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Paolo Signò, Alessandra Barassi, Raffaele Novario, Gian Vico Melzi d'Eril
Preliminary evaluation of the performance of a new, highly sensitive commercial immunoassay for serum ferritin determination
Keywords: automation, ferritin, turbidimetric immunoassay
We evaluated the analytical performance of a new, commercial, fully automated immunoturbidimetric assay for the determination of ferritin [FER-Latex(X2)CN SEIKEN, Denka Seiken, Japan] in serum on the Olympus AU2700 analyzer. The new assay is a latex-enhanced turbidimetric immunoassay with an analysis time of 10 min. The linearity of the assay was confirmed up to 2505 pmol/L (R 2=0.999). The detection limit and the functional sensitivity were both 4.5 pmol/L. The intra- and inter-assay imprecision (CV) at 67, 506, 2186 pmol/L was <1.8% and <2.5%, respectively. Verification of the traceability to a WHO standard (80/578) showed a recovery of 102.6% (target value 449 pmol/L). No hook effect was observed in samples containing up to 33,705 pmol/L. The assay showed good correlation with the Beckman Immage nephelometric system (r=0.999). Hemoglobin (?9.8 g/L), total bilirubin (?113 ?mol/L), conjugated bilirubin (?109 ?mol/L) and rheumatoid factor (?5.2×10 5 IU/L) did not interfere with the assay. The reference interval (2.5–97.5 percentile) was 72–521pmol/L for men and 27–267 pmol/L for women. The reference interval in patients with anemia, malignant tumors and hemochromatosis was 5.6–52, 130–2436 and 1465–2903 pmol/L, respectively. On the basis of the receiver operating characteristic curve, the 90% sensitivity cut-off value to distinguish between patients with and without iron deficiency was 40 pmol/L. The new latex turbidimetric procedure for ferritin assay is an attractive alternative that avoids the need for dedicated instrumentation.
Clinical Chemical Laboratory Medicine, Walter de Gruyter
Print ISSN: 1434-6621
Volume: 43, 08/2005
Pages: 883 - 885