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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
E-mail: seo2023@nate.com
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 (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.
 Abstract
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
References
  1. Lee SH. Update on laboratory testing for diagnosing HIV infection. Korean J Med 2016;90:469-73.
    CrossRef
  2. Choi JY. Updates on preventing HIV infection. Korean J Med 2016;90:474-80.
    CrossRef
  3. Min WK. Laboratory quality management. In: Korean Society for Laboratory Medicine, editor. Laboratory medicine. 5th ed. Seoul: PanMun, 2014:41-7.
  4. Lee JS, Park KY, Kim SS, Suh SD, Park HK, Hwang YS, et al. Report on external quality assessment of HIV antibody test (1998). J Clin Pathol Qual Control 1999;21:355-62.
  5. Kim SS, Suh SD, Kim OJ, Lee MW, Lee JS, Kim HS, et al. External quality assessment in anti-HIV enzyme immunoassay in Korea. J Clin Pathol Qual Control 2000;22:293-301.
  6. Cha YJ. The results of external proficiency tests to prevent transfusion-transmitted virus infection: there is a need for a quality assurance program for donor screening tests to prevent blood-borne virus infections. Korean J Blood Transfus 2010;21:25-35.
  7. Kim HS, Wang JS, Kee MK, Park J, Kim YR, Lee YR, et al. The current status of HIV serologic testing in Korean clinical laboratories during the year 2007. Korean J Blood Transfus 2008;19:207-15.
  8. Ferguson M, Holmes H, Sands D. National Institute for Biological Standards and Control/UK Blood Transfusion Service working standards for HBsAg, anti-HCV and anti-HIV-1 (쁤o/no-go controls). Vox Sang 2001;80:20510.
    CrossRef
  9. Miller WG, Jones GR, Horowitz GL, Weykamp C. Proficiency testing/external quality assessment: current challenges and future directions. Clin Chem 2011;57:1670-80.
    Pubmed CrossRef
  10. Lee K, Park HD, Kang ES. Reduction of the HIV seroconversion window period and false positive rate by using ADVIA Centaur HIV antigen/antibody combo assay. Ann Lab Med 2013;33:420-5.
    Pubmed KoreaMed CrossRef
  11. Korea Centers for Disease Control and Prevention. Development of HIV standard materials serologic external quality assurance program. Cheongju: Korea Centers for Disease Control and Prevention, 2015.
  12. Kim KC, Sim HJ, Park MN, Choi BS, Kang C. Effect of early HIV diagnosis by introduction of acute HIV confirmatory testing algorithm. Public Health Wkly Rep 2016;9:399-404.
  13. Korean Standards Association. KS A ISO guide 34: general requirements for the competence of reference material producers. Seoul: Korean Standards Association, 2005.
  14. Korean Standards Association. KS A ISO guide 31: reference materials-contents of certificates and labels. Seoul:Korean Standards Association, 2005.
  15. Parekh BS, Anyanwu J, Patel H, Downer M, Kalou M, Gichimu C, et al. Dried tube specimens: a simple and cost-effective method for preparation of HIV proficiency testing panels and quality control materials for use in resource-limited settings. J Virol Methods 2010;163:295300.
    Pubmed CrossRef