E. coli Residual DNA Detection Kit (qPCR), BP-QN24, provides quantitative detection of E. coli residual DNA in intermediates, semi-finished products, and finished biological or pharmaceutical products. The fluorescent probe qPCR workflow includes an internal standard and calibrators for residual host-cell DNA testing.
E.coli Residual DNA Detection Kit (qPCR), BP-QN24
Product information published by Zhuhai Biori Biotechnology Co., Ltd.
Features
- qPCR probe-based assay targeting conserved E.coli genomic sequences.
- Includes an exogenous internal standard for extraction and amplification monitoring.
- UDG enzyme is included to help prevent carryover contamination from amplification products.
- Five E.coli calibrators are supplied from 30 fg/uL to 300 pg/uL.
- COA reports conforming precision, accuracy, amplification efficiency, linear correlation, and internal-standard Ct results.
Application
- Quantification of E.coli residual DNA in biopharmaceutical process samples.
- Testing of intermediates, semi-finished products, and finished products.
- qPCR workflows using supported real-time PCR systems listed in the manual.
- Sample ERC workflows when paired with a suitable nucleic acid extraction or purification kit.
Components
| Component | Specification |
|---|---|
| E.coli qPCR MIX | 1.0 mL x 2 tubes |
| E.coli Internal Standard | 1.0 mL x 1 tube |
| E.coli Negative Control | 1.0 mL x 2 tubes |
| E.coli Calibrator ST1 | 0.5 mL x 1 tube; 30 fg/uL |
| E.coli Calibrator ST2 | 0.5 mL x 1 tube; 300 fg/uL |
| E.coli Calibrator ST3 | 0.5 mL x 1 tube; 3 pg/uL |
| E.coli Calibrator ST4 | 0.5 mL x 1 tube; 30 pg/uL |
| E.coli Calibrator ST5 | 0.5 mL x 1 tube; 300 pg/uL |
Shipping and Storage
| Condition | Recommendation |
|---|---|
| Storage | <= -20 C, protected from light. Shelf life: 24 months. Avoid more than 10 freeze-thaw cycles. |
| Shipping | Ship frozen on dry ice or with validated frozen cold-chain packaging that maintains the specified frozen storage condition. |
| Handling | Protect from light and avoid unnecessary freeze-thaw cycles where applicable. |
Data
Performance Data
E. coli Residual DNA Detection Kit (qPCR) | Catalog No. BP-QN24-100
A product-specific validation study evaluated analytical measurement performance for E. coli residual DNA. This upload version highlights the linear range, quantitation limit, detection limit, and recovery results.
Key Performance at a Glance
| Perf |
Sele |
|---|---|
| Line |
5 fg/ |
| Limi |
5 fg/ |
| Limi |
1 fg/ |
| Reco |
70%- |
Linearity
Observed in this validation study: across the evaluated range of 5 fg/μL to 300 pg/μL, the correlation coefficient was 0.99982 and amplification efficiency was 99.26%.
Limit of Quantitation
Observed in this validation study: at 5 fg/μL, the mean concentration was 4.71E+00 fg/μL, with 12.40% CV and 5.70% accuracy bias across 10 replicates.
| Repl |
Conc |
Mean conc |
CV | Accu |
|---|---|---|---|---|
| Repl |
5.72 |
4.71 |
12.40% | 5.70% |
| Repl |
4.47 |
|||
| Repl |
4.62 |
|||
| Repl |
4.50 |
|||
| Repl |
4.11 |
|||
| Repl |
5.76 |
|||
| Repl |
4.85 |
|||
| Repl |
4.38 |
|||
| Repl |
4.59 |
|||
| Repl |
4.14 |
Recovery
Recovery was evaluated across four spiked samples. Observed in this validation study: recovery values in the selected table ranged from 79.75% to 90.41%.
| Samp |
Mean samp |
Spik |
Mean spik |
Elut |
Reco |
|---|---|---|---|---|---|
| Samp |
1.4754 |
30 | 3.8680 |
100 | 79.75% |
| Samp |
1.2359 |
300 | 3.7714 |
100 | 84.52% |
| Samp |
1.1642 |
3000 | 3.7454 |
100 | 86.04% |
| Samp |
1.2560 |
3000 | 1.5272 |
100 | 90.41% |
Study Scope and Limitations
Results apply to the reference materials, sample preparation, instruments, and conditions used in this product-specific validation study. Direct-dilution data are intentionally not included in this selected upload version. Users should verify suitability with their own sample matrix and workflow.
