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Clinical LC-MS refers to the application of liquid chromatography–mass spectrometry as a validated analytical platform within clinical laboratories for the quantitative and qualitative measurement of small molecules, metabolites, peptides, steroids, therapeutic drugs, and toxicological compounds in human biological samples. It integrates chromatographic separation with high-specificity mass detection to achieve low-level quantitation, structural confirmation, and interference-free analysis in complex matrices such as serum, plasma, urine, and dried blood spots. Clinical LC-MS systems operate under CLIA/CAP/ISO15189 regulatory frameworks and support assay development, method validation, automated sample preparation, and LIS/EMR connectivity. Their primary purpose is to provide high accuracy and specificity for diagnostic decision-making in endocrinology, toxicology, therapeutic drug monitoring (TDM), metabolic disease screening, newborn screening, and precision medicine workflows.
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