Vinsamlegast notið þetta auðkenni þegar þið vitnið til verksins eða tengið í það: http://hdl.handle.net/1946/34506
Over the last decade the use of LC-MS/MS has increased in clinical laboratories. Furthermore, increasing numbers of laboratories have upgraded to newer and improved instruments for better sensitivity and faster results when simultaneously analyzing GA, cortisol and cortisone. GA is known to inhibit 11 β-HSD type 2 enzyme which causes that cortisol cannot convert to cortisone and GA is also known to increase blood pressure and potassium excretion. Patients can benefit from methods which simultaneously detect all three analytes and it can lead to identifying the health problem. Validation of the analytical method is necessary before implementation of the assay in clinical laboratories.
The aim of the study was to evaluate data from validation of a quantification method and analysis of clinical samples for GA, cortisol/cortisone in human plasma and cortisol/cortisone in human urine.
Validation of the methods for quantification of GA in human plasma, cortisol and cortisone in human plasma and urine, was based on U.S. Food & Drug Administration (FDA) Guidance for Industry, Bioanalytical Method Validation and European Medicines Agency (EMA). Validation parameters that were evaluated were selectivity, LLOQ, concentration function, accuracy, precision and recovery. Subjects consumed licorice and samples were collected before and after consumption of licorice.
Quantification LC-MS/MS methods for GA, cortisol and cortisone have been validated. Validation of GA quantification method in human plasma met the acceptance criteria and was accepted, except the accuracy for LLOQ which was rejected. Validation of the quantification method for cortisol and cortisone in human plasma and urine did not meet the acceptance criteria and was rejected. After consuming licorice, the clinical sample before and after consumption of licorice for two weeks were significant different for amount of GA in human plasma. The clinical samples for cortisol and cortisone in human plasma and human urine were not significant different before and after consumption of licorice.
For all analytes it is necessary to improve the sensitivity of the quantification method and to conduct full validation of the clinical assay again. Following full validation, it is recommended that the clinical samples are re-analyzed.
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