RCL Gene Copy Number Detection Kit (qPCR), BP-QN10
qPCR kit for RCL copy-number detection in lentiviral-vector products.
Product overview
This kit adopts the PCR-fluorescent probe method, with primers and probes designed for the VSV-G gene. It uses ready-to-use calibrators prepared by serial dilution after digital PCR quantification, enabling accurate quantification of RCL copy numbers in cell and gene therapy products.
Features and applications
- Designed for quantitative detection of replication-competent lentivirus (RCL).
- Targets the VSV-G gene using probe-based qPCR chemistry.
- Uses ready-to-use calibrators prepared by serial dilution after digital PCR quantification.
- Includes an internal control to monitor extraction and amplification abnormalities.
- Contains UDG to help prevent carryover contamination from amplification products.
- Supports RCL copy-number assessment in products produced with lentiviral-vector systems.
- RCL copy-number detection in cell therapy products.
- RCL testing in gene therapy products produced by lentiviral vectors.
- Vector safety and quality analysis workflows.
- In-process or release-support testing for lentiviral-vector product development.
- qPCR workflows using supported real-time PCR instruments.
Components
| Component | Specification |
|---|---|
| RCL qPCR MIX 1 | 0.9 mL × 2 tubes |
| RCL qPCR MIX 2 | 0.2 mL × 1 tube |
| RCL Negative Control | 1.0 mL × 2 tubes |
| RCL Calibrator ST1 | 0.5 mL × 1 tube (1×10¹ copies/μL) |
| RCL Calibrator ST2 | 0.5 mL × 1 tube (1×10² copies/μL) |
| RCL Calibrator ST3 | 0.5 mL × 1 tube (1×10³ copies/μL) |
| RCL Calibrator ST4 | 0.5 mL × 1 tube (1×10⁴ copies/μL) |
| RCL Calibrator ST5 | 0.5 mL × 1 tube (1×10⁵ copies/μL) |
| RCL Calibrator ST6 | 0.5 mL × 1 tube (1×10⁶ copies/μL) |
Performance data
Performance Data
RCL Gene Copy Number Detection Kit (qPCR) Catalog No. BP-QN10-100
A product-specific validation study evaluated analytical sensitivity, quantitation, linearity, and recovery for the RCL Gene Copy Number Detection Kit. The selected data below focus on results that are most useful for product evaluation.
Key Performance at a Glance
| Performance parameter | Result |
|---|---|
| Limit of Detection (LOD) | 0.15 copy/μL |
| Limit of Quantitation (LOQ) | 1.5 copies/μL |
| Linear range | 1.5 to 7.00E+06 copies/μL |
| Linearity and amplification criteria | R2 > 0.99; amplification efficiency 90%–110% |
| Acceptance range for recovery | 70%-130% |
Limit of Detection
Observed in this validation study: all 24 replicates were detected at each evaluated concentration from 1 copy/μL down to 0.15 copies/μL.
| Sample concentration | Detection rate |
|---|---|
| 1 copy/μL | 24/24 |
| 0.5 copy/μL | 24/24 |
| 0.2 copy/μL | 24/24 |
| 0.15 copy/μL | 24/24 |
Linearity
Observed in this validation study: the linear range was 1.5 to 7.00E+06 copies/μL, with R² = 0.99950 and amplification efficiency of 100.142%.
Recovery
Recovery was evaluated with automated and manual extraction workflows. Observed in this validation study: values in the selected table ranged from 94% to 117%.
| Extraction method | Sample | Test result | Mean concentration | Recovery | ||
|---|---|---|---|---|---|---|
| Automated extraction | ERC-ST2 | 9.96E+00 | 8.71E+00 | 1.21E+01 | 1.03E+01 | 103% |
| ERC-ST3 | 1.18E+02 | 9.01E+01 | 1.13E+02 | 1.07E+02 | 107% | |
| ERC-ST4 | 1.11E+03 | 1.13E+03 | 1.13E+03 | 1.12E+03 | 112% | |
| ERC-ST5 | 1.17E+04 | 1.09E+04 | 1.04E+04 | 1.10E+04 | 110% | |
| ERC-ST6 | 1.18E+05 | 1.21E+05 | 1.12E+05 | 1.17E+05 | 117% | |
| Manual extraction | ERC-ST2 | 8.62E+00 | 9.53E+00 | 9.95E+00 | 9.37E+00 | 94% |
| ERC-ST3 | 1.05E+02 | 1.04E+02 | 1.09E+02 | 1.06E+02 | 106% | |
| ERC-ST4 | 1.09E+03 | 1.12E+03 | 1.08E+03 | 1.10E+03 | 110% | |
| ERC-ST5 | 1.06E+04 | 1.12E+04 | 1.05E+04 | 1.08E+04 | 108% | |
| ERC-ST6 | 1.10E+05 | 1.19E+05 | 1.12E+05 | 1.14E+05 | 114% | |
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 | ≤-20 °C, protected from light. Shelf life: 24 months. Avoid more than 10 freeze-thaw cycles. |
| Shipping | Transport with ice pack cold chain packaging and keep the required frozen storage conditions. |
| Handling | Protect reagents from light and avoid unnecessary freeze-thaw cycles. |
Downloads
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