The accuracy and clinical interpretation of serum ferritin assays

The accuracy of methods used to assay serum ferritin was determined in two ways. In one a serum, to which the UK ferritin standard had been added, was issued to the participants in an inter-regional quality assurance scheme. The overall recovery was close to that expected. For the second assessment a series of sera from individuals of known iron status were issued. Differences between assay results related to the method of assay though the immunoradiometric and ELISA methods gave results which were close to each other. The variation in clinical interpretation applied to assay results when ferritin concentrations around the upper and lower limits of normal were assayed was more than could be accounted for by method imprecision and indicates that inappropriate reference ranges are in common use. 'Indeterminate', a proper clinical interpretation when the imprecision of a technique should prevent a definite response, was inadequately used.