Venor®GeM qEP

Venor® kity sú detekčné kity pre rýchle a spoľahlivé testovanie prítomnosti mykoplazmy v bunkových kultúrach a biofarmaceutických produktoch. Vysoká robustnosť, citlivosť a špecificita s jednoduchým protokolom. Kity sú kompatibilné pre akýkoľvek PCR a qPCR prístroj a sú určené pre výskumné ako aj pre priemyselné laboratóriá. K dispozícii sú 4 varianty kitov s rôznymi stupňami validácie a technických konfigurácií.

Venor®GeM-qEP je detekčný qPCR kit pre vysoko kvalitné a spoľahlivé monitorovanie kontaminácie mykoplazmou. Kompletný qPCR master mix určený pre priamu detekciu bunkových kultúr ako aj pre autológne bunkové transplantáty, séra, kultivačné médiá a terapeutické protilátky. Kit je validovaný podľa European Pharmacopoeia EP2.6.7. pre „Mykoplazmy“.

100 testov

Venor®GeM qEP utilizes quantitative, real-time PCR (qPCR). The kit can be performed with any type of real-time PCR cycler able to detect the fluorescence dyes FAM™ and HEX™. The protocol provided is preferred for fast and reliable screening of cell culture supernatants most applicable in research and development. The detection procedure can be performed within 3 hours.

Mycoplasmas 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).The kit includes primer and FAM™ labeled probes which allow the specific detection of all Mollicutes species so far described as contaminants of cell cultures and media components. Eukaryotic DNA is not amplified by this primer/probe system.
False negative results due to PCR inhibitors or improper DNA extraction are detected by the internal amplification control which can be added to the PCR master mix. The amplification of the internal amplification control is detected at 610 nm (HEX™ channel).

Type of PCR

Probe assay for qPCR

Recommended Use / Scope

Venor®GeM qEP is used for direct detection of Mollicutes (Mycoplasma, Acholeplasma, Spiroplasma) contamination in cell cultures and cell media components.

Kit Components

lyophilized primer/nucleotide/probe/polymerase/mix in aliquots of 25 tests
rehydration buffer

lyophilized internal amplification control
lyophilized positive control
PCR grade water

Package Sizes

• Cat. No. 11-9025 25 tests
• Cat. No. 11-9100 100 tests
• Cat. No. 11-9250 250 tests

Result Evaluation

cycler based, real-time PCR

Required Consumables

PCR reaction tubes
Optional für Prozessvalidierung und EP 2.6.7 konforme Testung:
Internal Control DNA extra (4 Röhrchen für jeweils 300 µl Interne Amplifikationskontrolle; Bestellnr. 11-9905)
10CFU™ Sensitivity Standards, verfügbar für alle in der EP 2.6.7 aufgeführten Mykoplasmenspezies

Required Lab Devices

qPCR cycler with FAM™ and ROX™ filter
variable microliter pipettes
benchtop centrifuge for 1.5 ml reaction tubes

Shelf Life and Storage

Components can be stored at +2 to +8 °C for at least 12 months. After rehydratisation the reagents must be stored at -18 °C.

EP 2.6.7 Compliance

Yes.

Please note that validation data are provided for information purpose only. EP 2.6.7 clearly states “Where commercial kits are used …, documented validation points already covered by the kit manufacturer can replace validation by the user. Nevertheless, the performance of the kit with respect to its intended use has to be demonstrated by the user (e.g. detection limit, robustness, cross-detection of other classes of bacteria.”. Please feel free to contact us if you need further assistance.

Fig. Amplified dilution series of Mycoplasma fermentans, performed on a
Corbett RotorGene®6000.