Harmonization
Myers GL, Miller WG. The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) – a pathway for harmonization. eJIFCC 2016;27:30-36 https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC4975215&blobtype=pdf
Miller WG, Eckfeldt JH, Passarelli J, Young IS. Harmonization of test results: what are the challenges; how can we make it better? Clin Chem 2014; 60: 923-927 https://doi.org/10.1373/clinchem.2012.201186
Miller WG, Myers GL, Gantzer ML, et al. Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem 2011; 57:1108-1117 https://doi.org/10.1373/clinchem.2011.164012
Aarsand, A. K., Roraas, T., Bartlett, W. A., Coskun, A., Carobene, A., Fernandez-Calle, P., Jonker, N., Diaz-Garzon, J., Braga, F., Sandberg, S., & Chem, E. F. C. (2018). Harmonization initiatives in the generation, reporting and application of biological variation data. Clinical Chemistry and Laboratory Medicine, 56(10), 1629-1636. https://doi.org/10.1515/cclm-2018-0058
Armbruster, D., & Donnelly, J. (2016). Harmonization of Clinical Laboratory Test Results: The Role of the IVD Industry. eJIFCC, 27(1), 37-47. https://www.ncbi.nlm.nih.gov/pubmed/27683505
Arnaud, J., Cote, I., Parsons, P. J., Patriarca, M., Taylor, A., & Weykamp, C. (2014). Harmonization and transferability of performance assessment: experience from four serum aluminum proficiency testing schemes. Accreditation and Quality Assurance, 19(3), 169-174. https://doi.org/10.1007/s00769-014-1049-4
Aslan, D., Yilmazturk, G. C., Akalin, N., Buyukbese, M. A., Sermez, Y., & Fenkci, S. (2011). Global and national harmonization and standardization of clinical laboratory testings: The example of HbA1c. Turkish Journal of Biochemistry-Turk Biyokimya Dergisi, 36(4), 374-383 https://doi.org/10.1016/j.jmoldx.2019.04.002
Baadenhuijsen, H., Scholten, R., Willems, H. L., Weykamp, C. W., & Jansen, R. T. (2000). A model for harmonization of routine clinical chemistry results between clinical laboratories. Ann Clin Biochem, 37 ( Pt 3), 330-337. http://www.ncbi.nlm.nih.gov/pubmed/10817247
Bachmann, L. M., Yu, M., Boyd, J. C., Bruns, D. E., & Miller, W. G. (2017). State of Harmonization of 24 Serum Albumin Measurement Procedures and Implications for Medical Decisions. Clin Chem, 63(3), 770-779. https://doi.org/10.1373/clinchem.2016.262899
Back, S. E., Nilsson, J. E., Fex, G., Jeppson, J. O., Rosen, U., Tryding, N., von Schenck, H., & Norlund, L. (1999). Towards common reference intervals in clinical chemistry. An attempt at harmonization between three hospital laboratories in Skane, Sweden. Clin Chem Lab Med, 37(5), 573-592. https://doi.org/10.1515/CCLM.1999.091
Bjerke, M., Andreasson, U., Kuhlmann, J., Portelius, E., Pannee, J., Lewczuk, P., Umek, R. M., Vanmechelen, E., Vanderstichele, H., Stoops, E., Lewis, J., Vandijck, M., Kostanjevecki, V., Jeromin, A., Salamone, S. J., Schmidt, O., Matzen, A., Madin, K., Eichenlaub, U., . . . Blennow, K. (2016). Assessing the commutability of reference material formats for the harmonization of amyloid-beta measurements. Clin Chem Lab Med, 54(7), 1177-1191. https://doi.org/10.1515/cclm-2015-0733
Burnett, D., & Blair, C. (2001). Standards for he medical laboratory - harmonization and subsidiary. Clin. Chim. Acta, 309, 137-145. http://ac.els-cdn.com/S0009898101005125/1-s2.0-S0009898101005125-main.pdf?_tid=ddd0252e-ca39-11e4-b06a-00000aacb35d&acdnat=1426331241_24f9588b19042a8047a8e88b034e2fd5
Campbell, C. A., & Horvath, A. R. (2014). Harmonization of critical result management in laboratory medicine. Clinica Chimica Acta, 432, 135-147. https://doi.org/10.1016/j.cca.2013.11.004
Cavalier, E. (2018). A Multicenter Study to Evaluate Harmonization of Assays for C-Terminal Telopeptides of Type I Collagen (Ctx): A Report from the Ifcc-Iof Working Group for the Standardization of Bone Marker Assays. Osteoporosis International, 29, S120-S121 https://doi.org/10.1007/s00223-021-00816-5
Cavalier, E., Eastell, R., Jorgensen, N., Tournis, S., Vasikaran, S., Kanis, J. A., Cooper, C., Pottel, H., Makris, K., & Morris, H. (2019). A Multicenter Study to Evaluate Harmonization of Assays for N-Terminal Propeptide of Type I Procollagen (Pinp): A Report from the Ifcc-Iof Working Group for the Standardization of Bone Marker Assays. Osteoporosis International, 30, S532-S532 https://doi.org/10.1515/cclm-2019-0174
