期刊
VIROLOGY JOURNAL
卷 12, 期 -, 页码 -出版社
BMC
DOI: 10.1186/s12985-015-0333-1
关键词
Varicella; Vaccine; Virus content; National Center for Lot Release; Korean reference material
类别
资金
- National Institute of Food and Drug Safety Evaluation of the Ministry of Food and Drug Safety, Republic of Korea [12171KFDA316]
Background: In Korea, every vaccine lot is tested by the National Center for Lot Release (NCLR) in accordance with the national lot release procedures to ensure the safety and efficacy of vaccines. These quality tests examine the virus content in varicella vaccines via plaque assays (either the agar overlay method [AOM] or plaque staining method [PSM]), according to the procedures suggested by the Korean Reference Material for the Varicella Vaccine (KRMVV) or the manufacturer's standard in-house protocol. Aim: To standardize the virus content tests, viral titers in the KRMVV were measured using the PSM at four participating laboratories in a collaborative study. With the aim of developing a standardized method using the KRMVV as a positive control, we compared the ability of the two test methods, AOM and PSM, to accurately and reproducibly determine the virus content of two commercial varicella vaccines. Results: The results showed that the standardized method (PSM) was more suitable for quality control analysis of the varicella vaccine. Conclusion: Use of a standardized method (PSM) according to the Korean reference material will improve the reliability and objectivity of lot release testing.
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