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Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
- Title
- Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
- Authors
- Huh, Hee Jin; Kim, Soo-Kyung; Chung, Jae-Woo; Yoo, Soo Jin; Roh, Kyoung Ho; Chae, Seok Lae; Cha, Young Joo
- Ewha Authors
- 김수경
- SCOPUS Author ID
- 김수경
- Issue Date
- 2023
- Journal Title
- ANNALS OF LABORATORY MEDICINE
- ISSN
- 2234-3806
2234-3814
- Citation
- ANNALS OF LABORATORY MEDICINE vol. 43, no. 3, pp. 273 - 279
- Keywords
- Anti-HIV-1 antibody; HIV; Reference standard
- Publisher
- KOREAN SOC LABORATORY MEDICINE
- Indexed
- SCIE; SCOPUS; KCI
- Document Type
- Article
- 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 Laborato-ries, 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 posi-tive for all 10 candidate standards prepared using HIV patient samples. The CV of each as-say for every candidate standard was within 10%, except for one assay result. No real-time and accelerated stability change trend was observed at -70 degrees C or -20 degrees C, supporting that the reference standards were maintained in a stable state at -70 degrees C 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.
- DOI
- 10.3343/alm.2023.43.3.273|http://dx.doi.org/10.3343/alm.2023.43.3.273
- Appears in Collections:
- 의료원 > 의료원 > Journal papers
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