Ceriotti, F., & Cobbaert, C. (2018). Harmonization of External Quality Assessment Schemes and their role - clinical chemistry and beyond. Clin Chem Lab Med, 56(10), 1587-1590. https://doi.org/10.1515/cclm-2018-0265
Christenson, R. H., Duh, S. H., Apple, F. S., Bodor, G. S., Bunk, D. M., Panteghini, M., Welch, M. J., Wu, A. H., & Kahn, S. E. (2006). Toward standardization of cardiac troponin I measurements part II: assessing commutability of candidate reference materials and harmonization of cardiac troponin I assays. Clin Chem, 52(9), 1685-1692. https://doi.org/10.1373/clinchem.2006.068437
Church, D. L., & Naugler, C. (2019). Benefits and risks of standardization, harmonization and conformity to opinion in clinical laboratories. Critical Reviews in Clinical Laboratory Sciences, 56(5), 287-306. https://doi.org/10.1080/10408363.2019.1615408
Clemmons, D. R., Bruns, D. E., & Comm, C. (2011). The Consensus Statement on the Standardization and Evaluation of Growth Hormone and Insulin-like Growth Factor Assays Lacks a Recommendation to Attempt Efficacious Harmonization Reply. Clin Chem, 57(10), 1463-1464. https://doi.org/10.1373/clinchem.2011.170860
Clerico, A., Ripoli, A., Masotti, S., Prontera, C., Storti, S., Fortunato, A., Buzzi, P., Casagranda, I., Franzini, M., Ndreu, R., Zucchelli, G. C., Zaninotto, M., & Plebani, M. (2016). Pilot study on harmonization of cardiac troponin I immunoassays using patients and quality control plasma samples. On behalf of the Italian Section of the European Ligand Assay Society (ELAS) and of the Study Group on Cardiovascular Biomarkers of the Societa Italiana di Biochimica Clinica (SIBioC). Clin Chim Acta, 456, 42-48. https://doi.org/10.1016/j.cca.2016.02.017
Clerico, A., Ripoli, A., Zucchelli, G. C., & Plebani, M. (2015). Harmonization protocols for thyroid stimulating hormone (TSH) immunoassays: different approaches based on the consensus mean value. Clin Chem Lab Med, 53(3), 377-382. https://doi.org/10.1515/cclm-2014-0586
Cobbaert, C., Smit, N., & Gillery, P. (2018). Metrological traceability and harmonization of medical tests: a quantum leap forward is needed to keep pace with globalization and stringent IVD-regulations in the 21st century! Clinical Chemistry and Laboratory Medicine, 56(10), 1598-1602. https://doi.org/10.1515/cclm-2018-0343
Cobbaert, C., Weykamp, C., Franck, P., de Jonge, R., Kuypers, A., Steigstra, H., Klein Gunnewiek, J., van Loon, D., & Jansen, R. (2012). Systematic monitoring of standardization and harmonization status with commutable EQA-samples--five year experience from the Netherlands. Clin Chim Acta, 414, 234-240. https://doi.org/10.1016/j.cca.2012.09.027
Cornes, M. P., Church, S., van Dongen-Lases, E., Grankvist, K., Guimaraes, J. T., Ibarz, M., Kovalevskaya, S., Kristensen, G. B., Lippi, G., Nybo, M., Sprongl, L., Sumarac, Z., Simundic, A. M., Working Group for Preanalytical, P., European Federation of Clinical, C., & Laboratory, M. (2016). The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem, 53(Pt 5), 539-547. https://doi.org/10.1177/0004563216643969
Cornes, M. P., Church, S., van Dongen-Lases, E., Grankvist, K., Guimaraes, J. T., Ibarz, M., Kovalevskaya, S., Kristensen, G. B. B., Lippi, G., Nybo, M., Sprongl, L., Sumarac, Z., Simundic, A. M., Phase, W. G. P., & Chem, E. F. C. (2016). The role of European Federation of Clinical Chemistry and Laboratory Medicine Working Group for Preanalytical Phase in standardization and harmonization of the preanalytical phase in Europe. Ann Clin Biochem, 53(5), 539-547. https://doi.org/10.1177/0004563216643969
Cox, M. G., Kamvissis, S., Milton, M. J. T., & Vargha, G. (2004). Harmonization of correlated calibration curves with an application to the analysis of natural gases. Advanced Mathematical & Computational Tools in Metrology Vi, 66, 52-66. https://doi.org/Doi 10.1142/9789812702647_0005
