Abstract

LINA TRIGO, Orsini Myriam  and  PARRA POMA, Cinthia Maribel. Determination of clinical decision limits of blood cyclosporine in patients with renal transplantation. Rev.Cs.Farm. y Bioq [online]. 2020, vol.8, n.1, pp.53-66. ISSN 2310-0265.

Abstract Introduction: Decision limits or cut-off values are "red flags" for medical diagnosis. They are obtained by carefully designed studies to be able to establish a value that allows a medical decision to follow a treatment. Objective: To determine the clinical decision limits of Cyclosporin A in whole blood of kidney transplant patients. Methods: For data treatment and calculation of decision limits, a computer and biostatistical methodology was used with IBM SPSS software, performing Normality Tests, graphic tests such as QQ plots, Kolmogorov-SmirnovTest, Lillefors Test and Shapiro Test -Wilks. Results: The study group made up of kidney transplant patients treated during 2016 to 2019, classified by transplant time. The acceptance criteria were: Use of internal quality control, with satisfactory results using control charts and the detection of outliers using the Grubbs test. Ob-taining basal levels of 0-3 months 181-241 ng / ml; 3-12 months 120-147 ng / ml and over 12 months of 81-119 ng / ml, and for a maximum concentration of 1 month 1193-2025 ng / ml; 2 months 1379-1765 ng / ml; 3 months 1060-1556 ng / ml; 4-6 months 880-1293 ng / ml; 7-12 months 735-1039 ng / ml and more than 12 months 643-960 ng / ml. Conclusion: The clinical decision limits ob-tained are perfectly in line with those of the bibliography with the advantage that now there are defined limits for our population, becoming "alerts" for medical diagnosis.

Keywords : Clinical decision limits; Cyclosporin A; Bioavailability; Renal Transplantation.

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