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primary topic: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics

A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics
type: AcademicArticle
type: Article
abstract: BACKGROUND: Contamination of cell culture and biological material by mollicute species is an important safety issue and requires testing. We have developed a singletube real-time polymerase chain reaction (PCR) assay for rapid detection of Mollicutes species stipulated by the European Pharmacopeia. METHODS: Primers and TaqMan probes (FAM- abeled) were deduced from 16S rDNA sequence alignment of 18 mollicutes species. A synthetic internal control (IC) DNA and an IC-specific TaqMan probe (VIC-labeled) were included. The analytical sensitivity of the assay was determined on DNA dilutions from 12 mollicute strains. Specificity was proven by the use of DNA from other bacteria. RESULTS: Analytical sensitivities of the PCR assay were in the range of 405–2,431 genomes/ml for 11 of the 12 tested mollicute DNA samples. The lowest sensitivity was found for Ureaplasma urealyticum (19,239 genomes/ml). Negative results for DNA samples from 3 different ubiquitous bacteria demonstrated the specificity of the PCR assay for Mollicutes. Direct testing of cell culture supernatants spiked with Mycoplasma orale revealed similar sensitivity compared to isolated DNA. CONCLUSION: Our single-tube real-time PCR assay with internal reaction control enables rapid and specific detection of mollicute contaminants. The test protocol is suitable for routine quality control of cell therapeutics.
date: 2014
volume: 41
issue: 1
is part of: Transfusion Medicine and Hemotherapy
author list: authors
type: EPrint
type: ArticleEPrint
is part of: repository
has document: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (Other)
has document: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (PDF)
subject: 610 Medizin

A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (PDF)
type: Document
has file: 357096.pdf
has part: 357096.pdf

Karger
type: Organization

Transfusion Medicine and Hemotherapy
type: Collection
issn: 1660379616603818

Harald Klüter
type: Person
given name: Harald
family name: Klüter

Peter Bugert
type: Person
given name: Peter
family name: Bugert

Karen Bieback
type: Person
given name: Karen
family name: Bieback

Karin Janetzko
type: Person
given name: Karin
family name: Janetzko

Andrea Hecker
type: Person
given name: Andrea
family name: Hecker

Gabi Rink
type: Person
given name: Gabi
family name: Rink

A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (Other)
type: Document
is version of: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (PDF)
is volatile version of: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (PDF)
is index codes version of: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics (PDF)
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has part: indexcodes.txt

HTML Summary of #27237 A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics
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primary topic: A Single-Tube Real-Time PCR Assay for Mycoplasma Detection as a Routine Quality Control of Cell Therapeutics

610 Medizin
type: Concept
preferred label: 610 Medical sciences Medicine @en