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Original Article

Immunoassay Standardization

Pages 33-46 | Published online: 08 Jul 2009

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Konstantinos Makris, Alexander Haliassos, Maria Chondrogianni & Georgios Tsivgoulis. (2018) Blood biomarkers in ischemic stroke: potential role and challenges in clinical practice and research. Critical Reviews in Clinical Laboratory Sciences 55:5, pages 294-328.
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R. Dybkaer. (1996) Quantities and units for biological reference materials used with in vitro diagnostic measuring systems for antibodies. Scandinavian Journal of Clinical and Laboratory Investigation 56:5, pages 385-391.
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Mario Plebani & Claudio Galli. (2022) The never-ending quest for antibody assays standardization and appropriate measurement units. Clinical Chemistry and Laboratory Medicine (CCLM) 60:7, pages 959-960.
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Wayne Dimech. (2021) The Standardization and Control of Serology and Nucleic Acid Testing for Infectious Diseases. Clinical Microbiology Reviews 34:4.
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Aldo Clerico, Martina Zaninotto, Claudio Passino, Andrea Padoan, Marco Migliardi & Mario Plebani. 2021. 215 252 .
Aldo Clerico, Martina Zaninotto, Andrea Padoan, Rudina Ndreu, Veronica Musetti, Silvia Masotti, Concetta Prontera, Claudio Passino, Gian Carlo Zucchelli, Mario Plebani & Marco Migliardi. (2020) Harmonization of two hs-cTnI methods based on recalibration of measured quality control and clinical samples. Clinica Chimica Acta 510, pages 150-156.
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Adriana Amaro, Andrea Petretto, Giovanna Angelini & Ulrich Pfeffer. 2016. Translational Medicine. Translational Medicine 67 108 .
E. Höfel, T. Rieker, J. S. Suchodolski, J. M. Steiner & K. Burke. (2018) Messung kaniner und feliner PankreaslipaseImmunreaktivität – analytischer Vergleich neuer kommerzieller Tests mit etablierten Assays. Tierärztliche Praxis Ausgabe K: Kleintiere / Heimtiere 43:06, pages 399-408.
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P. W. Strike. 2014. Wiley StatsRef: Statistics Reference Online. Wiley StatsRef: Statistics Reference Online.
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Jonathan G Middle. (2013) Journal Editors’ requirements for full descriptions of laboratory methods need to include information on metrological traceability and analytical specificity. Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 50:1, pages 87-88.
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Roger Ekins. 2013. The Immunoassay Handbook. The Immunoassay Handbook 109 121 .
W. Greg MillerGary L. MyersMary Lou GantzerStephen E. KahnE. Ralf SchönbrunnerLinda M. ThienpontDavid M. BunkRobert H. ChristensonJohn H. EckfeldtStanley F. LoC. Micha NüblingCatharine M. Sturgeon. (2012) Translation: Roadmap for Harmonization of Clinical Laboratory Measurement Procedures. Laboratory Medicine Online 2:1, pages 1.
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W Greg Miller, Gary L Myers, Mary Lou Gantzer, Stephen E Kahn, E Ralf Schönbrunner, Linda M Thienpont, David M Bunk, Robert H Christenson, John H Eckfeldt, Stanley F Lo, C Micha Nübling & Catharine M Sturgeon. (2011) Roadmap for Harmonization of Clinical Laboratory Measurement Procedures. Clinical Chemistry 57:8, pages 1108-1117.
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Stacey P. Huth, Roberta Relford, Jörg M. Steiner, Marilyn I. Strong-Townsend & David A. Williams. (2010) ORIGINAL RESEARCH: Analytical validation of an ELISA for measurement of canine pancreas-specific lipase. Veterinary Clinical Pathology 39:3, pages 346-353.
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Ashley B Saunders, Andrew S Hanzlicek, Elizabeth A Martinez, Mark J Stickney, Jörg M Steiner, Jan S Suchodolski & Geoffery T Fosgate. (2009) Assessment of cardiac troponin I and C-reactive protein concentrations associated with anesthetic protocols using sevoflurane or a combination of fentanyl, midazolam, and sevoflurane in dogs. Veterinary Anaesthesia and Analgesia 36:5, pages 449-456.
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Ashley B. Saunders, Brooke E. Smith, Geoffery T. Fosgate, Jan S. Suchodolski & Jörg M. Steiner. (2009) Cardiac troponin I and C-reactive protein concentrations in dogs with severe pulmonic stenosis before and after balloon valvuloplasty. Journal of Veterinary Cardiology 11:1, pages 9-16.
