Abstract Objectives Proteinuria is a key biomarker for early detection, staging, and monitoring of chronic kidney disease (CKD). This study aimed to evaluate the diagnostic accuracy of the Dirui FUS-3000 Plus automated urine analyzer by comparing urine dipstick test results with the spot urine protein-to-creatinine ratio (PCR) as the reference method. Methods A retrospective cross-sectional analysis was conducted on 6,543 spot urine samples. Dipstick results were assessed in two ways by categorizing “trace” as either negative or positive. Diagnostic parameters including sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and Cohen’s kappa were calculated for two PCR cut-off values (150 mg/g and 200 mg/g). Results Diagnostic performance of the dipstick test varied according to the PCR cut-off value and the interpretation of trace results. When trace was classified as negative, sensitivity and specificity were 71.3 % and 98.3 % at a PCR cut-off of 200 mg/g, and 60.2 % and 99.1 % at a cut-off of 150 mg/g, with Cohen’s kappa values of 0.703 and 0.554, respectively (all p<0.001). When trace was classified as positive, sensitivity and specificity were 85.3 % and 88.8 % at a PCR cut-off of 200 mg/g, and 75.8 % and 92.7 % at a cut-off of 150 mg/g, with corresponding kappa values of 0.741 and 0.662 (all p<0.001). McNemar’s test was statistically significant in all analyses. Conclusions The Dirui FUS-3000 Plus provides competitive diagnostic performance in proteinuria screening. Consideration of trace results and urine concentration is crucial to minimize misclassification, especially in borderline proteinuria cases.
Muhammed Seyithanoğlu (Thu,) studied this question.