First Laboratory Evaluation of FUS-3000 Plus: A New-Generation Urine Analyzer.

BACKGROUND

Urine sediment analysis is a cornerstone of diagnostic testing. This study evaluates FUS-3000 Plus, an automated urine sediment analyzer using advanced imaging and artificial intelligence, to assess its technical performance and diagnostic accuracy for routine clinical use.

METHODS

The study analyzed 98 urine samples for chemical parameters (pH, protein, blood, leukocyte esterase, and nitrite) and 76 samples for particle analysis (red blood cells [RBCs], white blood cells, epithelial cells, crystals, bacteria) by both FUS-3000 Plus and sediMAX™, the current laboratory analyzer in use. Additionally, 139 samples were tested for glucosuria and proteinuria, with results compared to the Cobas C702. Carry-over, precision, and linearity were assessed by internal quality controls in accordance with Clinical and Laboratory Standards Institute protocols. Accuracy was further evaluated using external quality controls.

RESULTS

FUS-3000 Plus demonstrated strong agreement with sediMAX for nitrites, protein, and leukocyte esterase (kappa values >0.5) and correlated well with the Cobas C702 for glucosuria and proteinuria. However, discrepancies were observed in glucosuria detection, with some samples yielding inaccurate results even during external quality control assessments. A carry-over effect for RBCs required a rinse step after highly concentrated samples.Precision was acceptable (CV: 3%-11%), and Bland-Altman plots showed strong agreement for formed elements (correlation >0.95). However, the analyzer had reduced accuracy in bacteriuria detection.

CONCLUSION

FUS-3000 Plus is a reliable tool for routine urinalysis, excelling in particle classification. However, improvements are needed in bacteriuria detection and minimizing carry-over effects. Future research should explore its ability to identify additional cellular elements and its diagnostic utility in diverse clinical populations.