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. 2023 May 1;43(3):273-279.
doi: 10.3343/alm.2023.43.3.273. Epub 2022 Dec 22.

Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

Hee Jin Huh  1 , Soo-Kyung Kim  2 , Jae-Woo Chung  1 , Soo Jin Yoo  3 , Kyoung Ho Roh  4 , Seok Lae Chae  1 , Young Joo Cha  5
Affiliations

Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody

Hee Jin Huh et al. Ann Lab Med. .

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°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.

Keywords: Anti-HIV-1 antibody; HIV; Reference standard.

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Conflict of interest statement

CONFLICTS OF INTEREST

None.

Figures

Fig. 1
Fig. 1
Real-time stability study results of candidate reference standards after storage at −70°C for 12 months. Abbreviations: MP, mixed-titer performance panel; S/CO, sample to cut-off index ratio.
See this image and copyright information in PMC

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