Venor®GeM Classic

Venor®GeM Classic allows fast (ca. 3 hours), reliable and time-saving routine monitoring of mycoplasma contamination in cell culture supernatants by conventional PCR.
All Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) species so far described as contaminants of cell cultures and media components are specifically detected by amplifying a highly conserved rRNA operon, or more specifically, the 16S rRNA coding region in the mycoplasma genome. The mycoplasma-specific amplification is detected at 265-278 bp. False negative results due to PCR inhibitors or improper DNA extraction can be ruled out by using the provided internal amplification control (Internal Control DNA), which should be detected at 191 bp.

Type of PCR

For conventional, endpoint PCR with gel electrophoresis

Recommended Use

Applicable in research and industry for direct testing of cell cultures and biologicals. Intended for research use only. Not recommended for clinical diagnostics.

Kit Components

Lyophilized Mix: Primer sets, nucleotides and polymerase in aliquots of 25 reactions each

• 10x Reaction Buffer
• Lyophilized Positive Control DNA
• Lyophilized Internal Control DNA
• PCR Grade Water

Package Sizes

• Cat. No. 11-1025G 25 Reactions
• Cat. No. 11-1100G 100 Reactions
• Cat. No. 11-1250G 250 Reactions

Result Evaluation

Gel electrophoresis at endpoint of PCR

Required Consumables

• CR reaction tubes
• Optional for process validation and EP 2.6.7 / JP G3 compliant testing:
• Internal Control DNA extra (4 vials for 300 µl each of internal amplification control; Cat. No. 11-1905).
• 10CFU™ Sensitivity Standards available for all EP/JP listed mycoplasma species.

Required Lab Devices

• PCR cycler for conventional PCR
• Agarose gel electrophoresis and DNA staining system
• Pipetting equipment
• Tube centrifuge

Shelf Life and Storage

Store the unopened components at +2 °C to +8 °C until the expiry date indicated on the label. Once rehydrated, the components must be stored at ≤ -18 °C.

EP 2.6.7 / JP G3 compliance

Use of Venor®GeM Classic for QA testing of biologicals like master and working cell banks, autologous cells, culture media, bulk harvest and final product testing according to EP 2.6.7 and JP G3 is applicable after appropriate sample preparation and process validation.

Fig. Amplified PCR products are visualized by standard gel electrophoresis.