Venor®GeM Classic

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 Classic je základný detekčný PCR kit pre priame, spoľahlivé a časovo nenáročné monitorovanie kontaminácie mykoplazmou. Detekcia až 1,5 kópie/ ml mykoplazmatickej DNA zodpovedajúcej 3 mykoplazmám/ vzorku (LOD95%=4,5 kopie/ml). Špecifický pre viac ako 25 druhov mykoplaziem.

Kit je validovaný podľa European Pharmacopoeia EP2.6.7. pre „Mykoplazmy“. Balenie neobsahuje polymerázu.

50 testov

Venor®GeM Classic allows fast, reliable and time-saving routine monitoring of mycoplasma contamination by PCR.

Type of PCR

For conventional, endpoint PCR

Recommended Use / Scope

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 primer sets and nucleotides
10x reaction buffer optimized for MB Taq DNA Polymerase
Lyophilized positive control DNA
Lyophilized internal amplification control

Package Sizes

Primer sets and nucleotides are prepared in aliquots of 25 tests.

• Cat. No. 11-1025 25 Tests
• Cat. No. 11-1050 50 Tests
• Cat. No. 11-1100 100 Tests
• Cat. No. 11-1250 250 Tests

Result evaluation

Gel electrophoresis at endpoint of PCR

Required Consumables

Polymerase. We highly recommend our reliable hot-start MB Taq DNA Polymerase, Cat.-No. 53-0050/100/200/250. PCR reaction tubes

Optional for process validation and EP 2.6.7 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 listed mycoplasma species

Required lab devices

Regular PCR cycler
Agarose gel electrophoresis and DNA staining system
Pipetting equipment
Tube centrifuge

Shelf Life and Storage

Components are maintainable at +2 to +8 °C for at least 6 months. After rehydratisation the reagents must be stored at -18 °C.

EP 2.6.7 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 is applicable after appropriate sample preparation and process validation.

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