Human Residual DNA Detection Kit (qPCR), BP-QN54
qPCR kit for quantitative human host-cell DNA detection.
Product overview
Human Residual DNA Detection Kit (qPCR) is a 100-reaction BIORI qPCR kit for quantitative detection of human host-cell DNA in biological-product samples. It uses probe-based qPCR chemistry with an exogenous internal standard to monitor extraction and amplification. Human calibrators from 30 fg/µL to 300 pg/µL support residual DNA quantitation in biopharmaceutical testing workflows.
Features and applications
- Targets conserved human genomic sequences using probe-based qPCR chemistry.
- Includes an exogenous internal standard to monitor extraction and amplification.
- Contains UDG to help prevent carryover contamination from amplification products.
- Supplied as a 100 Reactions/kit format.
- Includes human calibrators from 30 fg/µL to 300 pg/µL.
- Supports quantitative host-cell DNA impurity testing across biopharmaceutical process stages.
- Designed for compatible real-time PCR workflows with suitable sample nucleic acid extraction.
- Quantitative detection of human host-cell DNA.
- Biopharmaceutical intermediate, semi-finished product, and finished product testing.
- Human residual DNA impurity testing during process development and quality analysis.
- Residual DNA qPCR workflows using supported real-time PCR instruments.
- Extraction and recovery-control workflows with a suitable nucleic acid extraction kit.
Components
| Component | Specification |
|---|---|
| Human qPCR MIX | 1.0 mL × 2 tubes |
| Human Internal Standard | 1.0 mL × 1 tube |
| Human Negative Control | 1.0 mL × 2 tubes |
| Human Calibrator ST1 | 0.5 mL × 1 tube; 30 fg/µL |
| Human Calibrator ST2 | 0.5 mL × 1 tube; 300 fg/µL |
| Human Calibrator ST3 | 0.5 mL × 1 tube; 3 pg/µL |
| Human Calibrator ST4 | 0.5 mL × 1 tube; 30 pg/µL |
| Human Calibrator ST5 | 0.5 mL × 1 tube; 300 pg/µL |
Performance data
Performance Data
Human Residual DNA Detection Kit (qPCR) Catalog No. BP-QN54-100
A product-specific validation study evaluated analytical performance for human residual DNA. This released version presents data for linear range, limit of quantitation, and recovery.
Key Performance at a Glance
| Performance parameter | Selected result |
|---|---|
| Linear range | 10 fg/μL to 300 pg/μL |
| Limit of Quantitation (LOQ) | 10 fg/μL |
| Acceptance range for recovery | 70%-130% |
Linearity
Observed in this validation study: across the evaluated range of 10 fg/μL to 300 pg/μL, the coefficient of determination (R2) was 0.9997 and the amplification efficiency was 98.467%.
Limit of Quantitation
Observed in this validation study: at 10 fg/μL, the mean concentration was 10.84 fg/μL, with 7.92% CV and 8.47% accuracy bias across 10 replicates.
| Replicate | Concentration value | Mean concentration value | CV | Accuracy bias |
|---|---|---|---|---|
| Replicate 1 | 10.91 | 10.84 | 7.92% | 8.47% |
| Replicate 2 | 11.38 | |||
| Replicate 3 | 10.16 | |||
| Replicate 4 | 10.60 | |||
| Replicate 5 | 12.40 | |||
| Replicate 6 | 11.71 | |||
| Replicate 7 | 10.60 | |||
| Replicate 8 | 9.87 | |||
| Replicate 9 | 10.23 | |||
| Replicate 10 | 10.60 |
Recovery
Samples were spiked with 30.5 pg, 305 pg, and 3,050 pg of human DNA (elution volume 100 μL). After purification using the pretreatment kit and testing with the amplification kit, the recovery of each simulated sample was within 70%-130%.
| Sample 1 | Sample 2 | Sample 3 | |
|---|---|---|---|
| Replicate 1 | 2.80E-01 | 3.07E+00 | 2.73E+01 |
| Replicate 2 | 3.38E-01 | 3.20E+00 | 2.67E+01 |
| Replicate 3 | 3.24E-01 | 2.86E+00 | 2.69E+01 |
| Mean (pg/μL) | 3.14E-01 | 3.04E+00 | 2.70E+01 |
| Spike Amount (pg) | 30.5 | 305 | 3050 |
| Elution Volume (μL) | 100 | 100 | 100 |
| Recovery | 102.95% | 99.67% | 88.52% |
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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