Accuracy and clinical application of a REF-XT01 uric acid meter / 中华内分泌代谢杂志

ABSTRACT

Objective:This study aimed to evaluate the accuracy of a portable REF-XT01 uric acid meter in measuring blood uric acid concentration, and to determine whether the results of the uric acid meter could be used to guide the adjustment of uric acid-lowering drugs.Methods:1 551 subjects were enrolled from the Gout Clinical Medical Center of the Affiliated Hospital of Qingdao University. The fasting venous blood was collected and the serum uric acid was measured by an automatic biochemical analyzer. Meanwhile, the capillary blood uric acid was measured by fingertip puncture using the REF-XT01 uric acid meter. Linear regression, intra-group correlation coefficient(ICC), and Bland-Altman plots were used to analyze the uric acid concentration correlation between the biochemical analyzer(sUA BA)and the uric acid meter(sUA UM). The receiver operating characteristic curve(ROC curve)was conducted to evaluate whether sUA UM can be used as a reference for the gout patients to take uric acid-lowering drugs. Results:The regression analysis showed correlation between sUA BA and sUA UM, with the regression formula Y=0.875X+ 39.525( r=0.84, P<0.01)and the ICC was 0.829(95% CI 0.814-0.844, P<0.01). The Bland-Altman diagram showed a good consistence(the absolute deviation was-143.4-114.5 μmol/L, mean deviation was -14.4 μmol/L)between sUA BA and sUA UM. The sensitivity was 96.61%, specificity was 48.81%, and the area under the ROC curve(AUC)was 0.926( P<0.01)when 300 μmol/L was defined as the detection threshold of the uric acid meter, the sensitivity was 90.98%, specificity was 66.78%, and the area under the ROC curve(AUC)was 0.914( P<0.01)when 360 μmol/L was defined as the detection threshold of the uric acid meter. Conclusion:REF-XT01 uric acid meter is applicable for the adjustment of uric acid-lowering drugs for the gout patients, because of its high accuracy for the detection of uric acid.