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KMID : 1100720230430030273
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Annals of Laboratory Medicine
2023 Volume.43 No. 3 p.273 ~ p.279
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Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
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Huh Hee-Jin
Kim Soo-Kyung
Chung Jae-Woo
Yoo Soo-Jin
Chae Seok-Lae
Roh Kyoung-Ho
Cha Young-Joo
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Abstract
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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.
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KEYWORD
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Anti-HIV-1 antibody, HIV, Reference standard
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