Literature DB >> 17909615

The Joint Committee for Traceability in Laboratory Medicine (JCTLM): a global approach to promote the standardisation of clinical laboratory test results.

David Armbruster1, Richard R Miller.   

Abstract

Clinical laboratories are moving towards global standardisation to produce equivalent test results across space and time. Standardisation allows use of evidence-based medicine, eliminates the need of method-specific reference intervals, decision levels and cut-offs, and can be achieved by application of metrological principles. For example, in vitro diagnostics (IVD) manufacturers can make kit calibrators traceable to internationally recognised reference materials and reference methods. The first step towards standardisation is to identify appropriate reference materials and methods. This has been undertaken by a new international consortium, the Joint Committee for Traceability in Laboratory Medicine (JCTLM), formed in 2002. It brings together experts representing the clinical laboratory profession, government agencies, and manufacturers, to promote international comparability, reliability, and equivalence of measurement results in clinical laboratories for the purpose of improving healthcare. Through the efforts of the JCTLM, manufacturers are able to assign values to kit calibrators with consistency using appropriate higher order reference materials and methods, and traceability flowcharts, according to ISO Standards to ensure accuracy of test results and to promote assay performance harmonisation. Users of assay kits can assess suitability of calibrators on the basis of acceptable reference materials and/or methods identified by the JCTLM. The JCTLM exemplifies the dynamic nature of clinical laboratory medicine, the inherent spirit of cooperation among professionals in this scientific field, and the international desire to strive for the highest level of clinical laboratory practice for the benefit of patients.

Entities:  

Year:  2007        PMID: 17909615      PMCID: PMC1994110     

Source DB:  PubMed          Journal:  Clin Biochem Rev        ISSN: 0159-8090


  8 in total

1.  Immunoassay standardization: is it possible, who is responsible, who is capable?

Authors:  U H Stenman
Journal:  Clin Chem       Date:  2001-05       Impact factor: 8.327

2.  Target values and method evaluation in proficiency testing programs.

Authors:  R Rej; C S Norton-Wenzel; Z Cao
Journal:  Clin Chem       Date:  2001-12       Impact factor: 8.327

3.  Quality specifications for cardiac troponin assays.

Authors:  M Panteghini; W Gerhardt; F S Apple; F Dati; J Ravkilde; A H Wu
Journal:  Clin Chem Lab Med       Date:  2001-02       Impact factor: 3.694

Review 4.  Standardization of cardiac markers.

Authors:  Fred S Apple
Journal:  Scand J Clin Lab Invest Suppl       Date:  2005

5.  What information should manufacturers provide on their procedures?

Authors:  Renze Bais
Journal:  Clin Chem       Date:  2006-08       Impact factor: 8.327

6.  Quality specifications for B-type natriuretic peptide assays.

Authors:  Fred S Apple; Mauro Panteghini; Jan Ravkilde; Johannes Mair; Alan H B Wu; Jillian Tate; Franca Pagani; Robert H Christenson; Allan S Jaffe
Journal:  Clin Chem       Date:  2005-03       Impact factor: 8.327

7.  Toward standardization of cardiac troponin I measurements part II: assessing commutability of candidate reference materials and harmonization of cardiac troponin I assays.

Authors:  Robert H Christenson; Show Hong Duh; Fred S Apple; Geza S Bodor; David M Bunk; Mauro Panteghini; Michael J Welch; Alan H B Wu; Stephen E Kahn
Journal:  Clin Chem       Date:  2006-07-20       Impact factor: 8.327

8.  Variation in prostate specific antigen results from 2 different assay platforms: clinical impact on 2304 patients undergoing prostate cancer screening.

Authors:  Richard E Link; Shahrokh F Shariat; Cuong V Nguyen; Anita Farr; Armin D Weinberg; Ronald A Morton; Barbara Richardson; David Bernard; Kevin M Slawin
Journal:  J Urol       Date:  2004-06       Impact factor: 7.450

  8 in total
  17 in total

Review 1.  International standards and reference materials for quantitative molecular infectious disease testing.

Authors:  Roberta M Madej; Jack Davis; Marcia J Holden; Stan Kwang; Emmanuel Labourier; George J Schneider
Journal:  J Mol Diagn       Date:  2010-01-14       Impact factor: 5.568

Review 2.  Fat-Soluble Vitamins: Clinical Indications and Current Challenges for Chromatographic Measurement.

Authors:  Ali A Albahrani; Ronda F Greaves
Journal:  Clin Biochem Rev       Date:  2016-02

Review 3.  Standardization of Nucleic Acid Tests for Clinical Measurements of Bacteria and Viruses.

