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Performance evaluation and characterization of pre-analytical effects by sample types and storage conditions on tumor marker measurement by the point-of-care test platform IchromaTM II

Authors
 Sojin Lee  ;  Jaehyeok Jang  ;  Hanmil Jang  ;  Hyein Kang  ;  John Hoon Rim  ;  Jong-Baeck Lim 
Citation
 CLINICA CHIMICA ACTA, Vol.563 : 119902, 2024-09 
Journal Title
CLINICA CHIMICA ACTA
ISSN
 0009-8981 
Issue Date
2024-09
MeSH
Biomarkers, Tumor* / blood ; Carcinoembryonic Antigen / analysis ; Carcinoembryonic Antigen / blood ; Humans ; Point-of-Care Systems / standards ; Pre-Analytical Phase ; Prostate-Specific Antigen / analysis ; Prostate-Specific Antigen / blood ; Specimen Handling ; alpha-Fetoproteins / analysis
Keywords
Biospecimen ; Point-of-care test ; Pre-analytical factor ; Stability ; Tumor marker
Abstract
Tumor markers should be measured regularly and accurately to prevent, diagnose, and monitor cancers efficiently. We aimed to characterize the pre-analytical factors effecting on the analytical performance of point-of-care test (POCT) platform IchromaTM II (Boditech Med Inc., Gangwon-do, Korea) for alpha-fetoprotein (AFP), carcinoembryonic antigen (CEA), and prostate specific antigen (PSA) and evaluate their consequences in clinical practice. Based on comprehensive evaluation for the analytical performance of IchromaTM II including precision, linearity, and method comparison performed according to CLSI guidelines, pre-analytical factors of sample types and conditions were extensively analyzed. A total of five sample types [serum, plasma (PL) and whole blood (WB) from EDTA tube, PL and WB from sodium heparin tube] from 40 patients were used for comparing among specimen types. Additionally, stability was assessed up to 21 h at room temperature, refrigerated for 8 days, and frozen for 16 weeks by using 4 levels of pooled patient samples which were measured in triplicate. Precision, linearity and correlation with central laboratory analyzers observed in all three tumor markers were within acceptable criteria. However, variable degrees of percent deviations were observed according to sample type and storage conditions. Only EDTA PL samples presented clinically acceptable percentage biases for all three tumor markers when stored at room temperature or refrigerated condition. Positive bias of CEA and PSA in storage duration until 16 weeks were observed when stored in frozen condition. While IchromaTM II showed an adequate analytical performance as a POCT platform with simple operating procedures for the measurement of tumor markers, clinical laboratories should be aware of stability issues when different types of blood specimens are practically utilized.
Files in This Item:
T202405560.pdf Download
DOI
39111647
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Rim, John Hoon(임정훈) ORCID logo https://orcid.org/0000-0001-6825-8479
Lim, Jong Baeck(임종백) ORCID logo https://orcid.org/0000-0003-0419-0422
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/200594
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