Abstract
Mass spectrometric assays for clinical diagnostic applications require substantial laboratory resources to provide appropriate results over the lifetime of the test. This chapter will address the means in which long-term success of mass spectrometry testing can be implemented. Best practice recommendations for the transition from validation to launch of the newly developed assay will be discussed. Experiments designed to ensure the longitudinal performance expectations of the assay, as well as quality assurance aspects of data review and instrument maintenance will be introduced to assist readers in providing quality results from mass spectrometric platforms.
Published Version
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