Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
10.3343/alm.2023.43.3.273
- Author:
Hee Jin HUH
1
;
Soo-Kyung KIM
;
Jae-Woo CHUNG
;
Soo Jin YOO
;
Kyoung Ho ROH
;
Seok Lae CHAE
;
Young Joo CHA
Author Information
1. Department of Laboratory Medicine, Dongguk University Ilsan Hospital, Goyang, Korea
- Publication Type:Original Article
- From:Annals of Laboratory Medicine
2023;43(3):273-279
- CountryRepublic of Korea
- Language:English
-
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.
