Plasmid DNA Residue Detection Kit (qPCR), BP-QN120
qPCR kit for quantitative plasmid DNA residue detection.
Product overview
Plasmid DNA Residue Detection Kit (qPCR) is a 100-reaction BIORI qPCR kit for quantitative detection of plasmid DNA residues in biological-product samples. It targets consensus plasmid sequences with probe-based qPCR chemistry and includes an exogenous internal control. Linearized plasmid calibrators from 5×10¹ to 5×10⁶ copies/µL support quantitative residual DNA workflows.
Features and applications
- Targets consensus plasmid sequences using probe-based qPCR chemistry.
- Includes an exogenous internal control to monitor extraction and amplification.
- Contains UDG to help prevent contamination from amplification products.
- Supplied as a 100 Reactions/Kit format.
- Includes linearized plasmid calibrators from 5×10¹ to 5×10⁶ copies/µL.
- The COA reports cover precision, accuracy, amplification efficiency, linear correlation, and internal-control Ct results.
- Designed for quantitative residual plasmid DNA testing rather than endpoint presence/absence screening.
- Supports workflows that combine sample extraction, internal-control monitoring, and qPCR quantitation.
- Quantitative detection of plasmid DNA residues.
- Biological-product sample testing.
- Residual plasmid impurity analysis during bioprocess development and quality analysis.
- qPCR workflows using supported real-time PCR instruments.
- Extraction and recovery-control workflows with a suitable nucleic acid extraction kit.
Components
| Component | Specification |
|---|---|
| Plasmid qPCR MIX | 1.0 mL × 2 tubes |
| Plasmid Internal Control | 1.0 mL × 1 tube |
| Plasmid Negative Control | 1.0 mL × 2 tubes |
| Plasmid Calibrator ST1 | 0.5 mL × 1 tube; 5×10¹ copies/µL |
| Plasmid Calibrator ST2 | 0.5 mL × 1 tube; 5×10² copies/µL |
| Plasmid Calibrator ST3 | 0.5 mL × 1 tube; 5×10³ copies/µL |
| Plasmid Calibrator ST4 | 0.5 mL × 1 tube; 5×10⁴ copies/µL |
| Plasmid Calibrator ST5 | 0.5 mL × 1 tube; 5×10⁵ copies/µL |
| Plasmid Calibrator ST6 | 0.5 mL × 1 tube; 5×10⁶ copies/µL |
Performance data
Performance Data
Plasmid DNA Residue Detection Kit (qPCR) Catalog No. BP-QN120-100
A product-specific validation study evaluated analytical measurement performance for plasmid residual DNA. This selected upload version includes only the supported linearity and recovery results.
Key Performance at a Glance
| Performance parameter | Result |
|---|---|
| Linear range | 1.00E+01 copies/μL to 5.00E+06 copies/μL |
| Acceptance range for recovery | 70%-130% |
Linearity
Observed in this validation study: across the evaluated range of 1.00E+01 copies/μL to 5.00E+06 copies/μL, the coefficient of determination (R2) was 0.99982 and the amplification efficiency was 98.620%.
Recovery
Recovery was evaluated across three matrix-spiked samples. Observed recoveries ranged from 97.64% to 104.43% (acceptance range 70%-130%).
| Spiked sample | Concentration value | Mean | Recovery |
|---|---|---|---|
| ERC-ST3 | 4.90E+02 | 4.88E+02 | 97.64% |
| 4.86E+02 | |||
| ERC-ST4 | 5.07E+03 | 4.98E+03 | 99.69% |
| 4.90E+03 | |||
| ERC-ST5 | 5.46E+04 | 5.22E+04 | 104.43% |
| 4.98E+04 |
Performance data shown here were obtained with the reference materials, extraction workflows, instruments and acceptance criteria used in BIORI’s product-specific validation study. Users should verify performance in their own sample matrix and workflow.
Shipping and storage
| Condition | Recommendation |
|---|---|
| Storage | Store protected from light at <= -20°C. Validity period: 24 months. |
| Shipping | Ship frozen or under validated cold-chain conditions that maintain frozen storage. |
| Handling | Avoid repeated freeze-thaw cycles; do not exceed 10 freeze-thaw cycles. |
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