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Guidance for Approving Clinical Molecular Pathology Tests

Qibin Qi

Identity testing, cancer screening, human leukocyte antigen typing, pharmacogenetics, and other fields continue to see an increase in the usage of DNA- and RNA-based diagnostics. The enormous increase in information about the molecular causes of disease and the development of technological capabilities are two factors that contribute to progress. Every molecular test may have limits that need to be carefully evaluated before being used in clinical settings in addition to the requirements for clinical utility. Through the process of test validation, analytic and clinical performance features, as well as test limitations, are identified and recorded. To give a reasoned method for integrating molecular testing into the clinical laboratory, it is necessary to outline the accepted principles of test validation and pertinent laws in the United States.