CALIBRATION OF JAPANESE ENCEPHALITIS REFERNCE STANDARD STRAIN NAKAYAMA
DOI:
https://doi.org/10.56086/jcvb.v4i1.135Keywords:
Japanese encephalitis reference standard, calibration, PRNT50 methodAbstract
Japanese encephalitis (JE) reference standard vaccine strain Nakayama is a production in Government level project in 2003 that has used as a biological reference in quality control of inactivated Japanese encephalitis vaccine. To ensure the quality of JE reference standard vaccine strain Nakayama, periodic calibration is very important and necessary, especially when there is a change in mouse line of routine procedure. This project used cross-sectional descriptive study in the laboratory and Plaque reduction neutralization test 50% (PRNT50) is applied to calibrate JE reference standard vaccine. The result showed that the average potency value of JE reference standard vaccine strain Nakayama was 1,665 log PRNT50 and passed the criteria (≥ 1,30 log PRNT50) with coefficient variation (CV) < 25%. Therefore, JE reference standard vaccine strain Nakayama is still ensured to apply for routine procedure at National Institute for Control of Vaccines and Biologicals (NICVB).
References
Nguyễn Đình Bảng. “Nghiên cứu sản xuất một số mẫu chuẩn Quốc gia vắc xin và sinh phẩm để tiêu chuẩn hóa sản phẩm vắc xin và sinh phẩm Việt Nam”. Đề tài cấp nhà nước mã KC-10-01, 2003.
LabCE. “Plaque Reduction Neutralization Tests (PRNT)”, 2016. Available at: https://www.labce.com/spg1050613_plaque_reduction_neutralization_tests_prnt.aspx
Phan Thị Ngà. “Dịch tễ học phân tử vi rút viêm não Nhật Bản”, NXB y học Hà Nội, 2014.
Pankaj Sharma, Veena Mittal, Mala Chhabra, Priyanka Singh, Lakhvir Singh Chauhan, Arvind Rai. “An Update on JE Vaccine Development and Use”. J. Commun. Dis. 2014; 46(1): 109- 118.
SOP-KĐQG-28: “Quy trình chuẩn hướng dẫn thiết lập và đánh giá chất lượng mẫu chuẩn”, NICVB
SOP-VR03-01: “Quy trình chuẩn thử nghiệm công hiệu nhận dạng vắc xin viêm não Nhật Bản bất hoạt”, NICVB.
SOP QC-BIO-14. “Công hiệu vắc xin viêm não Nhật Bản”. Vabiotech
WHO. “Recommendations for the preparation, characterization and establishment of international and other biological reference standards”, WHO TRS, No. 932, 2006.
WHO. “Recommendation to assure the quality, safety and efficacy of JE vaccine (inactivated)”,WHO TRS 963, 2011.
Yun SI, Lee YM. “Japanese encephalitis: The virus and vaccines”. Hum
Vaccin Immunother 2013; 10: 1-17
