- Time-to-result: < 3 hours
- QC release testing of ATMPs and other short-shelf life products
- Detects 95 % of bacteria including VBNCs
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.
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) |
| Storage |
2-8 °C; ≤ –18 °C after rehydration |
| Shipping |
Ambient temperature |
| Shelf life (max.) |
18 months |
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