2023-07-14-世界卫生组织-WHO_BS_2023.2463_WHO_Reference_Reagent_for_antibodies_to_Ross_River_virus_46页_678kb

WHO International Reference Reagent for Anti-Ross River Virus Neutralizing Antibodies (IgG)

This collaborative study aimed to evaluate a candidate WHO International Reference Reagent (RR) for anti-Ross River Virus (RRV) neutralizing antibodies. RRV is an arbovirus causing significant morbidity, but no vaccines or specific treatments exist.

Key Findings and Recommendations:

1. Candidate RR Development:

   • A pooled plasma from anti-RRV IgG-positive donations underwent testing for specificity and safety, confirmed by sequencing and NAT assays.
   • The candidate RR (1500/19) was lyophilized and assigned an arbitrary unitage of 1,000 units (U)/ml for neutralization.

2. Collaborative Validation:

   • 10/11 laboratories participated, using various neutralization (virus-based, pseudovirus) and binding assays (ELISA, IFA, microsphere immunoassays).
   • Results demonstrated harmonization of neutralization and binding assay data across laboratories when referenced to RR1500/19, reducing inter-assay variability.

3. Stability and Performance:

   • The RR showed stability under recommended conditions (-20°C) for 3 years; accelerated studies indicated acceptable stability even at elevated temperatures.
   • Cross-reactivity with Chikungunya virus (Serili Forest complex) was noted, but RRCoreApplication could still harmonize data.

4. Conclusion:

   • RR1500/19 (1,000 U/ml) is recommended as the 1st WHO International Reference Reagent for anti-RRV neutralizing IgG antibodies.
   • This standard will facilitate global serological assays, vaccine development, and better epidemiological surveillance of RRV.