Establishment of serum reference for neutralizing antibody detection of mpox virus
10.13200/j.cnki.cjb.004722
- VernacularTitle:猴痘病毒中和抗体检测血清参考品的建立
- Author:
Chunxia HU
- Publication Type:Journal Article
- Keywords:
Mpox virus;
Serum reference;
Neutralizing antibody detection
- From:
Chinese Journal of Biologicals
2026;39(06):667-671+678
- CountryChina
- Language:Chinese
-
Abstract:
Objective To prepare serum reference for the detection of mpox virus neutralizing antibodies and study its stability.Methods Serum from cynomolgus monkeys successfully infected with mpox virus was collected,heat-inactivated,filtered,and aliquoted,followed by sterility testing,mycoplasma testing,and mycobacterial testing.Specificity and homoge-neity detection,determination of limit of detection(LOD),calibration test and stability test were then conducted.Results The prepared serum reference material for mpox virus neutralizing antibody detection met the sterility,mycoplasma,and mycoba-cterium testing requirements of the Chinese Pharmacopoeia(Volume Ⅲ,2020 edition).It was specific to mpox virus,the neut-ralizing antibody titer measured by plaque reduction neutralization test(PRNT) was 331,and the titer range was 79-1 380,with good uniformity[F = 0.21,< F_(0.05)(24,50)].The titer calibrated by anti-mpox antibody working reagent(NIBSC code:22/218) was 500,and the reference material exhibited excellent stability when stored at-80 ℃ for 18 months.Conclusion A reference material for mpox virus neutrali-zing antibodies was prepared,demonstrating good stability and suitability for evaluating the neutralizing antibody titer of mpox virus vaccines or drugs.
