Establishment of Reference Range of Serum Ferritin by Turbidimetric Immunoassay in Korean First Time Blood Donors

Oh, Deok Ja; Lee, Ja Young; Seo, Mu Won

Abstract

BACKGROUND
Regular blood donation can lead to iron deficiency. Serum ferritin is sensitive indicator of body iron depletion. The aim of this study is to evaluate serum ferritin reagents using the turbidimetric immunoassay (TIA) and to establish a reference range in first time blood donors in Korea.
METHODS
The study was prospectively conducted, between Feb. 2011 and Apr. 2011, on 120 male and 120 female blood donors at five blood centers. Serum ferritin was determined by TIA using two brands of reagents (Beckman Coulter Inc., USA; HBi, South Korea) and two automated chemistry analyzers (AU640, Beckman Coulter Inc.; Hitachi7180, Hitachi High-Technologies Corp., Japan). Precision, linearity, limit of detection, analytical measurement range and correlation with chemiluminescent immunoassay (CLIA) were evaluated. A reference range for serum ferritin in first time donors was established.
RESULTS
The coefficients of variation of precision were less than 4%. Linearity was observed up to 312.7~450 microg/L depending on which reagent used. Both reagents had good correlation with CLIA results. Serum ferritin levels for first time donors showed left skewed distribution. The reference ranges for males and females were 34.1~385.9 microg/L and 6.8~121 microg/L using Beckman Coulter (AU) reagent, and 18.7~271.3 microg/L and 4~83.7 microg/L using HBi (AU) reagent, and 15.2~274.7 microg/L and 6~84 microg/L using HBi (Hitachi) reagent.
CONCLUSION
A reference range for serum ferritin in first time donors in Korea was established using automated chemistry analyzers with inexpensive TIA reagents.