Cwiklinska, A., Dabrowska, H., Kowalski, R., Kuchta, A., Kortas-Stempak, B., Fijalkowska, A., Bednarczuk, G., & Jankowski, M. (2018). Harmonization of urine albumin/creatinine ratio (ACR) results: a study based on an external quality assessment program in Polish laboratories. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0102
Dati, F., & Brand, B. (2000). Standardization activities for harmonization of test results. Clinica Chimica Acta, 297(1-2), 239-249. https://doi.org/10.1016/S0009-8981(00)00250-3
Dolci, A., & Panteghini, M. (2014). Harmonization of automated hemolysis index assessment and use: Is it possible? Clinica Chimica Acta, 432, 38-43. https://doi.org/10.1016/j.cca.2013.10.012
Dybkaer, R. (1995a). Harmonization of nomenclature and definitions in reference measurement systems. European Journal of Clinical Chemistry and Clinical Biochemistry, 33(12), 995-998 https://pubmed.ncbi.nlm.nih.gov/8845435/
Dybkaer, R. (1995b). Reference materials and reference measurement systems in laboratory medicine. Harmonization of nomenclature and definitions in reference measurement systems. Eur J Clin Chem Clin Biochem, 33(12), 995-998. http://www.ncbi.nlm.nih.gov/pubmed/8845435
Favaloro, E. J., Jennings, I., Olson, J., Van Cott, E. M., Bonar, R., Gosselin, R., & Meijer, P. (2018). Towards harmonization of external quality assessment/proficiency testing in hemostasis. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0077
Favaloro, E. J., Jennings, I., Olson, J., Van Cott, E. M., Bonar, R., Gosselin, R., & Meijer, P. (2019). Towards harmonization of external quality assessment/proficiency testing in hemostasis. Clinical Chemistry and Laboratory Medicine, 57(1), 115-126. https://doi.org/10.1515/cclm-2018-0077
Favaloro, E. J., McVicker, W., Zhang, Y., Hamdam, S., Huynh, M., Peris, P., O'Neal, M., & Hocker, N. (2012). Improving the inter-laboratory harmonization of the international normalized ratio (INR): utilizing the concept of transference to estimate and/or validate international sensitivity index (ISI) and mean normal prothrombin time (MNPT) values and/or to eliminate measurement bias. Clin Lab Sci, 25(1), 13-25. http://www.ncbi.nlm.nih.gov/pubmed/22458045
Favaloro, E. J., Plebani, M., & Lippi, G. (2014a). Standardization and Harmonization of Antiphospholipid Antibody Assays. Semin Thromb Hemost, 40(2), 161-162. https://doi.org/10.1055/s-0033-1364184
Griffith, L. E., van den Heuvel, E., Raina, P., Fortier, I., Sohel, N., Hofer, S. M., Payette, H., Wolfson, C., Belleville, S., Kenny, M., & Doiron, D. (2016). Comparison of Standardization Methods for the Harmonization of Phenotype Data: An Application to Cognitive Measures. American Journal of Epidemiology, 184(10), 770-778. https://doi.org/10.1093/aje/kww098
Hansson, L. O., Flodin, M., Larsson, A., Althaus, H., Blirup-Jensen, S., Schmidt, C., Zegers, I., Lindstrom, V., & Grubb, A. (2011). 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. Clinical Chemistry and Laboratory Medicine, 49, S557-S557 https://doi.org/10.1515/CCLM.2010.318
Hoffmann, G., Klawonn, F., Lichtinghagen, R., & Orth, M. (2018). No mathematical shortcuts for standardization or harmonization of laboratory measurements Reply. Journal of Laboratory Medicine, 42(1-2), 63-65. https://doi.org/10.1515/labmed-2018-0011
Hubert, P., Nguyen-Huu, J. J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., & Valat, L. (2004). Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - part I. Journal of Pharmaceutical and Biomedical Analysis, 36(3), 579-586. https://doi.org/10.1016/j.jpba.2004.07.027
Hubert, P., Nguyen-Huu, J. J., Boulanger, B., Chapuzet, E., Chiap, P., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Lallier, M., Laurentie, M., Mercier, N., Muzard, G., Nivet, C., Valat, L., & Rozet, E. (2007). Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part II. Journal of Pharmaceutical and Biomedical Analysis, 45(1), 70-81. https://doi.org/DOI 10.1016/j.jpba.2007.06.013
Hubert, P., Nguyen-Huu, J. J., Boulanger, B., Chapuzet, E., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., & Rozet, E. (2008). Harmonization of strategies for the validation of quantitative analytical procedures: A SFSTP proposal Part IV. Examples of application. Journal of Pharmaceutical and Biomedical Analysis, 48(3), 760-771. https://doi.org/DOI 10.1016/j.jpba.2008.07.018
