SO SÁNH ĐỘ TƯƠNG ĐỒNG GIỮA HAI HỆ THỐNG MÁY ARCHITECT VÀ MAGLUMI-X3 TRONG ĐỊNH LƯỢNG TACROLIMUS MÁU TOÀN PHẦN

Abstract

Objectives: To compare the similarity and clinical interchangeability between the ARCHITECT and MAGLUMI-X3 immune systems in the quantification of whole blood Tacrolimus. Methods: A descriptive, comparative study was conducted on 106 EDTA-anticoagulated whole blood samples from patients undergoing Tacrolimus treatment. Samples were analyzed using the ARCHITECT and MAGLUMI-X3 systems according to the manufacturer's protocol. The comparative analysis between the two methods was assessed using Bland-Altman analysis, Passing-Bablok regression, and estimation of bias at clinical decision points (5 and 12 ng/mL) according to CLSI EP09 guidelines. Results: The results of Tacrolimus quantification on the two systems showed a strong linear correlation (Spearman correlation coefficient r = 0.971; p < 0.0001). Analysis showed a mean bias of -0.8 ng/mL ± 0.7 (-12.0 ± 7.65%). Passing-Bablok regression analysis showed no fixed bias. However, a proportional bias with a slope coefficient b = 0.86 (95%CI: 0.78 - 0.95) was observed. At the clinical decision point of 5 ng/mL, the bias exceeded the acceptable limit according to CLSI EP09 (case E); at 12 ng/mL, the bias was in case D. Conclusion: ARCHITECT and MAGLUMI-X3 correlate well in the quantification of whole blood Tacrolimus. However, the results between the two systems cannot be used interchangeably.