272
Views
51
CrossRef citations to date
0
Altmetric
Research Article

Introduction: Strategies to set global quality specifications in laboratory medicine

Pages 477-478 | Published online: 08 Jul 2009

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (3)

Anders Kallner, Astrid Petersmann, Matthias Nauck & Elvar Theodorsson. (2020) Measurement repeatability profiles of eight frequently requested measurands in clinical chemistry determined by duplicate measurements of patient samples. Scandinavian Journal of Clinical and Laboratory Investigation 80:3, pages 202-209.
Read now
Yesim Ozarda, Ken Sikaris, Thomas Streichert & Joseph Macri. (2018) Distinguishing reference intervals and clinical decision limits – A review by the IFCC Committee on Reference Intervals and Decision Limits. Critical Reviews in Clinical Laboratory Sciences 55:6, pages 420-431.
Read now
J. Aguilar, C. Álvarez, J. Morancho‐Zaragoza, R. Prats‐Gimenez, J. P. Ramírez, E. Fernández‐Pardo, L. Martínez, R. Calafell, I. Duran & J. A. Castilla. (2008) Quality specifications for seminal parameters based on clinicians' opinions. Scandinavian Journal of Clinical and Laboratory Investigation 68:1, pages 68-76.
Read now

Articles from other publishers (48)

Ji Zhang, Yang Jiang, Ting Liu, Xiongwei Liu, Hui Huang, Yanxiang Cheng, Jieyan Li, Bangning Cheng, Chungen Qian, Xufu Xiang & Jun‐Fa Xu. (2024) Candidate reference measurement procedure for serum 17‐hydroxyprogesterone quantification via isotope dilution liquid chromatography–tandem mass spectrometry. iLABMED.
Crossref
Alejandra Comins-Boo, Fernando Pérez-Pla, Juan Irure-Ventura, Marcos López-Hoyos, Lydia Blanco-Peris, María del Carmen Martín Alonso & David San Segundo Arribas. (2024) Total error in lymphocyte subpopulations by flow cytometry-based in state of the art using Spanish EQAS data. Clinical Chemistry and Laboratory Medicine (CCLM) 62:2, pages 312-321.
Crossref
Vincenzo Brescia, Angela Pia Cazzolla, Antonietta Fontana, Lucia Varraso, Carmela Capobianco, Roberto Lovero, Lorenzo Lo Muzio, Mario Dioguardi, Maria Felicia Faienza, Vito Crincoli, Francesca Di Serio & Domenico Ciavarella. (2023) Bone Biomarkers Measured on Salivary Matrix: Study of Biological Variability in a Cohort of Young Subjects. Applied Sciences 13:18, pages 10234.
Crossref
Mario Plebani. 2023. Clinical and Laboratory Medicine Textbook. Clinical and Laboratory Medicine Textbook 7 13 .
Mario Plebani. (2022) Control interno de la calidad y garantía externa de la calidad: un gran pasado abre el camino a un brillante futuro. Advances in Laboratory Medicine / Avances en Medicina de Laboratorio 3:3, pages 218-220.
Crossref
Mario Plebani. (2022) Internal quality control and external quality assurance: a great past opens the way to a bright future. Advances in Laboratory Medicine / Avances en Medicina de Laboratorio 3:3, pages 215-217.
Crossref
Carmen Ricós, Pilar Fernandez-Calle, Maria Carmen Perich & James O. Westgard. (2022) Control interno de la calidad – bases del pasado, situación presente y futuras tendencias. Advances in Laboratory Medicine / Avances en Medicina de Laboratorio 3:3, pages 253-262.
Crossref
Anna Carobene, Andrea Campagner, Christian Uccheddu, Giuseppe Banfi, Matteo Vidali & Federico Cabitza. (2022) The multicenter European Biological Variation Study (EuBIVAS): a new glance provided by the Principal Component Analysis (PCA), a machine learning unsupervised algorithms, based on the basic metabolic panel linked measurands. Clinical Chemistry and Laboratory Medicine (CCLM) 60:4, pages 556-568.
Crossref
Anna Carobene, Aasne K. Aarsand, William A. Bartlett, Abdurrahman Coskun, Jorge Diaz-Garzon, Pilar Fernandez-Calle, Elena Guerra, Niels Jonker, Massimo Locatelli, Mario Plebani, Sverre Sandberg & Ferruccio Ceriotti. (2022) The European Biological Variation Study (EuBIVAS): a summary report. Clinical Chemistry and Laboratory Medicine (CCLM) 60:4, pages 505-517.
