CALIBRATION OF NATIONAL RABIES STANDARDS VACCINE LOT RRAB01-01
DOI:
https://doi.org/10.56086/jcvb.v4i1.140Keywords:
National rabies standard vaccine, calibration, NIH method, RRab01-01Abstract
In 2003, National Institute for Control of Vaccines and Biologicals (NICVB) established a national standard vaccine (MCQG) for rabies lot RRab01-01 with 2500 freeze-dried vials, potency of 11.0 IU/vial and stored at -70oC at the Reference Standard Department. By 2023, there will still be 2,320 vials remain. To ensure that this national standard vaccine still meets specifications, periodic calibration is very important and urgent, especially when there are changes in mouse strains in the routine testing. Therefore, in 2023, the Department of Viral Vaccines will re-calibrate the national standard vaccine model according to the NIH method, the study is carried out 6 times on 6 different days, by the same group with the same chemical conditions, materials, equipment, ICR mouse line and use international standard lot 07/162 of NIBSC for calibration. The results showed that the average potency value of lot RRab01-01 was 9.3 IU/vial (15.1% reduction) with coefficient of variation CV = 10.4%. Thus, the national rabies standard vaccine lot RRab01-01 still meets the requirements with the set standards ≥ 5 IU/tube and is guaranteed to be used for routine testing at National Institute for Control of Vaccines and Biologicals (NICVB).
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