Stability Evaluation of Ring Antigen Produced by RVSRI

BACKGROUND AND OBJECTIVESThe Milk Ring Test (MRT) is valuable and useful in detecting Brucella antibody in milk. The evaluation of the stability of this antigen is used to confirm its effectiveness and its expiration date. It plays an important role in ensuring the quality of the product. Therefore, it is necessary to monitor the antigen ring test produced by Razi Vaccine and Serum Research Institute (RVSRI) and in order to determine the maximum shelf life of the antigen ring test.MATERIALS AND METHODS۱۰۰ sample vials of three series of antigen produced by RVSRI were performed in accelerated and long term stability methods. In the accelerated stability studies, the products were examined at a temperature of ۳۷ degrees for a period of up to ۳ months, which is approximately equivalent to three years. Another method is to examine long-term stability studies, where the vaccine is placed in the recommended storage conditions of +۴ to ۳۶ months and +۲۵ to ۱۸ months. The following tests were performed including inactivity of Brucella abortus bacteria, the amount of mass per unit volume, the amount of phenol, pH level, purity and identity, the positive and negative control of the antigen.RESULTS AND DISCUSSIONThe results of the long-term stability studies showed that the antigen was confirmed and in accordance with the OIE standard. All the samples had similar results to the samples tested in the long-term evaluation method. This study showed that the MRT antigen produced by RVSRI was within the standard range in the time frame of the performed tests (۲ and a half years), which lasts up to three years of study.CONCLUSIONBased on years of experience, all the antigens produced by Razi Vaccine and Serum Research Institute can be used for years provided that they are kept in proper storage conditions (۲ to ۸°C) and that autoagglutination in the antigen has not been occurred

کلیدواژه ها:

Antigen ، Milk Ring Test ، Stability ، Brucellosis