A-085 Clinical Consequences of lack of Standardization/Harmonization of Ferritin Assays

Abstract Background The lack of standardization and harmonization among ferritin assays results in significant variability in clinical values. These assays have different reference ranges and numerous clinical cut-offs for interpreting anemia and iron toxicity. This inconsistency is due to manufacturers using various calibrators. Such variability complicates the interpretation and comparison of results across different clinical settings. Methods Ferritin was ordered for 7815 patient samples in 3 months and assays were performed by DXI. Similarly, 5818 patients’ samples were run by Roche in two months. Both assays are FDA cleared and are commonly used by hundreds of clinical laboratories. Frequency of no of patients flagged low or flagged were calculated with respective reference ranges of Dxi and Cobas. Results 12 percent of the patients were flagged low by the Beckman assay and would have gotten both physician and patients attention. However, by the Roche assay only 4 percent were flagged low. This was alarming to our physicians and lab was told to investigate to find for this shift. Manufacturer/Time Range Total Volume Total High Total Low %High %Low Dxi-May-24 2617 368 326 14.1% 12% Dxi-Jun-24 2391 345 278 14% 12% Dxi-Jul-24 2807 500 308 17.8% 11% Cobas-801 August 2024 - Ferritin Go Live Cobas-801-Sep-24 2545 572 105 22% 4% Cobas-801-Oct-24 2841 695 121 24% 4% Conclusion Lack of Standardization and harmonization has serious consequences for the patients being tested for ferritin to diagnose deficiency of iron or high iron situations. We are planning to do a prospective study to determine clinical cut-offs by correlating Ferritin lab results with other gold standard biomarkers including bone marrow biopsy.