Lab Med Qual Assur 2022; 44(2): 111-120
Published online June 30, 2022
Copyright © Korean Association of External Quality Assessment Service.
1Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, Hwaseong; 2Department of Laboratory Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul; 3Department of Laboratory Medicine, International St. Mary’s Hospital, Catholic Kwandong University College of Medicine, Incheon; 4Department of Laboratory Medicine, Green Cross Laboratories, Yongin; 5Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Korea
Correspondence to:Eun-jung Cho
Department of Laboratory Medicine, Hallym University Dongtan Sacred Heart Hospital, Hallym University College of Medicine, 7 Keunjaebong-gil, Hwaseong 18450, Korea
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: Commutability is essential to harmonize different measuring systems and to evaluate the performance of participating laboratories in external quality assessment (EQA). This study aims to assess the commutability of EQA materials in the tumor marker program of the Korean Association of External Quality Assessment Service.
Methods: We analyzed commercial quality control (QC) materials, individual patient samples, and frozen human serum pools (FSPs) based on the Clinical and Laboratory Standards Institute guidelines. Alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and total prostate-specific antigen (PSA) were assayed in triplicate in all samples using four analytical systems at the three laboratories. The results obtained from pairs of assays were plotted and assessed using Deming regression analysis. The criterion for commutability was a 95% prediction interval, and bias for noncommutability was calculated.
Results: FSPs were commutable in all AFP, CEA, and total PSA assay methods. Bias for AFP, CEA, and total PSA ranged from –203% to 27%, –67% to 45%, and –9% to 12%, respectively. Commercial QC materials for AFP and PSA were commutable in four assays, whereas for CEA, noncommutability was observed.
Conclusions: Our results validated that the frozen serum pools were commutable across different platforms for tumor marker assays. Therefore, validation findings from materials like FSPs and information about their commutability needs to be reported, for the applicability of EQA programs.
Keywords: Commutability, External quality assessment, Frozen human serum pools, Immunoassay, Tumor biomarkers
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