Objective: To provide technical support for mRNA vaccine quality control by compareing with 3 methods of homogeneous time resolved fluorescence(HTRF),enzyme linked immunosorbent assay(ELISA) and Dot Blot for detecting dsRNA residues. Methods: According to the characteristics of HTRF,ELISA and Dot Blot assay respectively, the standards with different concentration were prepared and the dsRNA residues of samples were calculated by the standard curve. And tests were investigated in applicability, accuracy, precision, limit of quantitation and non-linear response. Results: The HTRF method showed that the recovery was 110.7% with the RSD of repeatability and intermediate precision were 5.6% and ≤19.0% respectively, the non-linear range of dsRNA fell into 1.56-100.00 ng·mL-1(r=0.999 3). The ELISA method showed that the recovery was 103.2% with the RSD of repeatability and intermediate precision were 19.5% and ≤11.7% respectively, the non-linear range of dsRNA fell into 7.81-500.00 ng·mL-1(r=0.999 8). The Dot Blot method showed that the recovery was 101.5% with the RSD of repeatability and intermediate precision were 18.5% and ≤42.2% respectively, the non-linear range of dsRNA fell into 800.00-80 000.00 ng·mL-1(r=0.999 2). The accuracy and precision of the HTRF and ELISA method are effective, and the HTRF method could detect lower concentrations of dsRNA residues. Conclusion: The three methods all could determine the dsRNA residues in mRNA vaccines effectively.
LIU Jing-jing, LI Yu-hua
. Comparison of three methods for detecting dsRNA residues in mRNA vaccines*[J]. Chinese Journal of Pharmaceutical Analysis, 2022
, 42(11)
: 1941
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DOI: 10.16155/j.0254-1793.2022.11.10
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