Mycoplasma Detection Kit
CytoInspect™/CytoInspect™ DNA Extraction Kit

Mycoplasma contamination during biopharmaceutical manufacture is a significant threat to the production of high-quality biotechnological products. Contamination with mycoplasmas, the smallest known class of self-replicating microorganisms, can both compromise final product safety and reduce product yields. CytoInspect™ is a premium test kit for the identification of mycoplasma species in cell cultures and other biological materials. It has been validated under GMP conditions in accordance with the guidelines of the European Pharmacopoeia.

CytoInspect™ detects mycoplasma species with a universal mycoplasma probe (including Acholeplasma sp., Spiroplasma sp. and Ureaplasma sp.) and identifies 40 individual species using species-specific probes. Species determination can help to identify the contamination source. Thereby it prevents a further spread of an infection. DNA is first extracted from a sample using the proprietary CytoInspect™ DNA Extraction Kit which specifically enriches mycoplasma DNA from various background matrices with up to 109 cells/ml and for sample volumes of up to 50 ml. PCR is performed on the extracted material. The PCR primers amplify conserved, mycoplasma-specific sequences of the 16S - 23S rRNA intergenic transcribed spacer of mycoplasma DNA. dUTP is incorporated into the CytoInspectTM PCR mastermix enabling treatment of PCR reactions with uracil-N-glycosylase thereby minimising the risk of cross-contamination with amplicons from previous PCR reactions. The fluorescently-labelled, amplified DNA fragments are then hybridised to the HTA™Slide* (microarray chip). The chip contains probes for both species-specific targets and a universal probe detecting any species of mycoplasma present in the original sample. The CytoInspect™ chip also integrates a comprehensive range of controls, allowing monitoring of the entire assay. Finally, the Check Scanner™ and the Check Report™Software are used for the detection of any bound, fluorescent PCR products. The CytoInspect™ DNA chip has a total of 225 individual measurement points which are first scanned by the CheckScanner™ and subsequently automatically analysed using the CheckReport™ Software. The software enables automatic sample tracking, rapid report generation and digital data management . The CheckReport™ Software fully complies with the FDA 21 CFR part 11 for electronic records. With results delivered in 5 hours, CytoInspect™ is a rapid and effective alternative to culture-based mycoplasma assays. The assay shows superior sensitivity and specificity to traditional mycoplasma detection tests. CytoInspect™ is part of a complete assay system, consisting of the CytoInspect™ kit, the CytoInspect™ DNA Extraction Kit, the CheckScanner™and the CheckReport™ Software. CytoInspect™ is a ready-to-use kit and includes the CytoInspect™ DNA chips, the PCR mastermix, buffers and a detailed instruction manual. The CytoInspect™ DNA Extraction Kit contains all necessary reagents for sample DNA extraction

464 060
CytoInspect™ identification of
mycoplasma species
Test per case
on request