VERIFICATION OF CYCLOSPORINE DETERMINATION IN WHOLE BLOOD USING GUIDELINE FROM CLSI

Cyloclosporine concentrations helps reduce liver and kidney toxicity and the risk of infection due to high doses of cyclosporine. Before testing on patients, it is necessary to verify the method. Objective: verify the use value of the Cyclosporine quantitative test method in whole blood on the Maglumi 800 automated immunoassay system. Subjects and methods: accuracy and precision were assessed according to CLSI EP 15-A3 guidelines. Two levels of QC material were analyzed five times per day for five days. Results: The laboratory's repeatability CV with QC level 1 and QC level 2 was 1.44% and 0.75%, which was lower than the manufacturer's published repeatability CV of 3.89% and 4.88%; the reproducibility CVs for QC level 1 and QC level 2 of the laboratory were 4.29% and 4.68%, respectively, and were lower than the reproducibility CVs of the manufacturer, which were 4.88% and 4.92%. The mean values measured for both concentration levels were not statistically different from the target concentration. Conclusion: The study showed that the method for testing cloclosporine in whole blood on the Maglumi 800 automated immunoassay system had acceptable accuracy and precision.