Ensuring mRNA vaccine identity: qualification of an RT-qPCR assay for COVID-19 vaccine verification

Key Points

• This research aims to qualify an RT-qPCR assay for the verification of mRNA COVID-19 vaccines.
• Developed and validated an RT-qPCR assay for mRNA vaccines.
• Conducted assays to determine assay performance metrics.
• Assessed the assay's ability to verify vaccine mRNA integrity.
• The RT-qPCR assay shows high sensitivity and specificity for identifying vaccine mRNA.
• Successful verification of all tested vaccine samples, demonstrating 100% accuracy.