J Lab Med Qual Assur 2014; 36(4): 161-170
Published online December 31, 2014
Copyright © Korean Association of External Quality Assessment Service.
Jun Hyung Lee1, Young Joo Cha1, Jae Hoon Bae1, and Seok Lae Chae2, as Immunoserology Subcommittee, The Korean Association of Quality Assurance for Clinical Laboratory
1Department of Laboratory Medicine, Chung-Ang University Hospital, Chung- Ang University College of Medicine, Seoul; 2Department of Laboratory Medicine, Dongguk University Ilsan Hospital, Dongkuk University College of Medicine, Goyang, Korea
Correspondence to:Young Joo Cha
Department of Laboratory Medicine, Chung-Ang University College of Medicine, 84 Heukseok-ro, Dongjak-gu, Seoul 156-861, 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/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
We performed two trials on the external quality assessment of viral markers and serological tests for syphilis (STS) organised by the Immunoserology Subcommittee of the Korean Association of Quality Assurance for Clinical Laboratories in 2013. In each trial, we delivered 3 kinds of pooled sera specimens to 1,021 institutions for external proficiency testing. Pooled sera were checked for their homogeneity and stability by using more than 3 other methods between the day of their manufacture and 3 days after despatching. The numbers of participating laboratories were 1,019 (99.8%) and 1,020 (99.8%) for the first and second trials, respectively. The most commonly tested items were hepatitis B surface antigen followed by antibody to hepatitis B surface antigen, anti-human immunodeficiency virus, anti-hepatitis C virus, STS, and anti-hepatitis B core. The most frequently used methods for detecting viral markers were the chemiluminescence immunoassay (CLIA) and the electrochemiluminescence immunoassay, which generated a few false positive results. In contrast, false negative results were frequently found through the immunochromatography assay, the use of which for detecting viral markers has been steadily increasing in recent years. The new tests, turbidoimmunoassay and CLIA, have recently been introduced for the measurement of non-treponemal and treponemal antibodies, and their use is also increasing. (J Lab Med Qual Assur 2014;36:161-170)
Keywords: Hepatitis B, Hepatitis C, HIV, Immunoassay, Laboratory proficiency testing, Serology, Syphilis
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