Crossref
Ashraf Mina, Shanmugam Banukumar & Santiago Vazquez. (2021) A novel practical approach to calculate measurement uncertainty in clinical pathology laboratories using quality control data with the use of biological variation where applicable. Journal of Analytical & Pharmaceutical Research 10:5, pages 196-210.
Crossref
Panagiotis Diamantakos, Kostas Ioannidis, Christos Papanikolaou, Annia Tsolakou, Aimilia Rigakou, Eleni Melliou & Prokopios Magiatis. (2021) A New Definition of the Term “High-Phenolic Olive Oil” Based on Large Scale Statistical Data of Greek Olive Oils Analyzed by qNMR. Molecules 26:4, pages 1115.
Crossref
Leonor Guiñón, Anna Soler, Angel Molina, José Luis Marín, Rosa María López, Judit García-Villoria, Ángeles Sahuquillo & Luisa Alvarez. (2020) Analytical performance specifications based on the state-of-the-art for the newborn screening. Clinica Chimica Acta 510, pages 117-120.
Crossref
Cristiano Ialongo. (2019) Confidence interval of percentiles in skewed distribution. Biochemia medica 29:3, pages 471-482.
Crossref
Cristiano Ialongo. (2019) Confidence interval for quantiles and percentiles. Biochemia medica 29:1, pages 5-17.
Crossref
Anna Carobene, Elena Guerra, Massimo Locatelli, Vito Cucchiara, Alberto Briganti, Aasne K. Aarsand, Abdurrahman Coşkun, Jorge Díaz-Garzón, Pilar Fernandez-Calle, Thomas Røraas, Sverre Sandberg, Niels Jonker & Ferruccio Ceriotti. (2018) Biological variation estimates for prostate specific antigen from the European Biological Variation Study; consequences for diagnosis and monitoring of prostate cancer. Clinica Chimica Acta 486, pages 185-191.
Crossref
Xianzhang Huang, Qiaoxuan Zhang, Songbai Zheng, Jianbing Wang, Liqiao Han, Haibiao Lin, Peifeng Ke, Junhua Zhuang & Zhimin Cao. (2018) Measurement of human serum unconjugated estriol without derivatization using liquid chromatography-tandem mass spectrometry candidate reference method and compared with two immunoassays. Analytical and Bioanalytical Chemistry 410:24, pages 6257-6267.
Crossref
Sten Westgard, Hassan Bayat & James O Westgard. (2018) Analytical Sigma metrics: A review of Six Sigma implementation tools for medical laboratories. Biochemia Medica 28:2.
Crossref
Sara Pasqualetti, Federica Braga & Mauro Panteghini. (2017) Pre-analytical and analytical aspects affecting clinical reliability of plasma glucose results. Clinical Biochemistry 50:10-11, pages 587-594.
Crossref
Giovanni B. Frisoni, Daniela Perani, Stefano Bastianello, Gaetano Bernardi, Corinna Porteri, Marina Boccardi, Stefano F. Cappa, Marco Trabucchi & Alessandro Padovani. (2017) Biomarkers for the diagnosis of Alzheimer's disease in clinical practice: an Italian intersocietal roadmap. Neurobiology of Aging 52, pages 119-131.
Crossref
Mario Plebani. (2016) Towards a new paradigm in laboratory medicine: the five rights. Clinical Chemistry and Laboratory Medicine (CCLM) 54:12, pages 1881-1891.
Crossref
Anna Carobene, Marta Strollo, Niels Jonker, Gerhard Barla, William A. Bartlett, Sverre Sandberg, Marit Sverresdotter Sylte, Thomas Røraas, Una Ørvim Sølvik, Pilar Fernandez-CalleJorge Díaz-GarzónFrancesca Tosato, Mario Plebani, Abdurrahman Coşkun, Mustafa Serteser, Ibrahim Unsal, Ferruccio Ceriotti & on behalf of the Biological Variation Working Group, Europea. (2016) Sample collections from healthy volunteers for biological variation estimates’ update: a new project undertaken by the Working Group on Biological Variation established by the European Federation of Clinical Chemistry and Laboratory Medicine. Clinical Chemistry and Laboratory Medicine (CCLM) 54:10, pages 1599-1608.
