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pISSN 2950-9114 eISSN 2950-9122
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Lab Med Qual Assur 2024; 46(1): 66-71

Published online March 31, 2024

https://doi.org/10.15263/jlmqa.2024.46.1.66

Copyright © Korean Association of External Quality Assessment Service.

Assessment of Long-Term Stability of External Quality Control Materials: Defibrinated Pooled Plasma for Examination of Hepatitis Viral Markers

Hyunhye Kang1,2 , Dong Wook Jekarl1,2 , Seung Hyo Yoo1 , Ae-Ran Choi1 , and Eun-Jee Oh1,2

1Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea; 2Research and Development Institute for In Vitro Diagnostic Medical Devices, Catholic University of Korea, Seoul, Korea

Correspondence to:Eun-Jee Oh
Department of Laboratory Medicine, Seoul St. Mary’s Hospital, College of Medicine, The Catholic University of Korea, 222 Banpo-daero, Seocho-gu, Seoul 06591, Korea
Tel +82-2-2258-1641
E-mail ejoh@catholic.ac.kr

Received: November 23, 2023; Revised: November 24, 2023; Accepted: November 27, 2023

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.

Abstract

Since 2016, the external quality assessment program of The Korean Association of External Quality Assessment Service for hepatitis serology has employed pooled serum specimens. Ten test items include hepatitis B virus surface antigen (HbsAg), hepatitis B virus surface antibody (anti-HBs), hepatitis B virus core antibody (anti-HBc) total, anti-HBc immunoglobulin M (IgM), hepatitis B virus envelope antigen (HBeAg), hepatitis B virus envelope antibody (anti-HBe), hepatitis C virus antibody (anti-HCV), hepatitis A virus antibody (anti-HAV) total, anti-HAV immunoglobulin G (IgG), and anti-HAV IgM. We aimed to evaluate the long-term stability of pooled serum specimens using fresh frozen plasma stored at different temperatures. In the first trial conducted in 2019, an additional 432 samples were prepared and tested for long-term stability at room temperature for 2 weeks, refrigerated for 1 month, and frozen (-20℃ and -80℃) for 6 months to 1 year. Furthermore, the stability of the samples was evaluated based on the number of repeated refrigeration and freezing cycles. The prepared pooled sera specimens for hepatitis serology were stable for up to 10 days at 2–8℃, 2–3 months at -20℃ and -80℃, and four freeze-thaw cycles, with the quantitative indices of all tests deviating within 10%. The results of this study are expected to contribute to the stable implementation and quality improvement of the hepatitis virus antigen-antibody test reliability survey project.

Keywords: Hepatitis serology, Stability, Pooled serum, External quality assessment, Fresh frozen plasma

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