| Popis: |
Background Serum ferritin is considered a suitable biomarker of iron-related disorders. However, data about the comparability of results among commercial measuring systems (MSs) are contradictory. We performed an intercomparison study aimed at verifying the current interassay variability and its impact on clinical application of the test. Obtaining this information is vital because manufacturers continue to claim calibration alignment to different WHO preparations, which are not related to each other in terms of traceability. Methods Four widely used MSs were evaluated. The interassay agreement was verified using 39 human serum pools. The recovery of WHO International Standard (IS) 94/572 (the only reference material available at the time of the study) was evaluated, after assessing the material commutability. Finally, an approach for harmonizing ferritin results was proposed. Results Highly significant differences (P Conclusions The harmonization among evaluated ferritin MSs is far from optimal, with the implementation of traceability to different WHO ISs being a factor of confusion. A recalibration approach, however, would permit measurement harmonization, allowing the use of common decision thresholds. |
