Venor® Bacteria qPCR
Product Description
Venor® Bacteria qPCR is a real-time PCR assay
for rapid detection of bacterial contamination in cell cultures, cell
culture-derived biologicals, and Advanced Therapy Medicinal Products
(ATMPs). Unlike traditional culture-based sterility testing, the assay
also detects slow growing and viable but non-culturable (VBNC) bacteria.
By targeting the highly conserved 16S rRNA coding region in the
bacterial genome, Venor® Bacteria qPCR provides highly sensitive and
reliable results in under 3 hours.
Two workflows support different applications:
- Rapid screening in research & development
- QC release testing of cell-based products and ATMPs as a fast alternative to conventional sterility testing
Specifications
| Application |
Bacteria detection |
| Application areas |
QC release testing of ATMPs or screening in R&D |
| PCR type |
Real-time PCR |
| Compliance |
EP 5.1.6, EP 2.6.27 and USP <1223> |
| Time-to-result |
< 3 hours |
| Sensitivity |
LOD: 2.5 - 99 CFU/ml depending on species; including all bacteria species listed in EP 2.6.1 and 2.6.27 |
| Detection spectrum |
95 % of Gram-positive and Gram-negative bacteria |
| Control system |
Internal Control DNA and Positive Control DNA included |
| Kit components |
- Bacteria Mix
- Internal Control DNA
- Positive Control DNA
- PCR grade Water
|
Required equipment and consumables |
- qPCR cycler (FAM™ and HEX™, alternatively VIC™/JOE™)
- 1.5 ml reaction tubes
- PCR tubes, strips or plates
- centrifuge for 1.5 ml PCR tubes
- pipettes
- vortex mixer
- extraction kit (optional)
(Please refer to the manual for complete list and recommendations) |
| Number of reactions |
- 12-2025: 25 reactions
- 12-2100: 100 reactions
|
| Price per reaction |
- 12-2025: €11.36
- 12-2100: €10.80
|
| Storage |
2-8 °C; ≤ –18 °C after rehydration |
| Shipping |
Ambient temperature |
| Shelf life (max.) |
18 months |
Minerva Biolabs offers a free sample of this product for testing:
Downloads
Regulatory Disclaimer
For research and industrial use only. Not for diagnostic or therapeutic use.
If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200