This kit is designed for the quantitative detection of residual host cell DNA—specifically SV40 Large T Antigen (LTA) and Adenovirus E1A sequences—in biopharmaceutical products derived from host cells such as HEK293T. Utilizing probe-based real-time PCR (qPCR), the assay enables highly specific and rapid quantification of SV40 LTA and E1A residual DNA, with a limit of detection as low as 10¹ copies/μL. The kit is fully compatible with Yeasen’s Magnetic Bead–Based Residual DNA Sample Preparation Kits (Cat# 18461ES) for streamlined sample processing. Validated Report Features Complies with regulations – Fully validated; validation reports available. High-quality reagents – All components in-house developed; enzymes made in ultra-clean facility. Highly sensitive – Detection down to 10¹ copies/μL. Highly reproducible – Low within-run and between-run variability. Highly specific – Detects only SV40 LTA and E1A DNA—no cross-reactivity. Built-in control – Internal Control (IC) flags sample or reaction issues. Components Components No. Name 41310ES50(50 T) 41310ES60(100 T) 41310-A SV40LTA&E1A qPCR Mix 0.75 mL 1.5 mL 41310-B SV40LTA&E1A Primer&Probe Mix 200 μL 400 μL 41310-C DNA Dilution Buffer 2 × 1.8 mL 4 × 1.8 mL 41310-D SV40LTA&E1A DNA Control (nonliner) 25 μL 50 μL 41310-E SV40LTA&E1A DNA Control (linear) 25 μL 50 μL 41310-F IC 50 μL 100 μL *IC: Internal control. Storage This product should be stored at -25~-15℃ for 2 years. Both 41310-A and 41310-B should be stored protected from light. Applicable Instrument Models Include but not limited to: Bio-Rad: CFX96 Optic Module. Thermo Scientific: ABI 7500; ABI Quant Studio 5. Figures 1. Detection Range SV40LTA: Linear range = 1.8 × 10¹ ~ 1.8 × 10⁵ copies/μL, R² = 1.000, amplification efficiency = 100.25%, CV < 15% across all concentrations. E1A: Linear range = 1.8 × 10¹ ~ 1.8 × 10⁵ copies/μL, R² = 1.000, amplification efficiency = 100.25%, CV < 15% across all concentrations. Figure 1. SV40LTA standard curve (left) and amplification plot (right) Figure 2. E1A standard curve (left) and amplification plot (right) 2. Limit of Quantitation (LOQ) SV40LTA & E1A DNA at concentrations of 18, 9, 4.5, 2.25, and 1.8 copies/μL were tested in 10 replicates each. At ≥4.5 copies/μL, CVs were
