Annals of Laboratory Medicine

Korean Society for Laboratory Medicine (대한진단검사의학회)
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Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

  • Hee Jin Huh (Department of Laboratory Medicine, Dongguk University Ilsan Hospital) ;
  • Soo-Kyung Kim (Department of Laboratory Medicine, Ewha Womans University College of Medicine) ;
  • Jae-Woo Chung (Department of Laboratory Medicine, Dongguk University Ilsan Hospital) ;
  • Soo Jin Yoo (Department of Laboratory Medicine, Sanggye Paik Hospital, Inje University College of Medicine) ;
  • Kyoung Ho Roh (Department of Laboratory Medicine, National Health Insurance Service Ilsan Hospital) ;
  • Seok Lae Chae (Department of Laboratory Medicine, Dongguk University Ilsan Hospital) ;
  • Young Joo Cha (Laboratory Medicine, Biobank Team, Institut Pasteur Korea)
  • Received : 2022.07.05
  • Accepted : 2022.09.29
  • Published : 2023.05.01
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Abstract

Background: National reference standards for anti-HIV-1 antibody are needed to evaluate the performance and maintain the quality control of anti-HIV-1 antibody assays. The aim of this study was to prepare a mixed-titer performance panel and assess its suitability as a national reference standard for anti-HIV-1 antibody according to stability, collaboration, and other studies. Methods: Nineteen serum samples from different HIV patients were obtained, along with 15 units of fresh frozen plasma samples with negative anti-HIV-1 antibody results. Ten anti-HIV-1 antibody-positive candidate standards and two negative candidate standards were prepared based on the reactivity in the Alinity i HIV Ag/Ab combo assay (Abbott Laboratories, Wiesbaden, Germany). A collaborative study was conducted across eight laboratories using five anti-HIV-1 antibody assays. Real-time and accelerated stability were evaluated to assess the long-term stability. Results: In the collaborative study, results of all five anti-HIV-1 antibody assays were positive for all 10 candidate standards prepared using HIV patient samples. The CV of each assay for every candidate standard was within 10%, except for one assay result. No real-time and accelerated stability change trend was observed at -70℃ or -20℃, supporting that the reference standards were maintained in a stable state at -70℃ for long-term storage. Conclusions: The overall results suggest that the 12 candidate standards could serve as national reference standards for anti-HIV-1 antibody.

Keywords

Acknowledgement

This study was supported by the High-Risk Human Serum Bank (2017M3A9B8069581), Ministry of Science and ICT, through the Bio & Medical Technology Development Program of the National Research Foundation of Korea (NRF) and the Ministry of Food and Drug Safety (19173MFDS317).

References

  1. WHO. Latest HIV estimates and updates on HIV policies uptake 2021. https://cdn.who.int/media/docs/default-source/hq-hiv-hepatitis-and-stislibrary/2021_global_summary_web_v32.pdf?sfvrsn=4b8815ad_30 (Updated on Mar 2022).
  2. Korea Disease Control and Prevention Agency. Annual report on the notified HIV/AIDS in Korea 2020. http://www.kdca.go.kr/filepath/boardDownload.es?bid=0031&list_no=717120&seq=1 (Updated on Mar 2022).
  3. Korean Association of External Quality Assessment Service. Annual report on external quality assessment 2021. https://keqas.org/ (Updated on Mar 2022).
  4. List of Ministry of Food and Drug Safety Reference Standards. http://www.nifds.go.kr/brd/m_212/view.do?seq=18700&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=6 (Updated on Sep 2022).
  5. ISO. ISO Guide 35:2017. Reference materials—Guidance for characterization and assessment of homogeneity and stability. Switzerland: International Organization for Standardization, 2017. https://www.iso.org/standard/60281.html (Updated on Sep 2022).
  6. WHO. Recommendations for the preparation, characterization and establishment of international and other biological reference standards (revised 2004). Technical Report Series; No. 932, Annex 2. Geneva, Switzerland: World Health Organization, 2006. https://www.who.int/publications/m/item/annex2-trs932 (Updated on Sep 2022).
  7. Castro AR, Kikkert SE, Fears MB, Pope V. Defibrination of blood plasma for use in serological tests for syphilis. Clin Diagn Lab Immunol 2002;9: 1376-8. https://doi.org/10.1128/CDLI.9.6.1376-1378.2002
  8. CLSI. Evaluation of stability of in vitro diagnostic reagents; approved guideline. CLSI EP25-A. Wayne, PA: Clinical and Laboratory Standards Institute, 2009.
  9. Korean Ministry of Food and Drug Safety. Guidebook on Ministry of Food and Drug Safety reference standards, 2022. https://www.nifds.go.kr/brd/m_212/view.do?seq=33133&srchFr=&srchTo=&srchWord=&srchTp=&itm_seq_1=0&itm_seq_2=0&multi_itm_seq=0&company_cd=&company_nm=&page=4 (Updated on Sep 2022).
  10. Stone M, Bainbridge J, Sanchez AM, Keating SM, Pappas A, Rountree W, et al. Comparison of detection limits of fourth- and fifth-generation combination HIV antigen-antibody, p24 antigen, and viral load assays on diverse HIV isolates. J Clin Microbiol 2018;56: e02045-17. https://doi.org/10.1128/JCM.02045-17
  11. Park YH, Roh JH, Kim SY. Performance evaluation of the Aptima assays in comparison with the cobas 6800 assays for the detection of HIV-1, HBV, and HCV in clinical samples. Ann Lab Med 2022;42:447-56. https://doi.org/10.3343/alm.2022.42.4.447
  12. Yang YC, Yang-Chih Shih D, Tsai MH, Cheng CH, Cheng HF, Lo CF, et al. A collaborative study to establish the first National Standard for HIV1 RNA nucleic acid amplification techniques (NAT) in Taiwan. J Virol Methods 2013;191:122-7.
  13. World Health Organization & WHO Expert Committee on Biological Standardization. Collaborative study to evaluate the proposed WHO 4th international standard for hepatitis B virus (HBV) DNA for nucleic acid amplification technique (NAT) based assays. Geneva, Switzerland: World Health Organization, 2016. https://apps.who.int/iris/bitstream/handle/10665/253052/WHO-BS-2016.2291-eng.pdf?sequence=1&isAllowed=y (Updated on Sep 2022).
  14. World Health Organization & WHO Expert Committee on Biological Standardization. WHO/BS.2020.2403. Establishment of the WHO International Standard and Reference Panel for anti-SARS-CoV-2 antibody. https://www.who.int/publications/m/item/WHO-BS-2020.2403 (Updated on Nov 2022).
  15. Park TJ, Choi CW, Oh HK, Kim JO, Kim BK, Kang HK, et al. Stability evaluation of national reference standards for blood products in Korea. Toxicol Res 2017;33:225-31. https://doi.org/10.5487/TR.2017.33.3.225