Comparison of Fully Automated Urine Sediment Analyzers H800‐FUS100 and Labumat‐Urised with Manual Microscopy

Yüksel, Hatice; Kılıç, Elif; Ekinci, Aysun; Evliyaoğlu, Osman

doi:10.1002/jcla.21604

Cited by 42 publications

(57 citation statements)

References 10 publications

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“…Particle count repeatability of several urinalysis systems as the between-day and within-day precisions has been reported previously ( 15 , 16 ). The between-day and within-day precisions of Cobas 6500 were very similar to the findings of those studies.…”

Section: Discussionsupporting

confidence: 53%

“…Yuksel et al compared the fully automated urine sediment analyzers H800-FUS100 and Labumat-Urised with manual microscopy, and Akin et al reported that two automated techniques, the UriSed and IQ200, have compatible results with each other and with manual microscopy, and that the confirmation of pathological results of the automated system by manual examination may be needed ( 15 , 16 ). It has also been reported that the automated systems are not completely free of error and that one must consider the strip analysis results when interpreting automated microscopic reports, resulting in reduction of test result errors ( 27 ).…”

Section: Discussionmentioning

confidence: 99%

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Comparison of Cobas 6500 and Iris IQ200 fully-automated urine analyzers to manual urine microscopy

et al. 2016

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IntroductionUrine screening is achieved by either automated or manual microscopic analysis. The aim of the study was to compare Cobas 6500 and Iris IQ200 urine analyzers, and manual urine microscopic analysis.Materials and methodsA total of 540 urine samples sent to the laboratory for chemical and sediment analysis were analyzed on Cobas 6500 and Iris IQ200 within 1 hour from sampling. One hundred and fifty three samples were found to have pathological sediment results and were subjected to manual microscopic analysis performed by laboratory staff blinded to the study. Spearman’s and Gamma statistics were used for correlation analyses, and the McNemar test for the comparison of the two automated analyzers.ResultsThe comparison of Cobas u701 to the manual method yielded the following regression equations: y = - 0.12 (95% CI: - 1.09 to 0.67) + 0.78 (95% CI: 0.65 to 0.95) x for WBC and y = 0.06 (95% CI: - 0.09 to 0.25) + 0.66 (95% CI: 0.57 to 0.73) x for RBC. The comparison of IQ200 Elite to manual method the following equations: y = 0.03 (95% CI: - 1.00 to 1.00) + 0.88 (95% CI: 0.66 to 1.00) x for WBC and y = - 0.22 (95% CI: - 0.80 to 0.20) + 0.40 (95% CI: 0.32 to 0.50) x for RBC. IQ200 Elite compared to Cobas u701 yielded the following equations: y = - 0.95 (95% CI: - 2.13 to 0.11) + 1.25 (95% CI: 1.08 to 1.44) x for WBC and y = - 1.20 (95% CI: - 1.80 to -0.30) + 0. 80 (95% CI: 0.55 to 1.00) x for RBC.ConclusionsThe two analyzers showed similar performances and good compatibility to manual microscopy. However, they are still inadequate in the determination of WBC, RBC, and EC in highly-pathological samples. Thus, conﬁrmation by manual microscopic analysis may be useful.

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Section: Discussionsupporting

confidence: 53%

Section: Discussionmentioning

confidence: 99%

Comparison of Cobas 6500 and Iris IQ200 fully-automated urine analyzers to manual urine microscopy

et al. 2016

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“…However, precision with automated analysers was found to be superior to the precision of the manual microscopy method 7 11–13 17–19 30 34 35…”

Section: Measurement Uncertaintymentioning

confidence: 99%

“…How quickly the microscopy was performed was reported in some studies in relation to the collection time, and it varied greatly ranging between 1 hour,7 52 2 hours,8 20 32 47 59–61 64 3 hours,63 4 hours,29 46 8 hours,53 10 hours10 and 24 hours 22 25 28 48 51. In other studies, the time for completing the microscopy was given in relation to the receipt time in the laboratory, and it ranged between 1 hour,11 18 30 31 33 35 2 hours,12 13 16 19 34 3 hours58 and 4 hours after receipt 21 24 62. In some of the studies, there was only a generic statement that urines had been tested without much delay9 17 27 38 39 50 54 56 65 or no clear statements 14 15 23 26 36 37 40–45 49 55 57…”

Section: Applicability Of the Validation Datamentioning

confidence: 99%

Validation and verification of automated urine particle analysers

Bignardi

2016

J Clin Pathol

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There is often uncertainty on how validation and verification of newly introduced tests should be conducted, and there is a real risk of verification becoming a meaningless ritual, rather than a useful exercise. This article reviews the literature and makes recommendations regarding the validation and verification of automated urine particles analysers. A generic practical approach to verification is also recommended. For many analysers, the accuracy of white blood cells, epithelial cells and bacterial counts is corroborated by a number of independent evaluations; thus, any verification laboratory work could be significantly scaled down. Conversely, in the scenario that automated urine microscopy is used as a screening test to reduce the number of urines cultured, the extremely variable performance reported in the literature requires a full-scale verification to define the optimal cut-off values that give a sensitivity of >98% with the local settings and circumstances. With some analysers, the risk of carry-over also needs to be assessed, as part of the verification process, and exclusion criteria (urines requiring culture regardless of the microscopy results) need to be well defined, as there are patients or specimen types for which the performance of microscopy as a screening test may not be adequate.

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“…However, this approach can be criticized because the sediMAX in our laboratory is now fully automated on the basis of our experience, whereas for all particles except WBCs and bacteria, FUS-200 was used to recognize and count particles according to manufacturer's recommendations only. However, outcomes based on visual interpretation can be highly variable (24,25), and the agreement between analyzers is better than that between analyzers and visual interpretation of microscopic images (26). These factors suggest that to reduce variation, it may be justified to switch to automation (1).…”

Section: Comparison Of Fus-200 To Sedimaxmentioning

confidence: 99%

Assessment of FUS-200 Performance: Comparison with Quantitative Urine Culture Shows that Identifying the Right Cutoff for Optimizing Analyzer Performance Is Challenging

Gras

Henry²,

Othmane³

et al. 2017

The Journal of Applied Laboratory Medicine

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Comparison of Fully Automated Urine Sediment Analyzers H800‐FUS100 and Labumat‐Urised with Manual Microscopy

Cited by 42 publications

References 10 publications

Comparison of Cobas 6500 and Iris IQ200 fully-automated urine analyzers to manual urine microscopy

Comparison of Cobas 6500 and Iris IQ200 fully-automated urine analyzers to manual urine microscopy

Validation and verification of automated urine particle analysers

Assessment of FUS-200 Performance: Comparison with Quantitative Urine Culture Shows that Identifying the Right Cutoff for Optimizing Analyzer Performance Is Challenging

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