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Enhancing the accuracy of measurement of small molecule organic biomarkers

Abstract

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.

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Abbreviations

BIPM:

International Bureau of Weights and Measures

CCQM:

Consultative Committee for Amount of Substance: Metrology in Chemistry and Biology

CIPM:

International Committee for Weights and Measures

CRM:

certified reference material

DBS:

Dried Blood Spot

DEQAS:

Vitamin D External Quality Assessment Scheme

DI:

Designated Institute

EQALM:

External Quality Assurance Programmes in Laboratory Medicine

EURAMET:

European Association of National Metrology Institutes

EQAS:

External Quality Assessment Schemes

ICHCLR:

International Consortium for Harmonization of Clinical Laboratory Results

IDMS:

Isotope dilution-mass spectrometry

IMEP:

International Measurement Evaluation Programme

IFCC:

International Federation for Clinical Chemistry and Laboratory Medicine

ILAC:

International Laboratory Accreditation Cooperation

ISO:

International Organization for Standardization

IVD:

In-vitro diagnostic

JCTLM:

Joint Committee for Traceability in Laboratory Medicine

MRA:

Mutual Recognition Arrangement

NMI:

National Metrology Institute

OAWG:

Organic Analysis Working Group

RMPs:

Reference measurement procedures

SI:

International System of Units

PT:

Proficiency testing

RCPAQAP:

Royal Australasian College of Pathologists Quality Assurance Programs

SRM:

Standard Reference Material®

VDSP:

Vitamin D Standardization Program

VitDQAP:

Vitamin D Metabolites Quality Assurance Program

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Acknowledgments

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.

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Correspondence to Tang Lin Teo.

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Teo, T.L., Lippa, K.A., Mackay, L. et al. Enhancing the accuracy of measurement of small molecule organic biomarkers. Anal Bioanal Chem 411, 7341–7355 (2019). https://doi.org/10.1007/s00216-019-02153-x

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Keywords

  • Biomarker
  • Clinical measurements
  • Metrological traceability
  • Certified reference materials (CRMs)
  • Pilot studies and key comparisons
  • External quality assessment schemes (EQAS)