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SEDL / STP / STP1452-EB / STP11630S
Development and Validation of a Detection Method for a Broad Range of Human Papillomavirus Types
Galbraith, DN Director of Technical Services and Regulatory Affairs, Project Manager, Laboratory Manager, Study Director, Study Director and Director of Development, Q-One Biotech Ltd., West of Scotland Science Park, Glasgow
Collins, T Director of Technical Services and Regulatory Affairs, Project Manager, Laboratory Manager, Study Director, Study Director and Director of Development, Q-One Biotech Ltd., West of Scotland Science Park, Glasgow
Black, J Director of Technical Services and Regulatory Affairs, Project Manager, Laboratory Manager, Study Director, Study Director and Director of Development, Q-One Biotech Ltd., West of Scotland Science Park, Glasgow
McManus, B Director of Technical Services and Regulatory Affairs, Project Manager, Laboratory Manager, Study Director, Study Director and Director of Development, Q-One Biotech Ltd., West of Scotland Science Park, Glasgow
McMutrie, D Director of Technical Services and Regulatory Affairs, Project Manager, Laboratory Manager, Study Director, Study Director and Director of Development, Q-One Biotech Ltd., West of Scotland Science Park, Glasgow
Lovatt, A Director of Technical Services and Regulatory Affairs, Project Manager, Laboratory Manager, Study Director, Study Director and Director of Development, Q-One Biotech Ltd., West of Scotland Science Park, Glasgow
Pages: 8 Published: Jan 2004
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Abstract
Human papillomaviruses (HPVs) are viruses that are almost unique in their tropism for human skin cells; they also have the potential to cause severe pathology. These viruses present a significant risk to contaminate tissue engineered skin replacement products that use human-derived skin cells as part of their manufacture. Eight pairs of primers and appropriate DNA oligonucleotide probes were designed from a relatively conserved region of the LI open reading frame of HPV. TaqMan® PCR using these primer/probe sets was found to be capable of detecting HPV-DNA in a background of cellular material likely to be present in skin replacement products. The assay is more sensitive than any currently described in the scientific literature and can be completed in a single working day making it suitable for testing the short shelf life that many of these products have.
Keywords:
Safety, Artificial skin, Human papillomavirus, PCR
Paper ID: STP11630S
Committee/Subcommittee: F04.04
DOI: 10.1520/STP11630S
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