The RCA (E1A) Copynumber Detection Kit can be used to quantitatively analyze and detect the potential risk of Replication-competent Adenoviruses (RCA) that may occur in a variety of cellular therapeutic products and gene therapy products associated with the use of adenoviral vectors; and can also be used to quantitatively analyze and detect the presence of residual DNA of the risk gene E1A in biologics from host cells, such as HEK293 and HEK293T cell-derived risk gene E1A residual DNA. This kit designs specific primers for the E1A gene sequence on adenovirus, and adopts the principle of fluorescence quantitative PCR by probe method to rapidly and specifically detect the risk of replicative adenovirus RCA and the residual DNA of E1A from the host cell, and the limit of quantification can be as low as 4.1 copies/μL, and it contains the RCA (E1A) DNA Control (DNA quantitative reference product). The kit needs to be used together with the the Residual DNA Sample Preparation Kit (Cat# 18461ES). Feature Compliance with regulations: the products are fully validated according to the requirements of Chp, USP, ICH, etc., and their performance is in line with Chinese and foreign regulations and standards; Guarantee of quality: the raw materials of the kits are all self-developed, and the qPCR Mix and other enzyme products are produced in an ultra-clean enzyme factory; High sensitivity: the lower limit of quantification (LLOQ) was 4.1 copies/uL; High precision: high intra-batch reproducibility CV
