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

Area of Science:

• Clinical Chemistry
• Medical Diagnostics
• Laboratory Automation

Background:

• Urine sediment analysis is crucial for diagnosing various medical conditions.
• Automated analyzers offer potential for improved efficiency and accuracy in urinalysis.

Purpose of the Study:

• To evaluate the technical performance and diagnostic accuracy of the FUS-3000 Plus automated urine sediment analyzer.
• To compare its performance against existing laboratory methods for routine clinical use.

Main Methods:

• Analyzed urine samples for chemical and particle parameters using FUS-3000 Plus and sediMAX™.
• Compared glucosuria and proteinuria results with Cobas C702.
• Assessed carry-over, precision, and linearity using internal and external quality controls.

Main Results:

• FUS-3000 Plus showed strong agreement for nitrites, protein, and leukocyte esterase.
• Good correlation was observed for glucosuria and proteinuria with Cobas C702, but with some discrepancies.
• Acceptable precision was noted, but reduced accuracy in bacteriuria detection and a carry-over effect for red blood cells were identified.

Conclusions:

• The FUS-3000 Plus is a reliable tool for routine urinalysis, especially for particle classification.
• Further optimization is needed for bacteriuria detection and to mitigate carry-over effects.
• Future studies should investigate its utility in diverse populations and for identifying additional cellular elements.