{"title":"First Laboratory Evaluation of FUS-3000 Plus: A New-Generation Urine Analyzer.","authors":"Yasmine Nezzar, Elena Lazarova, Monia Chemais","doi":"10.1093/jalm/jfaf111","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>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.</p>","PeriodicalId":46361,"journal":{"name":"Journal of Applied Laboratory Medicine","volume":" ","pages":""},"PeriodicalIF":1.9000,"publicationDate":"2025-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Applied Laboratory Medicine","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1093/jalm/jfaf111","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
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Abstract
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.
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