PMID- 37030657 OWN - NLM STAT- MEDLINE DCOM- 20230522 LR - 20230522 IS - 1873-2933 (Electronic) IS - 0009-9120 (Linking) VI - 116 DP - 2023 Jun TI - Comparison of reference intervals for biochemical and hematology markers derived by direct and indirect procedures based on the Isfahan cohort study. PG - 79-86 LID - S0009-9120(23)00073-5 [pii] LID - 10.1016/j.clinbiochem.2023.04.001 [doi] AB - INTRODUCTION: Indirect methods for reference interval (RI) establishment apply statistical techniques to generate RIs for test result interpretation using stored laboratory data. They present unique advantages relative to traditional direct approaches such as fewer resource requirements; however, there is debate regarding their performance. Herein, we aimed to compare indirect and direct approaches for RI establishment by harnessing data from the Isfahan Cohort Study (ICS). This cohort includes both healthy individuals and those with a history of disease, enabling a direct comparison. METHODS: Participants were recruited as part of ICS, including 6504 adults aged 34 years and older. Sociodemographic characteristics, anthropometry, blood pressure, various biochemical indices, and hematology parameters were collected. The refineR method was used to establish indirect RIs (before applying exclusion criteria). Direct RIs were calculated using nonparametric methods per CLSI EP28-A3 guidelines (after applying exclusion criteria). Bias ratios were calculated for each parameter to assess significant differences in estimations. RESULTS: Direct and indirect RI estimations for most hematological and biochemical parameters were comparable. Statistically significant bias ratios between methods were observed for the upper limits of total cholesterol, triglycerides, high-density lipoprotein cholesterol (HDL-C), hemoglobin (female), and platelet count as well as the lower limits of mean corpuscular hemoglobin (female), mean corpuscular volume, hemoglobin, and hematocrit (female). CONCLUSION: Data presented indicate RIs derived from direct and indirect approaches are similar, but not identical. Further work should focus on the clinical significance of such differences as well as the investigation of necessary data-cleaning criteria before indirect method application. CI - Copyright (c) 2023 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved. FAU - Ghazizadeh, Hamideh AU - Ghazizadeh H AD - CALIPER Program, Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada; International UNESCO Center for Health-Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Kathryn Bohn, Mary AU - Kathryn Bohn M AD - CALIPER Program, Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON, Canada. FAU - Esmaily, Habibollah AU - Esmaily H AD - Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran; Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Boskabadi, Mostafa AU - Boskabadi M AD - Department of Biostatistics, School of Health, Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Mohammadi-Bajgiran, Maryam AU - Mohammadi-Bajgiran M AD - International UNESCO Center for Health-Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran. FAU - Farahani, Elina AU - Farahani E AD - CALIPER Program, Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON, Canada. FAU - Boshtam, Maryam AU - Boshtam M AD - Heart Failure Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. FAU - Mohammadifard, Noushin AU - Mohammadifard N AD - Interventional Cardiology Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. FAU - Sarrafzadegan, Nizal AU - Sarrafzadegan N AD - Isfahan Cardiovascular Research Center, Cardiovascular Research Institute, Isfahan University of Medical Sciences, Isfahan, Iran. Electronic address: n.sarrafzadegan@icir.ir. FAU - Adeli, Khosrow AU - Adeli K AD - CALIPER Program, Division of Clinical Biochemistry, Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada; Department of Laboratory Medicine & Pathobiology, University of Toronto, Toronto, ON, Canada. Electronic address: Khosrow.Adeli@sickkids.ca. FAU - Ghayour-Mobarhan, Majid AU - Ghayour-Mobarhan M AD - International UNESCO Center for Health-Related Basic Sciences and Human Nutrition, Mashhad University of Medical Sciences, Mashhad, Iran. Electronic address: ghayourm@mums.ac.ir. LA - eng PT - Journal Article DEP - 20230406 PL - United States TA - Clin Biochem JT - Clinical biochemistry JID - 0133660 RN - 0 (Hemoglobins) RN - 0 (Cholesterol, HDL) SB - IM MH - Adult MH - Humans MH - Female MH - Cohort Studies MH - Reference Values MH - *Hematology MH - Hemoglobins MH - Cholesterol, HDL OTO - NOTNLM OT - CLSI EP28-A3 guidelines OT - Direct and indirect methods OT - Laboratory markers OT - Reference intervals COIS- Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper. EDAT- 2023/04/09 06:00 MHDA- 2023/05/22 06:42 CRDT- 2023/04/08 19:31 PHST- 2022/12/08 00:00 [received] PHST- 2023/04/03 00:00 [revised] PHST- 2023/04/04 00:00 [accepted] PHST- 2023/05/22 06:42 [medline] PHST- 2023/04/09 06:00 [pubmed] PHST- 2023/04/08 19:31 [entrez] AID - S0009-9120(23)00073-5 [pii] AID - 10.1016/j.clinbiochem.2023.04.001 [doi] PST - ppublish SO - Clin Biochem. 2023 Jun;116:79-86. doi: 10.1016/j.clinbiochem.2023.04.001. Epub 2023 Apr 6.