Описание
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.
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 <20%, establishing the LOQ as 4.5 copies/μL.
Figure 3. qPCR detection of SV40LTA(lift) and E1A(right) at 4.5 copies/μL
|
Replicate Analyte |
SV40LTA (copies/μL) |
E1A (copies/μL) |
||
|
Quantity |
Recovery |
Quantity |
Recovery |
|
|
1 |
4.66 |
103.61% |
4.87 |
108.21% |
|
2 |
4.33 |
96.29% |
4.15 |
92.26% |
|
3 |
4.49 |
99.72% |
4.63 |
102.88% |
|
4 |
5.08 |
112.97% |
4.86 |
107.99% |
|
5 |
6.26 |
139.11% |
5.67 |
125.93% |
|
6 |
5.46 |
121.26% |
4.97 |
110.42% |
|
7 |
4.79 |
106.34% |
5.50 |
122.22% |
|
8 |
5.57 |
123.83% |
5.00 |
111.20% |
|
9 |
5.09 |
113.18% |
5.55 |
123.28% |
|
10 |
4.62 |
102.62% |
4.97 |
110.43% |
|
Mean |
5.04 |
\ |
5.02 |
\ |
|
CV% |
11.73% |
\ |
9.13% |
\ |
Documents:
Safety Data Sheet
Manuals
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Расследование
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