint B; IFCC Working Group on Standardization of Thyroid Function Tests. Clin Chem. 2010; 56: 921-29
  • Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 2: free thyroxine and free triiodothyronine. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, Nelson JC, Ronin C, Ross HA, Thijssen JH, Toussaint B; IFCC Working Group on Standardization of Thyroid Function Tests. Clin Chem. 2010; 56: 912-20
  • Report of the IFCC Working Group for Standardization of Thyroid Function Tests; part 1: thyroid-stimulating hormone. Thienpont LM, Van Uytfanghe K, Beastall G, Faix JD, Ieiri T, Miller WG, Nelson JC, Ronin C, Ross HA, Thijssen JH, Toussaint B; IFCC Working Group on Standardization of Thyroid Function Tests. Clin Chem. 2010; 56: 902-11.
  • Proposal of a candidate international conventional reference measurement procedure for free thyroxine in serum. Thienpont IF, Beastall G, Christophides ND, Faix JD, Ieiri T, Jarrige V, Miller WG, Miller R, Nelson JC, Ronin C, Ross HA, Rottman M, Thijssen JH, Toussaint B. Clin Chem Lab Med 2007; 45: 934-36

Urine albumin

  • A reference system for urinary albumin: current status. Lieske JC, Bondar O, Miller WG, Bachmann LM, Narva AS, Itoh Y, Zegers I, Schimmel H, Phinney K, Bunk DM. Clin Chem Lab Med. 2013; 51:981-89
  • Current Issues in Measurement and Reporting of Urinary Albumin Excretion. Miller WG, Bruns DE, Hortin GL, Sandberg S, Aakre KM, McQueen MJ, Itoh Y, Lieske JC, Seccombe DE, Jones G, Bunk DM, Curhan GC, Narva AS. Clin Chem 2009; 55: 24–38
  • Laboratory issues in measuring and reporting urine albumin. Miller WG, Bruns DE. Nephrol Dial Transplant 2009; 24: 717-18
  • Urine albumin: recommendations for standardization. Miller WG. Scand J Clin Lab Invest 2008; 68 (Suppl. 241): 71-72 

Relevant ISO documents: 

  • ISO 17511: 2003. In vitro diagnostic medical devices - measurement of quantities in biological samples – metrological traceability of values assigned to calibrators and control materials. ISO, Geneva, Switzerland; 2003 (under revision)
  • ISO 15193: 2009. In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for content and presentation of reference measurement procedures. ISO, Geneva, Switzerland; 2009
  • ISO 15194:2009. In vitro diagnostic medical devices -- Measurement of quantities in samples of biological origin -- Requirements for certified reference materials and the content of supporting documentation. ISO, Geneva, Switzerland; 2009
  • ISO 15195:2003. Laboratory medicine -- Requirements for reference measurement laboratories. ISO, Geneva, Switzerland; 2003 (under revision)
  • ISO 15189:2012. Medical laboratories -- Requirements for quality and competence. ISO, Geneva, Switzerland; 2012 

 

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