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Abstract
The quality control test of grouper iridovirus inactivated vaccine developed by AHRI was conducted according to the Guideline of Examinations Standard Procedures for Veterinary Drugs (R.O.C.), and the List of Guideline of Animal Bio-pharmaceutical, Material Preparation, Sampling Criteria and the Processing Period for Iridovirus Disease Inactivated Vaccine updated on November 15th, 2011 of Japan. After the semi products reached the assay standards of virus content and virus inactivated test, the virus and materials then finished the further processing. The vaccine products should be qualified for sterility test, safety test as well as efficacy test and then were sent for its national examination. Up to present, we have finished QC tests of 4 batches (batch number: 9901, 9902, 9903, and 10001). The first several batches vaccines were produced for emergency epidemic prevention. There was only 6 months validity of the vaccine at that time.. After that , the stability test of the vaccine was performed and the result could meet the QC standards requirements. Accordingly, we have applied to the regulatory authority for its validity period extension from 6 to 9 months.
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Abstract
The detection test was conducted to screen healthy macaques for experimental uses. Published studies indicated that serum samples were first screened for the presence of simian T-cell lymphotropic virus (STLV) antibodies by enzyme-linked immunosorbent assay (ELISA), immunofluorescence assay (IFA), or particle agglutination (PA) test. Positive or borderline samples were then tested by Western blot assay for final confirmation. The previous results tested by commercial ELISA kits showed one suspected case of STLV. The suspected STLV serum sample was tested by Western blot assay and the result turned out to be negative. Because it has been found the presence of antigen with the absence of antibody in latent infection case of STLV, We further investigated the presence of STLV antigen in macaques. The proviral DNA of STLV was detected by PCR and all blood samples showed negative. According to the above results of ELISA, Western blot, and PCR, these macaques neither carry STLV nor are infected with STLV. The STLV-free macaques meet the health requirement for experimental purposes.
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