Objective: To establish an adenovirus titer assay based on HEK293 cells using a kit method and to perform methodological validation to determine the feasibility of the method. Methods: The titer of adenovirus was detected with TaKaRa kit, and the specificity, accuracy, precision, durability and linearity of the method were verified. Results: The adjuvant components, other types of virus and heterologous anti-virus serum in the sample did not interfere with the result of virus titer determination; RSD of repeatability and reproducibility of the two samples detected by this method were both less than 20%, with the average recovery rate between 80% and 120%. There was no statistically significant difference in the results detected at different places at different times and places (P>0. 05). The linear range of viral titers for the detection of adenoviral stock solution and adenovirus finished products by the kit method was 7.15-9.88 IFU·mL-1 and 6.43-9.20 IFU·mL-1, respectively. Within the linear range, the linear regression coefficients (r) were 1.000 and 0.999 8, respectively. Conclusion: The kit method established in this experiment to detect adenovirus titer has good exclusivity, accuracy, precision, durability and linearity. It is a simple, fast method with small detection error, which can be used for the detection of adenovirus titer.
SONG Zhi-guang, WANG Bin, SHEN Zhi-qiang, MENG Qi, LIU Xin-ke, CUI Peng-cheng
. Establishment and validation of a kit method for detecting adenoviral titer[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(9)
: 1623
-1630
.
DOI: 10.16155/j.0254-1793.2023.09.20
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