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Data Microsart AMP Mycoplasma SM-2011-e - 2 Pages

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Data Microsart AMP Mycoplasma SM-2011-e

Catalog excerpts

Microsart AMP Mycoplasma Rapid Real-time PCR Mycoplasma Detection Kit Maximum reliability – performance proved in validation and proficiency tests Highest flexibility – different protocols for various sample materials High stability – reagents lyophilized in aliquots Real-time PCR kit for the specific and sensitive detection of Mycoplasma DNA Working Principle A standard DNA extraction followed by a T ­ aqMan® probe real-time qPCR is used for the detection of Mycoplasma DNA. 200 µl to 18 ml sample volume can be used as starting material for the DNA preparation. The i ­solated DNA is amplified in a qPCR cycler and the evaluation can be performed with the standard cycler software. Introduction Microsart AMP Mycoplasma enables a reliable and sensitive detection of Mycoplasma DNA. The test procedure is successfully validated for sensitivity, specificity and robustness according to EP 2.6.7. The volume range of up to 18 ml ensures highest sensitivity. Carefully selected primer/probe combinations are h ­ ighly specific for a region within the 16S rRNA gene of more than 70 Mycoplasma s ­ pecies. The performance of the kit has been demonstrated in independent laboratories. Applications The Microsart AMP Mycoplasma kit is s ­ pecifically designed for microbiological QC labs in the bio-pharmaceutical industry or contract labs performing Mycoplasma c ­ ontamination in-process controls and | or lot release testing according to EP 2.6.7. It is used for direct detection of Mollicutes (Mycoplasma, ­ choleplasma, Spiroplasma) in A cell cultures, cell culture media components and derived biologicals. Sample types: – Master cell banks – Working cell banks – Virus seed lots – Virus harvests – Final lots of biologicals produced by cells High Performance The Microsart AMP Mycoplasma has been developed for EP compliant Mycoplasma t ­ esting. A detection limit of less than 10 cfu/ml for all Mycoplasma species mentioned in the European Pharmacopoeia fulfills the requirements for the needed sensitivity. Fast Results The Microsart AMP Mycoplasma is a fast r ­ eal-time PCR kit. The total procedure from DNA extraction to PCR result takes only a few hours. TaqMan® Probes The use of TaqMan® probes adds specificity to the PCR detection system. The analysis is performed during the cycling process – no melting curve analysis is needed. Flexible Sample Volumes With a volume range from 200 µl to 18 ml the Microsart AMP Mycoplasma offers highest flexibility for optimal results. A simple concentration step using the Sartorius Vivaspin 6 or 20 spin columns is an option for all users who need highest sensitivity. Contamination Prevention The kit contains dUTP instead of dTTP, so the option is available to degrade amplicons from previous analyses by use of uracil-DNA glycosylase (UNG). Thus the occurrence of falsepositive results can be minimized. UNG is not included in the kit. Summary For all QC labs performing European Pharmacopoeia compliant Mycoplasma testing for in-process control and lot release Sartorius offers the Microsart AMP Mycoplasma qPCR kit. It ensures highest flexibility in sample v ­ olume and ­ reparation and can be used with p all common real-time cyclers.

 Open the catalog to page 1

Typical Sampling Steps For Mycoplasma Testing Media Preparation Fermentation Working Cell Bank Seed Culture Technical specifications Each kit contains reagents for 25 or 100 reactions. The expiry date of the unopened package is specified on the package label. The kit components are to be stored until use at +2 to +8°C and must be stored after opening and rehydration below –18°C. The lot specific Certificate of Analysis can be downloaded from the manufacturer’s website (www.minerva-biolabs.com). Kit Component Rehydration Buffer Positive Control Internal Control Microsart AMP Coating Buffer...

 Open the catalog to page 2

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