HEK293 Residual DNA Detection Kit (qPCR), BP-QN09
qPCR kit for quantitative HEK293 host-cell DNA detection.
Product overview
HEK293 Residual DNA Detection Kit (qPCR) is a 100-reaction BIORI qPCR kit for quantitative detection of HEK293 host-cell DNA in biological-product samples. It uses probe-based qPCR chemistry with an exogenous internal standard to monitor extraction and amplification. The kit includes HEK293 calibrators from 30 fg/µL to 300 pg/µL for residual DNA quantitation workflows.
Features and applications
- Targets conserved HEK293 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 HEK293 calibrators from 30 fg/µL to 300 pg/µL.
- Supports quantitative residual DNA testing across biopharmaceutical process stages.
- Designed for use with compatible real-time PCR instruments and a suitable sample nucleic acid extraction workflow.
- Quantitative detection of HEK293 host-cell DNA.
- Biopharmaceutical intermediate, semi-finished product, and finished product testing.
- Host-cell 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 |
|---|---|
| HEK293 qPCR MIX | 1.0 mL × 2 tubes |
| HEK293 Internal Standard | 1.0 mL × 1 tube |
| HEK293 Negative Control | 1.0 mL × 2 tubes |
| HEK293 Calibrator ST1 | 0.5 mL × 1 tube; 30 fg/µL |
| HEK293 Calibrator ST2 | 0.5 mL × 1 tube; 300 fg/µL |
| HEK293 Calibrator ST3 | 0.5 mL × 1 tube; 3 pg/µL |
| HEK293 Calibrator ST4 | 0.5 mL × 1 tube; 30 pg/µL |
| HEK293 Calibrator ST5 | 0.5 mL × 1 tube; 300 pg/µL |
Performance data
Performance Data
HEK293 Residual DNA Detection Kit (qPCR) Catalog No. BP-QN09-100
A product-specific validation study evaluated analytical performance for HEK293 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 0.9998 and the amplification efficiency was 100.02%.
Limit of Quantitation
Observed in this validation study: at 10 fg/μL, the mean concentration was 10.87 fg/μL, with 8.36% CV and 8.73% accuracy bias across 10 replicates.
| Replicate | Concentration value | Mean concentration | CV | Accuracy bias |
|---|---|---|---|---|
| Replicate 1 | 10.26 | 10.87 | 8.36% | 8.73% |
| Replicate 2 | 11.43 | |||
| Replicate 3 | 10.06 | |||
| Replicate 4 | 9.03 | |||
| Replicate 5 | 10.61 | |||
| Replicate 6 | 11.28 | |||
| Replicate 7 | 11.35 | |||
| Replicate 8 | 10.9 | |||
| Replicate 9 | 11.66 | |||
| Replicate 10 | 12.14 |
Recovery
HEK293 DNA at the corresponding concentrations was spiked into three actual samples. After purification using the pretreatment kit and testing with the amplification reagent, recoveries were within 70%-130%.
| Sample Name | Mean Measured Sample Value (pg/μL) | Spike Amount (pg) | Mean Measured Spiked Value (pg/μL) | Elution Volume (μL) | Recovery |
|---|---|---|---|---|---|
| Sample 1 | 2.12E-01 | 30.5 | 4.75E-01 | 100 | 86.12% |
| Sample 2 | 1.96E+00 | 305 | 5.22E+00 | 100 | 106.94% |
| Sample 3 | 2.10E+01 | 3050 | 4.93E+01 | 100 | 92.61% |
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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