Hubert, P., Nguyen-Huu, J. J., Boulangerc, B., Chapuzet, E., Cohen, N., Compagnon, P. A., Dewe, W., Feinberg, M., Laurentie, M., Mercier, N., Muzard, G., Valat, L., & Rozet, E. (2007). Harmonization of strategies for the validation of quantitative analytical procedures - A SFSTP proposal - Part III. Journal of Pharmaceutical and Biomedical Analysis, 45(1), 82-96. https://doi.org/DOI 10.1016/j.jpba.2007.06.032
Ichihara, K. (2014). Statistical considerations for harmonization of the global multicenter study on reference values. Clinica Chimica Acta, 432, 108-118. https://doi.org/10.1016/j.cca.2014.01.025
Jacobs, J. F. M., & Bossuyt, X. (2018). Standardization and harmonization of autoimmune diagnostics. Clinical Chemistry and Laboratory Medicine, 56(10), 1563-1567. https://doi.org/10.1515/cclm-2018-0807
Johnson, A. M. (2010). Necessity for high-quality reference materials in the harmonization of laboratory assays. Clin Chem Lab Med, 48(6), 747-748. https://doi.org/10.1515/CCLM.2010.180
Jones, G. R. D. (2017). The role of EQA in harmonization in laboratory medicine - a global effort. Biochemia Medica, 27(1), 23-29. https://doi.org/10.11613/Bm.2017.004
Kashiwagi, A., Kasuga, M., Araki, E., Oka, Y., Hanafusa, T., Ito, H., Tominaga, M., Oikawa, S., Noda, M., Kawamura, T., Sanke, T., Namba, M., Hashiramoto, M., Sasahara, T., Nishio, Y., Kuwa, K., Ueki, K., Takei, I., Umemoto, M., . . . Soc, J. D. (2012). International clinical harmonization of glycated hemoglobin in Japan: From Japan Diabetes Society to National Glycohemoglobin Standardization Program values. Journal of Diabetes Investigation, 3(1), 39-40. https://doi.org/10.1111/j.2040-1124.2012.00207.x
Kaus, R. (1998). Detection limits and quantitation limits in the view of international harmonization and the consequences for analytical laboratories. Accreditation and Quality Assurance, 3(4), 150-154. https://doi.org/DOI 10.1007/s007690050209
Keever-Taylor, C. A., Slaper-Cortenbach, I., Celluzzi, C., Loper, K., Aljurf, M., Schwartz, J., McGrath, E., Eldridge, P., & Alliance for Harmonisation of Cellular Therapy, A. (2015). Training practices of cell processing laboratory staff: analysis of a survey by the Alliance for Harmonization of Cellular Therapy Accreditation. Cytotherapy, 17(12), 1831-1844. https://doi.org/10.1016/j.jcyt.2015.08.006
Khorovskaia, L. A., Kallner, A., & Emanuel, V. L. (2008). [Harmonization in laboratory medicine: a current approach to improving the quality of clinical and laboratory studies]. Klin Lab Diagn(3), 25-32. http://www.ncbi.nlm.nih.gov/pubmed/18450081
Kilpatrick, E. S., & Sandberg, S. (2018). An overview of EFLM harmonization activities in Europe. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0098
Klee, G. G. (2010). Harmonization and Standardization of Thyroid Function Tests. Clin Chem, 56(6), 879-880. https://doi.org/10.1373/clinchem.2010.145540
Koerbin, G., Sikaris, K., Jones, G. R. D., Flatman, R., Tate, J. R., & Intervals, A. H. C. f. C. R. (2018). An update report on the harmonization of adult reference intervals in Australasia. Clin Chem Lab Med, 57(1), 38-41. https://doi.org/10.1515/cclm-2017-0920
Koerbin, G., Sikaris, K., Jones, G. R. D., Flatman, R., Tate, J. R., & Ref, A. H. C. C. (2019). An update report on the harmonization of adult reference intervals in Australasia. Clinical Chemistry and Laboratory Medicine, 57(1), 38-41. https://doi.org/10.1515/cclm-2017-0920
Kokshoorn, B., Aarts, L. H. J., Ansell, R., Connolly, E., Drotz, W., Kloosterman, A. D., McKenna, L. G., Szkuta, B., & van Oorschot, R. A. H. (2018). Sharing data on DNA transfer, persistence, prevalence and recovery: Arguments for harmonization and standardization. Forensic Science International-Genetics, 37, 260-269. https://doi.org/10.1016/j.fsigen.2018.09.006
Lewis, S. M. (1990). Standardization and Harmonization of the Blood-Count - the Role of International Committee for Standardization in Hematology (Icsh). European Journal of Haematology, 45, 9-13 https://doi.org/10.1111/j.1600-0609.1990.tb01520.x
