Quality Control and Laboratory Issues

The best method for testing for TP53 mutation status in clinical samples is controversial. While some groups believe that IHC testing, with its accuracy ranging from 80% to 90% for the prediction of TP53 mutation is sufficient, others recommend that either SSCP or complete gene sequencing be performed to confirm TP53 mutation status. In addition, since TP53 expression can be silenced by epigenetic events, such as methylation of the promoter region of the gene, the relative impact of mutation detection versus expression silencing has only recently been considered. TP53 testing is generally performed for research purposes, and no clinical quality-assurance programs for laboratory accuracy are currently available.


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