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Collaborative Study to Establish National Reference Standards for Anti-HIV-1 Antibody
Hee Jin Huh1, Soo-Kyung Kim2, Jae-Woo Chung1
1Department of Laboratory Medicine, Dongguk University Ilsan Hospital, Goyang, Korea.
Annals of Laboratory Medicine
|December 22, 2022
Summary
National reference standards for anti-HIV-1 antibody were developed and validated. The 12 candidate standards demonstrated stability and consistent performance across multiple assays, supporting their use in quality control.
Area of Science:
- Immunology
- Virology
- Biotechnology
Background:
- Reliable national reference standards are crucial for evaluating anti-HIV-1 antibody assays.
- Quality control of HIV diagnostics necessitates well-characterized reference materials.
Purpose of the Study:
- To prepare a mixed-titer performance panel for anti-HIV-1 antibody.
- To assess the suitability of this panel as a national reference standard.
Main Methods:
- Prepared 10 positive and 2 negative anti-HIV-1 antibody candidate standards from patient samples.
- Conducted a collaborative study across eight laboratories using five different assays.
- Evaluated real-time and accelerated stability at -70°C and -20°C.
Main Results:
- All 10 candidate standards showed positive results across five anti-HIV-1 antibody assays in the collaborative study.
- Coefficient of Variation (CV) was within 10% for most assay results.
- No stability trends were observed at -70°C or -20°C, indicating long-term stability.
Conclusions:
- The 12 candidate standards are suitable for use as national reference standards for anti-HIV-1 antibody.
- These standards can aid in maintaining the quality and performance of HIV diagnostic assays.
