Abstract
Molecular diagnostics differs from routine laboratory testing in several crucial features. Software packages and systems designed for quality assurance (QA) and quality control (QC) for assays performed on automated analysers cannot be used for molecular diagnostics. Since molecular assays are usually qualitative or semi-quantitative, it is impossible to directly translate concepts from standard testing into the molecular arena. We developed a software package that allows the monthly monitoring of genotyping results for our high volume assays. The variance of these monthly results is small and allowed us to establish a warning threshold that would alert us to any potential troubles in an assay prior to the controls failing. We have also developed some manual QA procedures for Sanger Sequencing based assays that will be shared with the audience. The challenges of QA for advanced sequencing with some suggested potential solutions will also be discussed.
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