Application of recombinant hemagglutinin proteins as alternative antigen standards for pandemic influenza vaccines.

OBJECTIVES: The single radial immunodiffusion (SRID) assay, used to quantify hemagglutinin (HA) in influenza vaccines, requires reference reagents; however, because centralized production of reference reagents may slow the emergency deployment of vaccines, alternatives are needed. RESULTS: We investigated the production of HA proteins using recombinant DNA technology, rather than a traditional egg-based production process. The HA proteins were then used in an SRID assay as a reference antigen. We found that HA can be quantified in both egg-based and cell-based influenza vaccines when recombinant HAs (rHAs) are used as the reference antigen. Furthermore, we confirmed that rHAs obtained from strains with pandemic potential, such as H5N1, H7N3, H7N9, and H9N2 strains, can be utilized in the SRID assay. The rHA production process takes just one month, in contrast to the traditional process that takes three to four months. CONCLUSIONS: The use of rHAs may reduce the time required to produce reference reagents and facilitate timely introduction of vaccines during emergencies.

Comparison of different detection methods of monkey B virus antibody / 中国比较医学杂志

Objective Monkey B virus(BV), also known as Cercopithecine herpesvirus 1,is an important zoonotic pathogen.According to the national standard, antibodies are detected using BV as an antigen.However, the preparation of BV antigen is very stricted due to biosafety issues.Therefore, in this study, we used alternative antigens to detect the BV antibody by serological assay and verified their specifity and sensitivity.Methods A total of 135 blood samples from rhesus monkeys were tested by two ELISA method (BV and HVP2) and enzyme immunosorbent assay (EIA)method.The positive and suspicious samples were verified by immuno-fluorescence assay (IFA), Western blot and immunoblotting technique using HSV-1 gC1 purified glycoprotein as an antigen.Results The positive rates of HVP2-ELISA, BV-ELISA and HSV-1-EIA were 32.6%, 37.8% and 34.8%, respectively.Consistant result of the three detection method accounted for 91.1% (123/135), and the positive result were confirmed by IFA And WB.There were 12 suspicious samples,in which 33.3% (4/12) were verified to be positive.Conclusions Compared with BV antigen, the sensitivity and specificity of the alternative antigen HSV-1 are moe close than HVP2.Positive and suspicious samples should be verified by several method to avoid missed detection.