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Reference intervals for commonly requested biochemical and haematological parameters in a healthy Irish adult Caucasian population

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Abstract

Introduction

In laboratory medicine, reference intervals (RIs) are key decision support tools used to guide the clinical interpretation of numerical test results. Best practice suggests each laboratory establishes RIs in the local population prior to introducing an assay into routine clinical practice.

Aim

The aim of this study was to define RIs for frequently requested biochemical/haematological parameters in a healthy adult Irish Caucasian population.

Methods

A cross-sectional study of non-pregnant apparently healthy volunteers was conducted. Baseline demographics, anthropometric and laboratory measurements were recorded. In total, 37 commonly requested biochemical (serum, n = 26) and haematological (venous blood, n = 11) ISO15189:2012 accredited tests were analysed, using the Roche Cobas® Sebia Capillarys 3 Tera and Siemens Advia® 2120i platforms following standard operating procedures. RIs were defined according to the International Federation of Clinical Chemistry (IFCC) recommended method.

Results

Of 208 apparently healthy volunteers, 76 failed to meet the study inclusion criteria. The reference population comprised of 132 participants (males: n = 65, 49.2%) with a median age of 29.7 (18.1–62.2) years. RIs for the majority of biochemical/haematological parameters were broadly in accord with those provided by Pathology Harmony (UK)/Irish RI Harmonisation Project and the manufacturer Roche Diagnostics. However, the established RI defined for HbA1c: 27–37 mmol/mol was markedly different from that quoted nationally, HbA1c: 20–42 mmol/mol.

Conclusion

Normative biological intervals established in a healthy adult Irish population for 37 commonly requested biochemical/haematological parameters will be a valuable aid to result interpretation in clinical laboratories after appropriate verification in accordance with ISO 15189: 2012.

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Acknowledgements

We wish to express our gratitude to all volunteers who made this study possible. Special thanks to the scientific, nursing and medical staff at the Centre for Endocrinology, Diabetes and Metabolism and the Departments of Clinical Biochemistry and Haematology at Saolta University Health Care Group (SUHCG), University Hospital Galway.

Funding

TPG is supported by a Hardiman Scholarship from the College of Medicine, Nursing and Health Science, National University of Ireland, Galway, and a bursary from the Irish Endocrine Society/Royal College of Physicians of Ireland. The authors are supported by grants from the European Commission: Horizon 2020 Collaborative Health Project NEPHSTROM (grant number 634086; TPG, NI, MDG), FP7 Collaborative Health Project VISICORT (grant number 602470; MDG), Science Foundation Ireland: REMEDI Strategic Research Cluster (grant number 09/SRC-B1794; MDG), CÚRAM Research Centre (grant number 13/RC/2073; MDG) and by the European Regional Development Fund.

Author information

Author notes

  1. Md Nahidul Islam and Tomás P. Griffin contributed equally to this work

Authors and Affiliations

  1. Department of Clinical Biochemistry, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Newcastle Road, Galway, Ireland

    Md Nahidul Islam, Siobhan Hamon, Liam Blake, Damian G. Griffin & Paula M. O’Shea

  2. Regenerative Medicine Institute At CÚRAM SFI Research Centre, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland

    Md Nahidul Islam, Tomás P. Griffin & Matthew D. Griffin

  3. Discipline of Biochemistry, School of Natural Sciences, National University of Ireland Galway (NUIG), Galway, Ireland

    Md Nahidul Islam

  4. Centre for Endocrinology, Diabetes and Metabolism, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland

    Tomás P. Griffin & Robert Whiriskey

  5. Department of Nephrology, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland

    Matthew D. Griffin

  6. Department of Haematology, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland

    Brendan Cleary & Janusz Krawczyk

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Contributions

MNI: Recruitment, consenting and pre-testing preparation of participants, sample collection and processing, data acquisition, assembly, analysis and interpretation; TPG: medical assessment, recruitment, consenting and pre-testing preparation of participants, sample collection and processing, data acquisition and assembly; RW: Recruitment, consenting, and pre-testing preparation of participants and sample collection; SH: sample processing and analytical analyses; LB: quality and accuracy of laboratory methods; DGG: quality and accuracy of laboratory methods and interpretation; MDG: study design, data analysis and interpretation; BC: analytical analyses, quality and accuracy of laboratory methods; JK: quality and accuracy of laboratory methods and interpretation PMOS: conception, study design, quality and accuracy of laboratory methods, data acquisition, assembly, statistical analysis and interpretation. MNI: first draft of manuscript. All authors reviewed, edited and approved the final version of the manuscript.

Corresponding author

Correspondence to Paula M. O’Shea.

Ethics declarations

Ethical approval

Ethical approval was granted by the Clinical Research Ethics Committee, Galway University Hospitals (Ref: C.A. 1404) and the National University of Ireland, Galway Research Ethics Committee (Ref: 16-July-05).

Competing interests

The authors declare that they have no conflict of interest.

Supplementary Information

Below is the link to the electronic supplementary material.

11845_2021_2535_MOESM1_ESM.doc

Supplementary file1: Supplemental Table 1: Analytical Performance Specifications of the biochemical/haematological parameters (DOC 267 KB)

11845_2021_2535_MOESM2_ESM.docx

Supplementary file2: Supplemental Table 2: Established reference intervals in Irish adults for commonly requested biochemical tests compared to those provided by Roche Cobas® (DOCX 20 KB)

Supplementary file3:: Supplemental Figure 1: Health Questionnaire (DOCX 22 KB)

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Islam, M.N., Griffin, T.P., Whiriskey, R. et al. Reference intervals for commonly requested biochemical and haematological parameters in a healthy Irish adult Caucasian population. Ir J Med Sci 191, 301–311 (2022). https://doi.org/10.1007/s11845-021-02535-0

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  • DOI: https://doi.org/10.1007/s11845-021-02535-0

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