CHO Residual DNA Detection Kit (qPCR), BP-QN88
Quantifies residual CHO host-cell DNA by probe-based qPCR.
Product overview
CHO Residual DNA Detection Kit (qPCR), Cat. No. BP-QN88-100, enables quantitative detection of CHO residual DNA in process intermediates, semi-finished products, and finished biological-pharmaceutical products. This fluorescent-probe-based qPCR assay is supplied with an exogenous internal standard and calibrators for residual host-cell DNA quantification.
Features and applications
- qPCR probe-based assay targeting conserved CHO genomic sequences.
- Kit includes an exogenous internal-standard for monitoring extraction and amplification performance.
- UDG enzyme is included to help prevent carry-over contamination derived from amplicons.
- Six CHO calibrators are supplied from 3 fg/μL to 300 pg/μL.
- The COA reports cover precision, accuracy, amplification efficiency, linear correlation, and internal-standard Ct results.
- Quantification of CHO residual DNA in biopharmaceutical process samples.
- Testing of intermediates, semi-finished products, and finished products.
- Compatible with qPCR workflows on real-time PCR systems listed in the product manual.
- Supports Sample Extraction Recovery Control (ERC) workflows when paired with a suitable nucleic acid extraction or purification kit.
Components
| Component | Specification |
|---|---|
| CHO qPCR MIX | 1.0 mL × 2 tubes |
| CHO Internal Standard | 1.0 mL × 1 tube |
| CHO Negative Control | 1.0 mL × 2 tubes |
| CHO Calibrator ST1 | 0.5 mL × 1 tube; 3 fg/μL |
| CHO Calibrator ST2 | 0.5 mL × 1 tube; 30 fg/μL |
| CHO Calibrator ST3 | 0.5 mL × 1 tube; 300 fg/μL |
| CHO Calibrator ST4 | 0.5 mL × 1 tube; 3 pg/μL |
| CHO Calibrator ST5 | 0.5 mL × 1 tube; 30 pg/μL |
| CHO Calibrator ST6 | 0.5 mL × 1 tube; 300 pg/μL |
Performance data
Performance Data
CHO Residual DNA Detection Kit (qPCR) Catalog No. BP-QN88-100
A product-specific validation study evaluated analytical measurement performance for CHO residual DNA. This selected upload version includes only the supported linearity and recovery results.
Key Performance at a Glance
| Performance parameter | Result |
|---|---|
| Linear range | 0.5 fg/μL to 300 pg/μL |
| Acceptance range for recovery | 70%-130% |
Linearity
Observed in this validation study: across the evaluated range of 0.5 fg/μL to 300 pg/μL, the coefficient of determination (R2) was 0.99982 and the amplification efficiency was 98.687%.
Recovery
Recovery was evaluated across four matrix-spiked samples. Observed recoveries ranged from 92.69% to 112.68% (acceptance range 70%-130%).
| Spike amount (fg) | Concentration value | Mean | Recovery | ||
|---|---|---|---|---|---|
| 3.00E+03 | 2.93E+01 | 2.49E+01 | 2.92E+01 | 2.78E+01 | 92.69% |
| 3.00E+04 | 3.10E+02 | 2.90E+02 | 2.93E+02 | 2.98E+02 | 99.21% |
| 3.00E+05 | 2.83E+03 | 3.13E+03 | 2.61E+03 | 2.86E+03 | 95.17% |
| 3.00E+06 | 3.43E+04 | 3.64E+04 | 3.07E+04 | 3.38E+04 | 112.68% |
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. |
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