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Development of External Quality Controls for Human Immunodeficiency Virus Antigen/Antibody Tests in Korea
J Lab Med Qual Assur 2018;40:92-100
Published online June 30, 2018
© 2018 Korean Association of External Quality Assessment Service.

Dong Hee Seo1,2, Yeo Rin Choi1, Won Woong Choi1, Cheol Hee Yoon3, Byeong Sun Choi3, Yoon-Seok Chung3, and Chun Kang3

1WON Medical Corporation, Bucheon;
2LabGenomics Clinical Laboratories, Seongnam;
3Division of AIDS, Centers for Disease Control & Prevention, Cheongju, Korea
Correspondence to: Dong Hee Seo
LabGenomics Clinical Laboratories, 700 Daewangpangyo-ro, Bundanggu, Seongnam 13488, Korea
Tel: +82-31-628-0730
Fax: +82-31-628-0701
Received December 15, 2017; Revised April 3, 2018; Accepted April 11, 2018.
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background: Quality control is important for accurate diagnosis of human immunodeficiency virus (HIV) infection, and proficiency testing with external quality controls is an important part of quality control. This study intended to develop and supply customized external quality controls for HIV antigen/antibody testing fitted with currently used reagents for standardization of HIV infection diagnosis and evaluation of HIV testing competency of laboratories in Korea.
Methods: Serological tests and inactivation were performed on the obtained HIV antibody positive plasma. To manufacture quality controls having the required antibody titers, dilution ratio was searched using VIDAS (bioM챕rieux, France), Architect (Abbott Laboratories, USA), and Cobas 8000 (Roche Diagnostics, Germany) analyzers. Diluted source plasma was divided into aliquots after filtering. Homogeneity and stability of the produced external quality controls were evaluated.
Results: The collected HIV antibody positive plasma was confirmed by Western blot. Dilution ratios for source plasma were produced for each analyzer showing signal-to-cutoff 23, 57, and 1516 reactivity. Diluted plasma was made to 1 mL aliquots and total set of 1,500 external quality controls for HIV antigen/antibody were manufactured. Produced controls satisfied the required criteria of homogeneity and showed less than 10% coefficient of variation for stability except negative controls.
Conclusions: Customized external quality controls were developed and qualified for HIV testing reagents used in Korea. Continuous external quality control assessment for HIV tests with controls would be required.
Keywords : HIV, Quality control, Antibody, Proficiency test
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