Enhancing the accuracy of measurement of small molecule organic biomarkers
Over two decades, the Organic Analysis Working Group (OAWG) of the Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology (CCQM) has organized a number of comparisons for clinically relevant small molecule organic biomarkers. The aim of the OAWG community is to be part of the coordinated international movement towards accuracy and comparability of clinical measurements that will, in turn, minimize the wastage of repeat testing and unnecessary therapy to create a sustainable healthcare industry. International and regional directives/requirements on metrological traceability of calibrators and control materials are in place. Metrology institutes worldwide maintain infrastructure for the practical realization of metrological traceability and demonstrate the equivalence of their measurement capabilities through participation in key comparisons organized under the auspices of the CCQM. These institutes provide certified reference materials, as well as other dedicated value-assignment services benefiting the in-vitro diagnostic (IVD) industry, reference (calibration) laboratories and the clinical chemistry laboratories. The roles of these services in supporting national, regional, and international activities to ensure the metrological traceability of clinical chemistry measurements are described.
KeywordsBiomarker Clinical measurements Metrological traceability Certified reference materials (CRMs) Pilot studies and key comparisons External quality assessment schemes (EQAS)
International Bureau of Weights and Measures
Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology
International Committee for Weights and Measures
certified reference material
Dried Blood Spot
Vitamin D External Quality Assessment Scheme
External Quality Assurance Programmes in Laboratory Medicine
European Association of National Metrology Institutes
External Quality Assessment Schemes
International Consortium for Harmonization of Clinical Laboratory Results
Isotope dilution-mass spectrometry
International Measurement Evaluation Programme
International Federation for Clinical Chemistry and Laboratory Medicine
International Laboratory Accreditation Cooperation
International Organization for Standardization
Joint Committee for Traceability in Laboratory Medicine
Mutual Recognition Arrangement
National Metrology Institute
Organic Analysis Working Group
Reference measurement procedures
International System of Units
Royal Australasian College of Pathologists Quality Assurance Programs
Standard Reference Material®
Vitamin D Standardization Program
Vitamin D Metabolites Quality Assurance Program
The authors thank all colleagues involved in the organization and participation of the CCQM pilot studies and key comparisons for small molecule organic biomarkers over the past two decades. HSA acknowledges the contributions by Lingkai Wong, Yizhao Chen, Hong Liu, and Hui Ling Teo. NIST acknowledges the contributions by Lorna Sniegoski, Michael J. Welch, Susan S.-C. Tai, Jeanita Pritchett, Karen W. Phinney and David L. Duewer, as well as Steven A. Wise and Christopher T. Sempos in collaboration with and financial support from the NIH Office of Dietary Supplements. NMIA acknowledges the contributions by Stephen Davies, Veronica Vamathevan, Mark Lewin, Lesley Johnston, Meg Croft, and Edwin J Murby. LNE acknowledges the contributions by Catherine Perrot, Maryline Peignaux, Carine Fallot, Julie Cabillic, and Gustavo Martos. KRISS acknowledges the contributions by Byungjoo Kim, Inchul Yang, Dukjin Kang, and Hwashim Lee. NIMT acknowledges the contributions by Cheerapa Boonyakong, Charun Yafa, and the Thailand Creatinine Standardization Working Group. INMETRO acknowledges the contributions by Bruno C. Garrido, Eliane C.P. Rego and Jane L. N. Fernandes.
Compliance with ethical standards
Conflict of interest
The authors declare no conflict of interest.
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