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

• Published in: Annals of laboratory medicine Vol. 43; no. 3; pp. 273 - 279
• Main Authors: Huh, Hee Jin, Kim, Soo-Kyung, Chung, Jae-Woo, Yoo, Soo Jin, Roh, Kyoung Ho, Chae, Seok Lae, Cha, Young Joo
• Format: Journal Article
• Language: English
• Published: Korea (South) 대한진단검사의학회 01-05-2023
• Subjects: HIV Infections - diagnosis; HIV-1; Humans; Quality Control; Reference Standards; 병리학; Anti-HIV-1 antibody; HIV; Reference standard
• ISSN: 2234-3806; 2234-3814
• DOI: 10.3343/alm.2023.43.3.273

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.
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.
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.
The overall results suggest that the 12 candidate standards could serve as national reference standards for anti-HIV-1 antibody.