Crossref
Michael J Duffy, Catharine M Sturgeon, György Sölétormos, Vivian Barak, Rafael Molina, Daniel F Hayes, Eleftherios P Diamandis & Patrick M M Bossuyt. (2015) Validation of New Cancer Biomarkers: A Position Statement from the European Group on Tumor Markers. Clinical Chemistry 61:6, pages 809-820.
Crossref
Kristin M. Aakre, Michel R. Langlois, Julian H. Barth, Shivani Misra, Joseph Watine & Wytze P. Oosterhuis. (2014) The quality of laboratory aspects of troponin testing in clinical practice guidelines and consensus documents needs to be improved. Clinica Chimica Acta 437, pages 58-61.
Crossref
Anthony A. KilleenTom LongRhona SouersPatricia StyerChristina B. VenturaGeorge G. Klee. (2014) Verifying Performance Characteristics of Quantitative Analytical Systems: Calibration Verification, Linearity, and Analytical Measurement Range. Archives of Pathology & Laboratory Medicine 138:9, pages 1173-1181.
Crossref
Hubert W. Vesper, Julianne C. Botelho, Meghan L. Vidal, Yasamin Rahmani, Linda M. Thienpont & Samuel P. Caudill. (2014) High variability in serum estradiol measurements in men and women. Steroids 82, pages 7-13.
Crossref
Dana Bailey, Victoria Bevilacqua, David A Colantonio, Maria D Pasic, Nandita Perumal, Man Khun Chan & Khosrow Adeli. (2014) Pediatric Within-Day Biological Variation and Quality Specifications for 38 Biochemical Markers in the CALIPER Cohort. Clinical Chemistry 60:3, pages 518-529.
Crossref
O. A. Klimenkova, G. A. Ivanov, G. S. Turkovskiĭ & A. V. Émanuél'. (2014) Choice of standards (purposes) of analytical quality as the first stage of its creation in medical laboratories. Laboratornaya sluzhba 3:4, pages 31.
Crossref
Andrea R. Horvath, Sarah J. Lord, Andrew StJohn, Sverre Sandberg, Christa M. Cobbaert, Stefan Lorenz, Phillip J. Monaghan, Wilma D.J. Verhagen-Kamerbeek, Christoph Ebert & Patrick M.M. Bossuyt. (2014) From biomarkers to medical tests: The changing landscape of test evaluation. Clinica Chimica Acta 427, pages 49-57.
Crossref
Daniel Pineda-Tenor, Emilio José Laserna-Mendieta, Jesús Timón-Zapata, Laura Rodelgo-Jiménez, Raquel Ramos-Corral, Antonio Recio-Montealegre & Manuel Gómez-Serranillos Reus. (2013) Biological variation and reference change values of common clinical chemistry and haematologic laboratory analytes in the elderly population. Clinical Chemistry and Laboratory Medicine (CCLM) 51:4, pages 851-862.
Crossref
Wayne Dimech, Robert Freame, Kathy Smeh & Handan Wand. (2013) A review of the relationship between quality control and donor sample results obtained from serological assays used for screening blood donations for anti-HIV and hepatitis B surface antigen. Accreditation and Quality Assurance 18:1, pages 11-18.
Crossref
Yeo-Min Yun, Julianne Cook Botelho, Donald W Chandler, Alex Katayev, William L Roberts, Frank Z Stanczyk, Hubert W Vesper, Jon M Nakamoto, Luigi Garibaldi, Nigel J Clarke & Robert L Fitzgerald. (2012) Performance Criteria for Testosterone Measurements Based on Biological Variation in Adult Males: Recommendations from the Partnership for the Accurate Testing of Hormones. Clinical Chemistry 58:12, pages 1703-1710.
Crossref
Craig G. Ruaux, Patrick C. Carney, Jan S. Suchodolski & Jörg M. Steiner. (2012) Estimates of biological variation in routinely measured biochemical analytes in clinically healthy dogs. Veterinary Clinical Pathology 41:4, pages 541-547.
Crossref
Mario Plebani & Giuseppe Lippi. (2012) Biological variation and reference change values: an essential piece of the puzzle of laboratory testing. Clinical Chemistry and Laboratory Medicine (CCLM) 50:2.
Crossref
Greg Cooper, Niels DeJonge, Sharon Ehrmeyer, John Yundt-Pacheco, Rob Jansen, Carmen Ricós & Mario Plebani. (2011) Collective opinion paper on findings of the 2010 convocation of experts on laboratory quality. cclm 49:5, pages 793-802.