Lippi, G., Simundic, A. M., European Federation for Clinical, C., & Laboratory Medicine Working Group for Preanalytical, P. (2017). The EFLM strategy for harmonization of the preanalytical phase. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2017-0277
Massambu, C., & Mwangi, C. (2009). The Tanzania experience: clinical laboratory testing harmonization and equipment standardization at different levels of a tiered health laboratory system. American journal of clinical pathology, 131(6), 861-866. https://doi.org/10.1309/AJCP3ZAAFUPCIXIG
McLawhon, R. W. (2011). Patient safety and clinical effectiveness as imperatives for achieving harmonization inside and outside the clinical laboratory. Clin Chem, 57(7), 936-938. https://doi.org/10.1373/clinchem.2011.166041
Miller, W. G. (2009). The role of proficiency testing in achieving standardization and harmonization between laboratories. Clinical biochemistry, 42(4-5), 232-235. https://doi.org/10.1016/j.clinbiochem.2008.09.004
Miller, W. G., Eckfeldt, J. H., Passarelli, J., Rosner, W., & Young, I. S. (2013). Harmonization of Test Results: What Are the Challenges; How Can We Make It Better? Clin Chem. https://doi.org/clinchem.2012.20118610.1373/clinchem.2012.201186
Miller, W. G., Eckfeldt, J. H., Passarelli, J., Rosner, W., & Young, I. S. (2014). Harmonization of Test Results: What Are the Challenges; How Can We Make It Better? Clin Chem, 60(7), 923-927. https://doi.org/10.1373/clinchem.2012.201186
Miller, W. G., & Greenberg, N. (2021). Harmonization and Standardization: Where Are We Now? J Appl Lab Med, 6(2), 510-521. https://doi.org/10.1093/jalm/jfaa189
Miller, W. G., Myers, G. L., Ashwood, E. R., Killeen, A. A., Wang, E., Ehlers, G. W., Hassemer, D., Lo, S. F., Seccombe, D., Siekmann, L., Thienpont, L. M., & Toth, A. (2008). State of the art in trueness and interlaboratory harmonization for 10 analytes in general clinical chemistry. Arch Pathol Lab Med, 132(5), 838-846 https://doi.org/10.5858/2008-132-838-SOTAIT
Miller, W. G., Myers, G. L., Lou Gantzer, M., Kahn, S. E., Schonbrunner, E. R., Thienpont, L. M., Bunk, D. M., Christenson, R. H., Eckfeldt, J. H., Lo, S. F., Nubling, C. M., & Sturgeon, C. M. (2011). Roadmap for harmonization of clinical laboratory measurement procedures. Clin Chem, 57(8), 1108-1117. https://doi.org/10.1373/clinchem.2011.164012
Mitani, Y., Lara-Manzano, J. V., & Rodriguez-Lopez, A. (2008). Proficiency testing scheme for the harmonization and comparability of analytical measurements. Accreditation and Quality Assurance, 13(7), 421-426. https://doi.org/10.1007/s00769-008-0398-2
Myara, A., Guechot, J., Imbert-Bismut, F., Lasnier, E., Piton, A., Voitot, H., & Ferard, G. (2004). Harmonization of liver enzyme results: calibration for aminotransferases and gamma glutamyltransferase. J Hepatol, 41(3), 501-502. https://doi.org/10.1016/j.jhep.2004.04.036
Myers, G. L., & Miller, W. G. (2016). The International Consortium for Harmonization of Clinical Laboratory Results (ICHCLR) - A Pathway for Harmonization. eJIFCC, 27(1), 30-36. https://www.ncbi.nlm.nih.gov/pubmed/27683504
Myers, G. L., & Miller, W. G. (2018). The roadmap for harmonization: status of the International Consortium for Harmonization o Clinical Laboratory Results. Clinical Chemistry and Laboratory Medicine, 56(10), 1667-1672. https://doi.org/10.1515/cclm-2017-0907
Netzel, B. C., Grant, R. P., Hoofnagle, A. N., Rockwood, A. L., Shuford, C. M., & Grebe, S. K. G. (2016). First Steps toward Harmonization of LC-MS/MS Thyroglobulin Assays. Clin Chem, 62(1), 297-299. https://doi.org/10.1373/clinchem.2015.245266
Padoan, A., Clerico, A., Zaninotto, M., Trenti, T., Tozzoli, R., Aloe, R., Alfano, A., Rizzardi, S., Dittadi, R., Migliardi, M., Bagnasco, M., & Plebani, M. (2020). Percentile transformation and recalibration functions allow harmonization of thyroid-stimulating hormone (TSH) immunoassay results. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2019-1167
Pamukcuoglu, M., Falay, M., Urlu, S. M., Ucar, M. A., Ceren, F., Dagdas, S., & Ozet, G. (2017). What We Can Do to Make a Standardization and Harmonization of Aptt? Haematologica, 102, 830-830 https://library.ehaweb.org/eha/2017/22nd/182803/merve.what.we.can.do.to.make.a.standardization.and.harmonization.of.aptt.html