Authors:  Jernej Pavšič; Alison S Devonshire; Helen Parkes; Heinz Schimmel; Carole A Foy; Maria Karczmarczyk; Ion Gutiérrez-Aguirre; Isobella Honeyborne; Jim F Huggett; Timothy D McHugh; Mojca Milavec; Heinz Zeichhardt; Jana Žel
Journal:  J Clin Microbiol       Date:  2014-11-12       Impact factor: 5.948

4.  A guide to harmonisation and standardisation of measurands determined by liquid chromatography - tandem mass spectrometry in routine clinical biochemistry.

Authors:  Ronda F Greaves
Journal:  Clin Biochem Rev       Date:  2012-11

5.  Laboratory medicine best practice guideline: vitamins a, e and the carotenoids in blood.

Authors:  Ronda F Greaves; Gerald A Woollard; Kirsten E Hoad; Trevor A Walmsley; Lambro A Johnson; Scott Briscoe; Sabrina Koetsier; Tamantha Harrower; Janice P Gill
Journal:  Clin Biochem Rev       Date:  2014-05

6.  Recommendations for the Generation, Quantification, Storage, and Handling of Peptides Used for Mass Spectrometry-Based Assays.

Authors:  Andrew N Hoofnagle; Jeffrey R Whiteaker; Steven A Carr; Eric Kuhn; Tao Liu; Sam A Massoni; Stefani N Thomas; R Reid Townsend; Lisa J Zimmerman; Emily Boja; Jing Chen; Daniel L Crimmins; Sherri R Davies; Yuqian Gao; Tara R Hiltke; Karen A Ketchum; Christopher R Kinsinger; Mehdi Mesri; Matthew R Meyer; Wei-Jun Qian; Regine M Schoenherr; Mitchell G Scott; Tujin Shi; Gordon R Whiteley; John A Wrobel; Chaochao Wu; Brad L Ackermann; Ruedi Aebersold; David R Barnidge; David M Bunk; Nigel Clarke; Jordan B Fishman; Russ P Grant; Ulrike Kusebauch; Mark M Kushnir; Mark S Lowenthal; Robert L Moritz; Hendrik Neubert; Scott D Patterson; Alan L Rockwood; John Rogers; Ravinder J Singh; Jennifer E Van Eyk; Steven H Wong; Shucha Zhang; Daniel W Chan; Xian Chen; Matthew J Ellis; Daniel C Liebler; Karin D Rodland; Henry Rodriguez; Richard D Smith; Zhen Zhang; Hui Zhang; Amanda G Paulovich
Journal:  Clin Chem       Date:  2016-01       Impact factor: 8.327

7.  Standardization, Harmonization, and Realization.

Authors:  Nicole L Gentile; Richard F Louie; Jorge Sifontes; Daniel Mecozzi; Kristin Hale; Gerald J Kost
Journal:  Point Care       Date:  2008-09-01

Review 8.  Enabling consistency in pluripotent stem cell-derived products for research and development and clinical applications through material standards.

Authors:  Anna French; Christopher Bravery; James Smith; Amit Chandra; Peter Archibald; Joseph D Gold; Natalie Artzi; Hae-Won Kim; Richard W Barker; Alexander Meissner; Joseph C Wu; Jonathan C Knowles; David Williams; Guillermo García-Cardeña; Doug Sipp; Steve Oh; Jeanne F Loring; Mahendra S Rao; Brock Reeve; Ivan Wall; Andrew J Carr; Kim Bure; Glyn Stacey; Jeffrey M Karp; Evan Y Snyder; David A Brindley
Journal:  Stem Cells Transl Med       Date:  2015-02-03       Impact factor: 6.940

9.  Wearable sensors enable personalized predictions of clinical laboratory measurements.

Authors:  Jessilyn Dunn; Lukasz Kidzinski; Ryan Runge; Daniel Witt; Jennifer L Hicks; Sophia Miryam Schüssler-Fiorenza Rose; Xiao Li; Amir Bahmani; Scott L Delp; Trevor Hastie; Michael P Snyder
Journal:  Nat Med       Date:  2021-05-24       Impact factor: 53.440

10.  Lessons from the NIST micronutrients quality assurance program for vitamin C, 1993 to 2015: sample stability, assay reproducibility, and use of controls to improve comparability.

Authors:  David L Duewer; Jeanice Brown Thomas; Katherine E Sharpless; Sam A Margolis
Journal:  Anal Bioanal Chem       Date:  2020-11-02       Impact factor: 4.142

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