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Linda M. Thienpont. (2008) Accuracy in clinical chemistry – who will kiss Sleeping Beauty awake?. Clinical Chemistry and Laboratory Medicine 46:9.
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Martin Bidlingmaier & Christian J. Strasburger. (2007) Growth hormone assays: current methodologies and their limitations. Pituitary 10:2, pages 115-119.
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Ravinder Sodi. 2006. Advances in Clinical Chemistry Volume 41. Advances in Clinical Chemistry Volume 41 49 122 .
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P. W. Strike. 2005. Encyclopedia of Biostatistics. Encyclopedia of Biostatistics.
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Martin Bidlingmaier, Zida Wu & Christian J. Strasburger. 2005. The Endocrine System in Sports and Exercise. The Endocrine System in Sports and Exercise 36 46 .
Mauro Panteghini. (2004) Current concepts in standardization of cardiac marker immunoassays. Clinical Chemistry and Laboratory Medicine (CCLM) 42:1.
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Jean Lee, Wendell Smith, Gerald Nordblom & Ronald Bowsher. 2003. Biomarkers in Clinical Drug Development. Biomarkers in Clinical Drug Development.
Wayne A Colburn & Jean W Lee. (2003) Biomarkers, Validation and Pharmacokinetic-Pharmacodynamic Modelling. Clinical Pharmacokinetics 42:12, pages 997-1022.
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Mauro Panteghini. 2003. Cardiac Markers. Cardiac Markers 213 229 .
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Catharine M Sturgeon & E Jean McAllister. (2016) Analysis of hCG: Clinical Applications and Assay Requirements. Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 35:4, pages 460-491.
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Jonathan Middle. (2016) Standardization of Steroid Hormone Assays. Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 35:3, pages 354-363.
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Matthew P Rose. (1998) Follicle stimulating hormone. Clinica Chimica Acta 273:2, pages 103-117.
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Jonathan G. Middle, Jean-Claude Libeer, Vladimir Malakhov & Ilkka Penttilä. (1998) Characterisation and Evaluation of External Quality Assessment Scheme Serum. cclm 36:2, pages 119-130.
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Josef S. Smolen, Günter Steiner & Eng M. Tan. (2005) Standards of care: The value and importance of standardization. Arthritis & Rheumatism 40:3, pages 410-412.
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John Seth. (2016) Standardization of Protein Hormone Immunoassays. Annals of Clinical Biochemistry: International Journal of Laboratory Medicine 33:6, pages 482-485.
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P. Niccoli, S. Costagliola, M. C. Patricot, B. Mallet, M. Benahmed & P. Carayon. (2014) European collaborative study of LH assay: 3, Relationship of immunological reactivity, biological activity and charge of human luteinizing hormone(1). Journal of Endocrinological Investigation 19:5, pages 260-267.
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C Charlier & G Plomteux. (1996) La place actuelle de l'immunoanalyse en toxicologie clinique. Immuno-analyse & Biologie Spécialisée 11:4, pages 225-239.
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Roger P. Ekins & Frederick Chu. (1994) Developing multianalyte assays. Trends in Biotechnology 12:3, pages 89-94.
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Robert L. Vessella & Paul H. Lange. (1993) ISSUES IN THE ASSESSMENT OF PSA IMMUNOASSAYS. Urologic Clinics of North America 20:4, pages 607-619.
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S. L. Jeffcoate. (2008) Analytical and clinical significance of peptide hormone heterogeneity with particular reference to growth hormone and luteinizing hormone in serum. Clinical Endocrinology 38:2, pages 113-121.
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Marion Bauernfeind & W. G. Wood. (1993) Evaluation of a Fully Mechanised Immunoassay — Enzymun-Test System ES 300 — and Comparison with In-House Methods for 8 Analytes. Clinical Chemistry and Laboratory Medicine 31:3.
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Canadian Society of Clinical Chemists. (1992) Canadian society of clinical chemists position paper: standardization of selected polypeptide hormone measurements. Clinical Biochemistry 25:6, pages 415-424.
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Göran Nilsson. (2005) Comparison of measurement methods based on a model for the error structure. Journal of Chemometrics 5:6, pages 523-536.
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