Plebani, M. (2013). Harmonization in laboratory medicine: the complete picture. Clin Chem Lab Med, 51(4), 741-751. https://doi.org/10.1515/cclm-2013-0075
Plebani, M. (2015). Harmonization in laboratory medicine: Requests, samples, measurements and reports. Crit Rev Clin Lab Sci, 1-13. https://doi.org/10.3109/10408363.2015.1116851
Plebani, M. (2016). Harmonization in laboratory medicine: Requests, samples, measurements and reports. Crit Rev Clin Lab Sci, 53(3), 184-196. https://doi.org/10.3109/10408363.2015.1116851
Plebani, M. (2018). Harmonization in laboratory medicine: more than clinical chemistry? Clinical Chemistry and Laboratory Medicine, 56(10), 1579-1586. https://doi.org/10.1515/cclm-2017-0865
Plebani, M., Astion, M. L., Barth, J. H., Chen, W., de Oliveira Galoro, C. A., Escuer, M. I., Ivanov, A., Miller, W. G., Petinos, P., Sciacovelli, L., Shcolnik, W., Simundic, A. M., & Sumarac, Z. (2014). Harmonization of quality indicators in laboratory medicine. A preliminary consensus. Clin Chem Lab Med, 52(7), 951-958. https://doi.org/10.1515/cclm-2014-0142
Plebani, M., Chiozza, M. L., & Sciacovelli, L. (2013). Towards harmonization of quality indicators in laboratory medicine. Clin Chem Lab Med, 51(1), 187-195. https://doi.org/10.1515/cclm-2012-0582
Plebani, M., Sciacovelli, L., Aita, A., & Chiozza, M. L. (2014). Harmonization of pre-analytical quality indicators. Biochem Med (Zagreb), 24(1), 105-113. https://doi.org/10.11613/BM.2014.012
Rami, L., Roura, M., & Canalias, F. (2012). Evaluation of commutability of several materials for harmonization alkaline phosphatase catalytic concentration measurements. Clin Chim Acta, 413(15-16), 1249-1254. https://doi.org/10.1016/j.cca.2012.04.004
Royal, P. D. (1994). Harmonization of good laboratory practice requirements and laboratory accreditation programs. Qual Assur, 3(3), 312-315. http://www.ncbi.nlm.nih.gov/pubmed/7804653
Sanders, G. T., Jansen, R. T., Beastall, G., Gurr, E., Kenny, D., Kohse, K. P., & Zerah, S. (1999). Recent activities of EC4 in the harmonization of clinical chemistry in the European Union. Clin Chem Lab Med, 37(4), 477-480. https://doi.org/10.1515/CCLM.1999.077
Savoie, N., Garofolo, F., van Amsterdam, P., Bansal, S., Beaver, C., Bedford, P., Booth, B. P., Evans, C., Jemal, M., Lefebvre, M., Lopes de Silva, A. L., Lowes, S., Marini, J. C., Masse, R., Mawer, L., Ormsby, E., Rocci, M. L., Jr., Viswanathan, C., Wakelin-Smith, J., . . . Woolf, E. (2010). 2010 white paper on recent issues in regulated bioanalysis & global harmonization of bioanalytical guidance. Bioanalysis, 2(12), 1945-1960. https://doi.org/10.4155/bio.10.164
Scharnhorst, V., Apperloo, J., Baadenhuijsen, H., & Vader, H. L. (2004). Multicenter evaluation of the commutability of a potential reference material for harmonization of enzyme activities. Clin Chem Lab Med, 42(12), 1401-1407. https://doi.org/10.1515/CCLM.2004.261
Schuurs, T. A., Koelewijn, R., Brienen, E. A. T., Kortbeek, T., Mank, T. G., Mulder, B., Stelma, F. F., van Lieshout, L., & van Hellemond, J. J. (2018). Harmonization of PCR-based detection of intestinal pathogens: experiences from the Dutch external quality assessment scheme on molecular diagnosis of protozoa in stool samples. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2017-1057
Secchiero, S., Sciacovelli, L., & Plebani, M. (2018). Harmonization of units and reference intervals of plasma proteins: state of the art from an External Quality Assessment Scheme. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2017-1172
Secchiero, S., Sciacovelli, L., & Plebani, M. (2019). Harmonization of units and reference intervals of plasma proteins: state of the art from an External Quality Assessment Scheme. Clinical Chemistry and Laboratory Medicine, 57(1), 95-105. https://doi.org/10.1515/cclm-2017-1172
Silverman, S. (2016). Standard Reference Markers: Clinical Role and Research Goals for Harmonization and Standardization. Osteoporosis International, 27, S565-S566.
