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Title: Assessment of analytical bias in ferritin assays and impact on functional reference limits.
Authors: Choy, Kay Weng
Sezgin, Gorkem
Wijeratne, Nilika
Calleja, John
Liwayan, Rachelle
Rathnayake, Geetha
McFarlane, Robert
McNeil, Alan
Doery, James C G
Lu, Zhong
Markus, Corey
Loh, Tze Ping
Citation: Copyright © 2021 Royal College of Pathologists of Australasia. Published by Elsevier B.V. All rights reserved.
Pathology. 2021 Sep 15:S0031-3025(21)00434-7. doi: 10.1016/j.pathol.2021.06.123.
Abstract: Serum ferritin is currently the recommended laboratory test to investigate iron deficiency. There have been efforts to standardise serum ferritin assays with implementation of traceability to the World Health Organization reference standard. We evaluate the analytical bias among five widely used commercial ferritin assays in Australia. The relationship between serum ferritin and erythrocyte parameters was recently explored to derive functional reference limits. Residual patient serum specimens were analysed by five participating laboratories that utilised a different ferritin assay, Abbott, Beckman Coulter, Roche, Siemens, and Ortho. Using data mining approach, functional reference limits for Siemens, Abbott, and Ortho serum ferritin methods were derived and compared. At clinically relevant ferritin decision points, compared to the Beckman method, the Roche assay showed higher results ranging from 6 μg/L (31%) at the lowest decision point to 575 μg/L (57%) at the highest decision point. In contrast, the Ortho method underestimated ferritin results at lower decision points of 20 and 30 μg/L, with estimated ferritin results of 16 μg/L (-19%) and 27 μg/L (-12%), respectively. The Abbott and Siemens assays showed a positive bias which was introduced at differing decision points. The comparison of the Siemens and Ortho methods presents similar inflection points between the two assays in the establishment of functional reference limits for serum ferritin. There remain significant biases among some of the commonly used commercial ferritin assays in Australia. More studies are needed to assess if functional reference limits are a way to overcome method commutability issues.
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Journal title: Pathology
Publication Date: 2021-09-15
Type: Journal Article
DOI: 10.1016/j.pathol.2021.06.123
Appears in Collections:(a) NT Health Research Collection

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