Jo Miran, Lee Eunjo, Oh Ho Jung, Hong Jin Tae, Sohn Kyung Hee
National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju 28159, Republic of Korea.
College of Pharmacy, Chungbuk National University, Cheongju 28160, Republic of Korea.
Biosaf Health. 2025 Jul 16;7(4):224-227. doi: 10.1016/j.bsheal.2025.07.007. eCollection 2025 Aug.
Despite the development of messenger ribonucleic acid (mRNA) vaccines for the infectious novel coronavirus 2 (SARS-CoV-2), further research on test methods is required to ensure their quality as well as rapid and effective approval for release to the market. During the current national lot release testing, identity tests cannot be conducted on other products using primers, probes, and in-house reference materials provided by the manufacturer and specific to one vaccine, because their sequences do not match. When key reagents and reference materials are dependent on the manufacturer in this way, difficulties in national lot release approval-which serves as an additional step for the government to verify product quality-arise if the manufacturer does not provide them. In this study, we aimed to develop a quantitative polymerase chain reaction (qPCR) assay by using commercially available nucleic acid amplification test (NAT) reference material and a dye instead of a probe along with primers that were newly designed in this study. It can be applied to both vaccines. This study suggests a test method that can be applied when the in-house reference standard for the identity test, a major step to confirm the quality of vaccines, is not secured.
尽管针对新型冠状病毒2（SARS-CoV-2）开发了信使核糖核酸（mRNA）疫苗，但仍需要对检测方法进行进一步研究，以确保其质量，并实现快速有效的上市批准。在当前的国家批签发检测中，无法使用制造商提供的、针对一种疫苗的引物、探针和内部参考材料对其他产品进行鉴别试验，因为它们的序列不匹配。当关键试剂和参考材料以这种方式依赖于制造商时，如果制造商不提供，作为政府验证产品质量的额外步骤的国家批签发批准就会出现困难。在本研究中，我们旨在开发一种定量聚合酶链反应（qPCR）检测方法，使用市售核酸扩增检测（NAT）参考材料和一种染料代替探针，以及本研究新设计的引物。它可应用于两种疫苗。本研究提出了一种检测方法，当作为确认疫苗质量的主要步骤的鉴别试验的内部参考标准无法获得时，可以应用该方法。