Stavelin, A., & Sandberg, S. (2018). Harmonization activities of Noklus - a quality improvement organization for point-of-care laboratory examinations. Clin Chem Lab Med. https://doi.org/10.1515/cclm-2018-0061
Stavelin, A., & Sandberg, S. (2019). Harmonization activities of Noklus - a quality improvement organization for point-of-care laboratory examinations. Clinical Chemistry and Laboratory Medicine, 57(1), 106-114. https://doi.org/10.1515/cclm-2018-0061
Stegnar, M., & Bozic, M. (2008). Determination of D-dimer by different quantitative assays-A harmonization exercise. Biochemia Medica, 18(2), 216-223 https://doi.org/10.11613/BM.2008.022
Stockl, D., Van Uytfanghe, K., Van Aelst, S., & Thienpont, L. M. (2014). A statistical basis for harmonization of thyroid stimulating hormone immunoassays using a robust factor analysis model. Clin Chem Lab Med, 52(7), 965-972. https://doi.org/10.1515/cclm-2013-1038
Sundqvist, B., Bengtsson, U. A., Wisselink, H. J., Peeters, B. P., van Rotterdam, B., Kampert, E., Bereczky, S., Johan Olsson, N. G., Szekely Bjorndal, A., Zini, S., Allix, S., & Knutsson, R. (2013). Harmonization of European laboratory response networks by implementing CWA 15793: use of a gap analysis and an "insider" exercise as tools. Biosecur Bioterror, 11 Suppl 1, S36-44. https://doi.org/10.1089/bsp.2013.0020
Tate, J. R., Johnson, R., Barth, J., & Panteghini, M. (2013). Harmonization of laboratory testing - Current achievements and future strategies. Clin Chim Acta. https://doi.org/S0009-8981(13)00331-810.1016/j.cca.2013.08.021
Tate, J. R., Johnson, R., Barth, J., & Panteghini, M. (2014a). Harmonization of laboratory testing - Current achievements and future strategies. Clin Chim Acta, 432, 4-7. https://doi.org/10.1016/j.cca.2013.08.021
Tate, J. R., Johnson, R., Barth, J. H., & Panteghini, M. (2014b). "Harmonization of laboratory testing - A global activity". Clin Chim Acta, 432, 1-3. https://doi.org/10.1016/j.cca.2014.02.006
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015a). Standardization of Free T4 and Harmonization of TSH Measurements: A Request for Input from Endocrinologists and Other Physicians. Eur Thyroid J, 4(4), 271-272. https://doi.org/10.1159/000440614
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015b). Standardization of Free T-4 and Harmonization of TSH Measurements: A Request for Input from Endocrinologists and Other Physicians. European Thyroid Journal, 4(4), 271-272. https://doi.org/10.1159/000440614
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015c). Standardization of Free Thyroxine and Harmonization of Thyrotropin Measurements: A Request for Input from Endocrinologists and Other Physicians. Thyroid, 25(12), 1379-1380. https://doi.org/10.1089/thy.2015.0309
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015d). Standardization of FT4 and harmonization of TSH measurements - a request for input from endocrinologists and other physicians. Endocr J, 62(10), 855-856. https://doi.org/10.1507/endocrj.EJ15-0382
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015e). Standardization of FT4 and harmonization of TSH measurements - a request for input from endocrinologists and other physicians. Endocrine Journal, 62(10), 855-856. https://doi.org/DOI 10.1507/endocrj.EJ15-0382
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015f). Standardization of FT4 and harmonization of TSH measurements - a request for input from endocrinologists and other physicians [Opinion]. Endocr J, 62(10), 855-856. https://doi.org/10.1507/endocrj.EJ15-0382
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015g). Standardization of FT4 and harmonization of TSH measurements: a request for input from endocrinologists and other physicians. Endocrine, 50(3), 826-827. https://doi.org/10.1007/s12020-015-0752-1
Thienpont, L. M., Faix, J. D., & Beastall, G. (2015h). Standardization of FT4 and harmonization of TSH measurements: a request for input from endocrinologists and other physicians. Endocrine, 50(3), 826-827. https://doi.org/10.1007/s12020-015-0752-1
