Venor®GeM qEP

Venor®GeM qEP

Description

Venor®GeM qEP utilizes quantitative, real-time PCR (qPCR) for fast (ca. 3 h) and reliable screening of cell culture supernatants for mycoplasma contaminations. The kit can be used in combination with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and HEX™.
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 520 nm (FAM™ channel). False negative results due to PCR inhibitors or improper DNA extraction can be ruled out by using the provided internal amplification control, which is detected at 610 nm (HEX™ channel).

Recommended Use

Applicable in research and industry for the direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) contaminations in cell cultures and biopharmaceuticals. For testing according to EP 2.6.7, USP <71> and JP G3.

Kit Components

Lyophilized Mix: Primer sets / Nucleotides/ Probes / Polymerase in aliquots of 25 reactions each
Rehydration Buffer
Lyophilized Internal Control DNA
Lyophilized Positive Control
PCR Grade Water

Required Consumables

PCR 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. 11-9905)
10CFU™ Sensitivity Standards available for all EP 2.6.7 / JP G3 listed Mycoplasma species

Required Lab Devices

qPCR cycler with FAM™ and HEX™ filter
Pipetting equipment
Benchtop centrifuge for 1.5 ml reaction tubes

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.