Hemolysis index. Can we uncritically trust manufacturer declarations?
Alen Vrtaric1,2, Marijana Miler1,2, Nora Nikolac Gabaj1,2,3
1Working Group for Preanalytical Phase of the Croatian Society of Medical Biochemistry and Laboratory Medicine, Zagreb, Croatia.
Clinical Chemistry and Laboratory Medicine
|October 23, 2025
Summary
Manufacturer hemolysis interference data is inconsistent and often lacks crucial details. Clinical labs must validate these thresholds independently to ensure accurate patient results and maintain quality standards.
Area of Science:
- Clinical Biochemistry
- Preanalytical Variables
- Laboratory Medicine
Background:
- Hemolysis is a frequent preanalytical interference in clinical biochemistry, impacting up to 3.3% of samples and causing ~60% of specimen rejections.
- This interference arises from the release of intracellular components like hemoglobin and potassium due to red blood cell membrane damage.
- Current hemolysis index (HI) thresholds from in vitro diagnostic (IVD) analyzers may not align with clinical needs or biological variability.
Purpose of the Study:
- To evaluate the consistency and completeness of hemolysis interference data provided by major IVD manufacturers.
- To compare manufacturer data against the Clinical and Laboratory Standards Institute (CLSI) C56-A guideline.
- To identify discrepancies in hemolysis interference reporting and validation criteria.
Main Methods:
- A descriptive study analyzed hemolysis interference data for 72 clinical chemistry analytes from five manufacturers (Abbott, Beckman Coulter, BioSystems, Roche, Siemens).
- Manufacturer package inserts were reviewed and compared with the CLSI C56-A guideline.
- Data points included reported analyte levels, interference criteria, and bias values.
Main Results:
- Manufacturer compliance with the CLSI guideline varied significantly; Siemens showed higher compliance than others.
- BioSystems provided no analyte concentrations for tested parameters.
- Inconsistent reporting of interference criteria, arbitrary bias thresholds (e.g., 10%), and missing bias data were common across manufacturers, with only Abbott and Siemens offering detailed bias information.
Conclusions:
- Manufacturer instructions for hemolysis interference are frequently incomplete and inconsistent.
- Clinical laboratories must independently validate hemolysis thresholds to ensure accuracy and reliability.
- A harmonized approach combining manufacturer data, research, and local validation is essential for improving laboratory quality and regulatory compliance.
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