Thienpont, L. M., Faix, J. D., & Beastall, G. (2016a). Standardization of FT4 and harmonization of TSH measurements - a request for input from endocrinologists and other physicians. Clinical Endocrinology, 84(2), 305-306. https://doi.org/10.1111/cen.12861
Thienpont, L. M., Faix, J. D., & Beastall, G. (2016b). Standardization of FT4 and Harmonization of TSH Measurements--A Request for Input from Endocrinologists and Other Physicians. Exp Clin Endocrinol Diabetes, 124(1), 61-62. https://doi.org/10.1055/s-0035-1564102
Thienpont, L. M., Van Uytfanghe, K., De Grande, L. A. C., Reynders, D., Das, B., Faix, J. D., MacKenzie, F., Decallonne, B., Hishinuma, A., Lapauw, B., Taelman, P., Van Crombrugge, P., Van den Bruel, A., Velkeniers, B., Williams, P., & Thyroid, I. C. S. (2017). Harmonization of Serum Thyroid-Stimulating Hormone Measurements Paves the Way for the Adoption of a More Uniform Reference Interval. Clin Chem, 63(7), 1248-1260. https://doi.org/10.1373/clinchem.2016.269456
Timmerman, P., Lowes, S., Fast, D. M., & Garofolo, F. (2010). Request for global harmonization of the guidance for Bioanalytical Method Validation and sample analysis [Letter]. Bioanalysis, 2(4), 683. https://doi.org/10.4155/bio.10.34
van den Besselaar, A. M., Haas, F. J., & Kuypers, A. W. (2012). Harmonization and external quality assessment of antithrombin activity assays. Thromb Res, 129(2), 187-191. https://doi.org/10.1016/j.thromres.2011.06.007
van den Besselaar, A. M., Haas, F. J., van der Graaf, F., & Kuypers, A. W. (2009). Harmonization of fibrinogen assay results: study within the framework of the Dutch project 'Calibration 2000'. Int J Lab Hematol, 31(5), 513-520. https://doi.org/10.1111/j.1751-553X.2008.01070.x
van den Besselaar, A. M. H. P., Haas, F. J. L. M., van der Graaf, F., & Kuypers, A. W. H. M. (2009). Harmonization of fibrinogen assay results: study within the framework of the Dutch project 'Calibration 2000'. International Journal of Laboratory Hematology, 31(5), 513-520. https://doi.org/10.1111/j.1751-553X.2008.01070.x
Van Houcke, S. K., Van Aelst, S., Van Uytfanghe, K., & Thienpont, L. M. (2013). 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, 51(5), e103-105. https://doi.org/10.1515/cclm-2012-0661
Vesper, H. W., Myers, G. L., & Miller, W. G. (2016a). Current practices and challenges in the standardization and harmonization of clinical laboratory tests. American Journal of Clinical Nutrition, 104(3), 907s-912s. https://doi.org/10.3945/ajcn.115.110387
Vesper, H. W., Myers, G. L., & Miller, W. G. (2016b). Current practices and challenges in the standardization and harmonization of clinical laboratory tests. American Journal of Clinical Nutrition, 104 Suppl 3, 907S-912S. https://doi.org/10.3945/ajcn.115.110387
Vidali, M., Carobene, A., Esposito, S. A., Napolitano, G., Caracciolo, A., Seghezzi, M., Previtali, G., Lippi, G., & Buoro, S. (2020). Standardization and harmonization in hematology: Instrument alignment, quality control materials, and commutability issue. International Journal of Laboratory Hematology. https://doi.org/10.1111/ijih.13379
Weykamp, C., Eckfeldt, J., Vesper, H., Thienpont, L., Burns, C., Caliendo, A., Ciesiolka, C., & Passarelli, J. (2013). Toolbox of technical procedures to be considered when developing a process to achieve harmonization for a measurand. http://www.harmonization.net/Resource/Documents/Tool_Box_2013.pdf
Weykamp, C., Wielders, J., Helander, A., Anton, R. F., Bianchi, V., Jeppsson, J. O., Siebelder, C., Whitfield, J. B., Schellenberg, F., & Transferrin, I. W. G. o. S. o. C.-D. (2014). 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. Clin Chem, 60(7), 945-953. https://doi.org/10.1373/clinchem.2014.221531
Weykamp, C., Wielders, J. P. M., Helander, A., Anton, R. F., Bianchi, V., Jeppsson, J. O., Siebelder, C., Whitfield, J. B., Schellenberg, F., & C, I. W. G. S. (2013). 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. Clinical Chemistry and Laboratory Medicine, 51(5), 991-996. https://doi.org/10.1515/cclm-2012-0767
Winter, C., Ganslandt, T., & Bietenbeck, A. (2018). No mathematical shortcuts for standardization or harmonization of laboratory measurements. Journal of Laboratory Medicine, 42(1-2), 59-62. https://doi.org/10.1515/labmed-2017-0122