Journal Information
Journal ID (publisher-id): BM
Journal ID (nlm-ta): Biochem Med (Zagreb)
Title: Biochemia Medica
Abbreviated Title: Biochem. Med. (Zagreb)
ISSN (print): 1330-0962
ISSN (electronic): 1846-7482
Publisher: Croatian Society of Medical Biochemistry and Laboratory Medicine
Article Information
Copyright statement: Copyright Croatian Society of Medical Biochemistry and Laboratory Medicine
Copyright: 2024, Copyright Croatian Society of Medical Biochemistry and Laboratory Medicine
License (https://creativecommons.org/licenses/by/4.0/):
This is an open-access article distributed under the terms of the Creative Commons Attribution (CC BY) 4.0 License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Date received: 06 December 2023
Date accepted: 28 February 2024
Publication date: 15 April 2024
Publication date: 15 June 2024
Volume: 34
Issue: 2
Electronic Location Identifier: 020705
Publisher ID: bm-34-2-020705
DOI: 10.11613/BM.2024.020705
CLSI-based verification and de novo establishment of reference intervals for common biochemical assays in Croatian newborns
Sonja Perkov[1]
Andrea Radeljak[1]
Jasminka Stipanović-Kastelić[2]
Mirjana Mariana Kardum Paro[1]
Author notes:
[*] Corresponding author: iva.friscic@gmail.com
Authorship contributions
IF: Conceptualization, Data duration, Formal analysis, Investigation, Supervision, Writing - original draft. SP: Conceptualization, Investigation, Resources, Writing - review & editing. AR: Conceptualization, Investigation; JSK: Resources. MMKP: Conceptualization, Resources, Writing - review & editing.
• Referent persons were selected using the direct a posteriori sampling method
• Nineteen most commonly used biochemical assays on Beckman Coulter AU680
• Harmonized reference intervals are suitable for most assays
• De novo reference intervals for potassium, magnesium and direct bilirubin were determined
Introduction
This study aimed to examine whether the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) reference intervals for 19 commonly used biochemical assays (potassium, sodium, chloride, calcium, magnesium, inorganic phosphorous, glucose, urea, creatinine, direct and total bilirubin, C-reactive protein (CRP), total protein, albumin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), alkaline phosphatase (ALP) and lactate dehydrogenase (LD)) could be applied to the newborn population of one Croatian clinical hospital.
Materials and methods
Reference interval verification was performed according to the CLSI EP28-A3c guidelines. Samples of healthy newborns were selected using the direct a posteriori sampling method and analyzed on the Beckman Coulter AU680 biochemical analyzer. If verification wasn’t satisfactory, further procedure included de novo determination of own reference intervals by analyzing 120 samples of healthy newborns.
Results
After the first set of measurements, 14/19 tested reference intervals were adopted for use: calcium, inorganic phosphorous, glucose, urea, creatinine, total bilirubin, CRP, total protein, albumin, AST, ALT, GGT, ALP and LD. A second set of samples was tested for 5 analytes: potassium, sodium, chloride, magnesium and direct bilirubin. The verification results of the additional samples for sodium and chloride were satisfactory, while the results for potassium, magnesium and direct bilirubin remained unsatisfactory and new reference intervals were determined.
Keywords: reference values; reference range; neonatology; pediatrics; biochemistry