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Stability of lyophilized pooled sera as quality control materials for tumor marker assays in external quality assessment

Authors
 Sunyoung Ahn  ;  Jungyong Park  ;  Young Ran Kim  ;  Jeong-Ho Kim  ;  Hyon-Suk Kim 
Citation
 CLINICA CHIMICA ACTA, Vol.471 : 233-242, 2017 
Journal Title
 CLINICA CHIMICA ACTA 
ISSN
 0009-8981 
Issue Date
2017
MeSH
Biomarkers, Tumor/blood* ; Blood Specimen Collection* ; Clinical Laboratory Techniques* ; Freeze Drying ; Humans ; Neoplasms/blood* ; Quality Control*
Keywords
External quality assessment ; Lyophilization ; Quality control ; Stability ; Tumor marker
Abstract
BACKGROUND: External quality assessment (EQA) requires stable quality control (QC) materials. We evaluated the stability of QC materials made of lyophilized and liquid pooled sera for the tumor markers α-fetoprotein, carcinoembryonic antigen, carbohydrate antigen 125, and carbohydrate antigen 19-9. METHODS: Specimens of the 4 tumor markers were collected from the sera of patients and stored at -20°C. After sera collection and pooling, liquid or lyophilized samples were stored at -20°C, 5°C, or room temperature. Tumor markers were quantified on days 0, 1, 4, 7, 14, 30, and 90 of storage. Internal QC results were analyzed, and the effects of heat inactivation and sucrose addition were assessed. RESULTS: Heat inactivation lowered tumor marker levels in lyophilized pooled sera, whereas sucrose addition had no effect. The coefficients of variation of the internal QC results were stable, whereas those of lyophilized samples were higher than those of liquid samples. Tumor marker levels were significantly lower in lyophilized samples (p<0.05) and did not significantly differ according to storage temperature. A declining trend over time was observed for all tumor markers. CONCLUSIONS: Lyophilized QC materials are insufficiently stable for use in EQA among clinical laboratories.
Full Text
https://www.sciencedirect.com/science/article/pii/S0009898117302243
DOI
10.1016/j.cca.2017.05.035
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Laboratory Medicine (진단검사의학교실) > 1. Journal Papers
Yonsei Authors
Kim, Young Lan(김영란)
Kim, Jeong Ho(김정호) ORCID logo https://orcid.org/0000-0003-2479-0548
Kim, Hyon Suk(김현숙) ORCID logo https://orcid.org/0000-0001-5662-7740
Park, Jungyong(박정용)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/161250
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