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Verification of harmonized reference intervals in Croatia: is it time for a change?
Iva Friščić1, Ida Burazer1, Andrea Radeljak2
1Department of Medical Biochemistry and Laboratory Medicine, Merkur University Hospital, Zagreb, Croatia.
Biochemia Medica
|June 16, 2026
Summary
Harmonized reference intervals for hematology and coagulation were verified in Croatia. While most clinical chemistry intervals were applicable, international standards offer alternatives when local verification fails.
Area of Science:
- Clinical Laboratory Science
- Biochemistry
- Hematology
Background:
- Harmonized reference intervals (RIs) in Croatia, established in 2004, require re-evaluation due to changes in analytical methods and population demographics.
- This study addresses the need to verify the applicability of current harmonized RIs for key laboratory tests in a Croatian clinical setting.
Purpose of the Study:
- To verify harmonized reference intervals (RIs) for hematology, coagulation, and clinical chemistry laboratory tests.
- To assess the applicability of these verified RIs in a major Croatian clinical hospital center.
Main Methods:
- A verification study was conducted on 100 healthy adults (40 males, 60 females; aged 22-75 years) following CLSI EP28-A3c guidelines.
- Hematology, coagulation, and clinical chemistry analyses were performed using Sysmex, Siemens, Beckman Coulter, and Radiometer analyzers under standardized preanalytical conditions.
- RIs were considered verified if at least 90% of results fell within predefined intervals.
Main Results:
- All tested hematology and coagulation reference intervals (RIs) were successfully verified.
- Out of 27 clinical chemistry analytes, 25 RIs were verified initially; total calcium and alkaline phosphatase required additional verification using international harmonized RIs.
- International harmonized RIs were successfully adopted and verified for total calcium and alkaline phosphatase.
Conclusions:
- The majority of harmonized reference intervals (RIs) currently in use in Croatia are applicable to the adult population within a clinical hospital center.
- Periodic re-evaluation of RIs is crucial due to evolving analytical techniques and population characteristics.
- International harmonized RIs serve as a viable alternative when local verification of specific laboratory tests is unsuccessful.
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