Crossref
Frédéric Sobas, Norbert Benattar, Audrey Bellisario, Sylvie Marin, Christophe Nougier, Anne Lienhart & Claude Négrier. (2010) Impact of quality control matrix effect: application to the calculation of uncertainty of measurement in one-stage clotting factor VIII assay. Blood Coagulation & Fibrinolysis 21:5, pages 498-501.
Crossref
Lars Björndahl, David Mortimer, Christopher L. R. Barratt, Jose Antonio Castilla, Roelof Menkveld, Ulrik Kvist, Juan G. Alvarez & Trine B. Haugen. 2010. A Practical Guide to Basic Laboratory Andrology. A Practical Guide to Basic Laboratory Andrology 227 248 .
George G Klee. (2010) Establishment of Outcome-Related Analytic Performance Goals. Clinical Chemistry 56:5, pages 714-722.
Crossref
Frédéric Sobas, Audrey Bellisario, Panagiotis Tsiamyrtzis, Anne Lienhart, Christophe Nougier & Claude Négrier. (2010) Bayesian logic in statistical test control: application to coagulation factor VIII assay. Blood Coagulation & Fibrinolysis 21:3, pages 289-295.
Crossref
Anastasia Varvarigou, Sotirios Fouzas, Eleni Skylogianni, Lito Mantagou, Dorothea Bougioukou & Stefanos Mantagos. (2009) Transcutaneous Bilirubin Nomogram for Prediction of Significant Neonatal Hyperbilirubinemia. Pediatrics 124:4, pages 1052-1059.
Crossref
Hubert W Vesper & Linda M Thienpont. (2009) Traceability in Laboratory Medicine. Clinical Chemistry 55:6, pages 1067-1075.
Crossref
Jim R. Bonham. 2008. Laboratory Guide to the Methods in Biochemical Genetics. Laboratory Guide to the Methods in Biochemical Genetics 7 22 .
J.A. Castilla, C. Álvarez, J. Aguilar, C. González-Varea, M.C. Gonzalvo & L. Martínez. (2006) Influence of analytical and biological variation on the clinical interpretation of seminal parameters. Human Reproduction 21:4, pages 847-851.
Crossref
Dinesh K Talwar, Mohammed K Azharuddin, Cathy Williamson, Yee Ping Teoh, Donald C McMillan & Denis St. J. O’Reilly. (2005) Biological Variation of Vitamins in Blood of Healthy Individuals. Clinical Chemistry 51:11, pages 2145-2150.
Crossref
J. C. Libeer & H. M. J. Goldschmidt. (2004) The European Conference on quality in the spotlight in medical laboratories, Antwerp Belgium, 18?19 March 2004. Accreditation and Quality Assurance 10:1-2, pages 1-2.
Crossref
Carmen Ricós, Montserrat García-Victoria & Blanca de la Fuente. (2004) Quality indicators and specifications for the extra-analytical phases in clinical laboratory management. Clinical Chemistry and Laboratory Medicine (CCLM) 42:6.
Crossref
A. Paradiso, S. Volpe, A. Iacobacci, E. Marubini, P. Verderio, A. Costa, M.G. Daidone, A. Marchetti, M. Mottolese, D. Amadori, F. De Paola, L. Saragoni, L. Medri, I. Nenci, P. Querzoli, M. Gion, R. Dittadi, M. Plebani, C. Orlando, G. Bevilacqua & R. Silvestrini. (2018) Quality Control for Biomarker Determination in Oncology: The Experience of the Italian Network for Quality Assessment of Tumor Biomarkers (INQAT). The International Journal of Biological Markers 17:3, pages 201-214.
Crossref
D Robert Dufour, John A Lott, Frederick S Nolte, David R Gretch, Raymond S Koff & Leonard B Seeff. (2000) Diagnosis and Monitoring of Hepatic Injury. I. Performance Characteristics of Laboratory Tests. Clinical Chemistry 46:12, pages 2027-2049.
Crossref
M. Charles Smith, Jingou Liu, Tianling Chen, Horst Schran, Ching-Ming Yeh, François Jamar, Roelf Valkema, Willem Bakker, Larry Kvols, Eric Krenning & Stanislas Pauwels. (2000) OctreoTher<sup>TM</sup>: Ongoing Early Clinical Development of a Somatostatin-Receptor-Targeted Radionuclide Antineoplastic Therapy. Digestion 62:Suppl. 1, pages 69-72.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.