Venor® Mycoplasma dPCR
Venor® Mycoplasma dPCR enables rapid and reliable detection of
mycoplasma in cell cultures, biopharmaceutical products and ATMPs with
digital PCR.
- EP 2.6.7 (12.2) and USP <77> compliant
- Highest sensitivity on market through detection of both RNA and DNA
- Compatible with QIAcuity® digital PCR system
- Fast results in < 3 h
Product Description
Venor® Mycoplasma dPCR is a digital PCR assay
for the rapid, sensitive, and reliable detection of mycoplasma
contamination in cell cultures, cell culture-derived biologicals, and
Advanced Therapy Medicinal Products (ATMPs). The assay has specifically
been developed for use with the QIAcuity® digital PCR system and is
validated according to EP 2.6.7 (12.2), USP <77>, and in
compliance with ICH Q2(R2), meeting criteria for specificity,
robustness, and sensitivity with detection limits of ≤ 10 CFU/ml and
< 100 GC/ml.
Venor® Mycoplasma dPCR specifically detects mycoplasma by amplifying
the highly conserved 16S rRNA coding region of the mycoplasma genome.
This enables broad and reliable detection of Mollicutes, including the
species listed in the EP and USP. An integrated reverse transcription
step allows the assay to detect both mycoplasma DNA and RNA,
significantly increasing analytical sensitivity and supporting the
detection of low-level contamination.
The kit includes a positive control and an internal control. The
external positive control (EPC) / extraction inhibition control (EIC) is
not included in the kit. For this purpose, we recommend using 100GC®, 10CFU®, or 100CFU® Mycoplasma Standards.
For product-specific validation (“test for inhibitory substances” or “method suitability test”), we recommend using 100GC® or 10CFU® Mycoplasma Standards.
SDS.pdf
Specifications
| Application |
Mycoplasma detection |
| Application areas |
- QC release of biopharmaceuticals and ATMPs
- QC of cell cultures
|
| Contents |
- Mycoplasma Mix
- Positive Control
- Internal Control
- dPCR grade Water
|
| Compliance |
EP 2.6.7, USP <77>, JP18 G3 |
| Validation report |
available |
| Time-to-result |
< 3 h |
| PCR type |
Digital PCR with reverse transcription |
| Compatible devices |
QIAcuity® digital PCR device |
| Detection limit (LOD) |
≤ 10 CFU/ml
< 100 GC/ml |
| Detection spectrum |
≥ 130 mollicutes |
| Control system |
- Positive control
- Internal control
|
| Number of reactions |
- 111-0001: 24 reactions
- 111-0002: 96 reactions
|
| Price per reaction |
- 111-0001: €17.79
- 111-0002: €16.16
|
Required equipment
and consumables |
- QIAcuity® digital PCR device
- QIAcuity® Nanoplate 26k
- QIAcuity® OneStep Advanced Probe Kit
- 1.5 ml reaction tubes
- PCR tubes
- Centrifuge
- Pipettes
- Vortex mixer
- Venor® Mycoplasma Extraction
Optional for product-specific validation and as EPC/EIC: 10CFU®/100CFU®/100GC® Mycoplasma Standards
(Please refer to the manual for complete list and recommendations) |
| Storage |
2-8 °C; ≤ –18 °C after opening or rehydration |
| Shipping |
Ambient temperature |
| Shelf life (max.) |
18 months |
If you cannot find the answer to your problem then please contact us or telephone +44 (0)1954 210 200