Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
نویسنده : Hee Jin Huh , Soo-Kyung Kim , Jae-Woo Chung , Soo Jin Yoo , , Kyoung Ho Roh , Seok Lae Chae , , and Young Joo Cha
تاریخ انتشار : 1402/02/05
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 antiHIV-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