Md Nahidul Islam1,2,3, Tomás P Griffin2,4, Robert Whiriskey4, Siobhan Hamon1, Brendan Cleary5, Liam Blake1, Damian G Griffin1, Matthew D Griffin2,6, Janusz Krawczyk5, Paula M O'Shea7. 1. Department of Clinical Biochemistry, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Newcastle Road, Galway, Ireland. 2. Regenerative Medicine Institute At CÚRAM SFI Research Centre, School of Medicine, National University of Ireland Galway (NUIG), Galway, Ireland. 3. Discipline of Biochemistry, School of Natural Sciences, National University of Ireland Galway (NUIG), Galway, Ireland. 4. Centre for Endocrinology, Diabetes and Metabolism, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland. 5. Department of Haematology, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland. 6. Department of Nephrology, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Galway, Ireland. 7. Department of Clinical Biochemistry, Saolta University Health Care Group (SUHCG), Galway University Hospitals, Newcastle Road, Galway, Ireland. PaulaM.OShea@hse.ie.
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.
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.
Authors: Sarah M Moran; Jennifer Scott; Michael R Clarkson; Niall Conlon; Jean Dunne; Matthew D Griffin; Tomas P Griffin; Elizabeth Groarke; John Holian; Conor Judge; Jason Wyse; Kirsty McLoughlin; Paul V O'Hara; Mark A Little; Matthias Kretzler Journal: J Am Soc Nephrol Date: 2021-09-13 Impact factor: 10.121