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Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
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...
Autores principales: | , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Korean Society for Laboratory Medicine
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9791019/ https://www.ncbi.nlm.nih.gov/pubmed/36544339 http://dx.doi.org/10.3343/alm.2023.43.3.273 |
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author | Huh, Hee Jin Kim, Soo-Kyung Chung, Jae-Woo Yoo, Soo Jin Roh, Kyoung Ho Chae, Seok Lae Cha, Young Joo |
author_facet | Huh, Hee Jin Kim, Soo-Kyung Chung, Jae-Woo Yoo, Soo Jin Roh, Kyoung Ho Chae, Seok Lae Cha, Young Joo |
author_sort | Huh, Hee Jin |
collection | PubMed |
description | 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°C or −20°C, supporting that the reference standards were maintained in a stable state at −70°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. |
format | Online Article Text |
id | pubmed-9791019 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Korean Society for Laboratory Medicine |
record_format | MEDLINE/PubMed |
spelling | pubmed-97910192023-01-06 Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody Huh, Hee Jin Kim, Soo-Kyung Chung, Jae-Woo Yoo, Soo Jin Roh, Kyoung Ho Chae, Seok Lae Cha, Young Joo Ann Lab Med Original Article 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°C or −20°C, supporting that the reference standards were maintained in a stable state at −70°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. Korean Society for Laboratory Medicine 2023-05-01 2022-12-22 /pmc/articles/PMC9791019/ /pubmed/36544339 http://dx.doi.org/10.3343/alm.2023.43.3.273 Text en © Korean Society for Laboratory Medicine https://creativecommons.org/licenses/by-nc/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0 (https://creativecommons.org/licenses/by-nc/4.0/) ) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited. |
spellingShingle | Original Article Huh, Hee Jin Kim, Soo-Kyung Chung, Jae-Woo Yoo, Soo Jin Roh, Kyoung Ho Chae, Seok Lae Cha, Young Joo 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 |
title_full | Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody |
title_fullStr | Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody |
title_full_unstemmed | Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody |
title_short | Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody |
title_sort | collaborative study to establish national reference standards for anti-hiv-1 antibody |
topic | Original Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9791019/ https://www.ncbi.nlm.nih.gov/pubmed/36544339 http://dx.doi.org/10.3343/alm.2023.43.3.273 |
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