The HEK293 Host Cell Residue DNA Size Analysis Kit is designed for the quantitative analysis of HEK293 residual DNA fragments of various lengths in intermediates, semi-finished products, and final products of biological preparations. This kit utilizes the qPCR fluorescence probe principle to specifically and rapidly detect HEK293 DNA residues both below and above 200 base pairs, with a quantification limit as low as 10 fg/μL. It also includes the HEK293 DNA Control (DNA quantitative reference). This kit can be used in conjunction with the company's magnetic bead-based residual DNA sample preparation kits (Cat#18461ES). Validation Report 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 limit of quantification can reach 10 fg/μL level; High precision: high intra-batch repeatability and low inter-batch variation; Strong exclusivity: specific detection of residual DNA in HEK293 cells without interference from other exogenous genomic DNA; Strong anti-interference: adding UDG enzyme, digesting routine product aerosol contamination, preventing non-specific amplification. Application Residual HEK293 Host Cell DNA Size test in biological products. Specification Sensitivity 10 fg/μL (range 30 fg/μL~300 pg/μL) Assay Time ~1.5 hours Assay Principle Fluorescent probe qPCR method Required Instruments Real-time fluorescence quantitative PCR system Components Components No. Name 41316ES70-EN 41316ES74-EN 41316-A HEK293 qPCR Mix 0.75 mL×4 1.5 mL×4 41316-B1 HEK293 Primer&Probe Mix-82 250 μL 500 μL 41316-B2 HEK293 Primer&Probe Mix-133 250 μL 500 μL 41316-B3 HEK293 Primer&Probe Mix-227 250 μL 500 μL 41316-B4 HEK293 Primer&Probe Mix-515 250 μL 500 μL 41316-C DNA Dilution Buffer 1.8 mL×2 1.8 mL×4 41316-D HEK293 DNA Control (30 ng/μL) 25 μL 50 μL Storage This product should be stored at -25~-15℃ for 2 years. Both 41316-A and 41316-B1&B2&B3&B4 all should be stored protected from light. Figures Limit of quantification The primer probes for the four fragments, 82bp, 133bp, 227bp and 515bp, were used to detect HEK293 DNA at 30fg/μL, 20fg/μL, 10fg/μL (i.e. 0.01pg/μL), with 10 replicates for each concentration, respectively. The results showed that at concentrations of 10fg/μL (i.e., 0.01pg/μL) and above, the CVs of the four fragments were