Ann Lab Med.  2023 May;43(3):273-279. 10.3343/alm.2023.43.3.273.

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

• Huh HJ
• Kim SK
• Chung JW
• Yoo SJ
• Roh KH
• Chae SL
• Cha YJ

• KMID: 2551711
• DOI: http://doi.org/10.3343/alm.2023.43.3.273

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.

Keyword

Anti-HIV-1 antibody; HIV; Reference standard

Figure

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  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.

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