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Licensed Unlicensed Requires Authentication Published by De Gruyter October 12, 2019

Comparison of the diagnostic performance of two automated urine sediment analyzers with manual phase-contrast microscopy

  • Dietmar Enko EMAIL logo , Ingeborg Stelzer , Michael Böckl , Brigitta Derler , Wolfgang J. Schnedl , Petra Anderssohn , Andreas Meinitzer and Markus Herrmann

Abstract

Background

Recently, several manufacturers have launched automated urinalysis platforms. This study aimed to compare the diagnostic performance of the UF-5000 (Sysmex Corporation, Kobe, Japan) and the cobas® u 701 (Roche Diagnostics, Rotkreuz, Switzerland) urine sediment analyzers with manual phase-contrast microscopy as the reference method.

Methods

A total of 195 urine samples were analyzed on both automated platforms and subjected to manual microscopic examination. Agreement was assessed by Cohen’s kappa (κ) analysis. Sensitivities and specificities were calculated.

Results

The agreement of the UF-5000 with manual microscopy was almost perfect (κ > 0.8) for red (RBC) and white blood cells (WBC), renal tubular epithel cells, hyaline casts, bacteria (BACT) and yeast (YLC), substantial (κ = 0.61–0.80) for squamous epithel cells (SEC) and pathologic casts, and moderate (κ = 0.41–0.60) for transitional epithel cells. The cobas® u 701 showed substantial agreement (κ = 0.61–0.80) for WBC, moderate agreement (κ = 0.41–0.60) for hyaline casts, and fair agreement (κ = 0.21–0.40) for RBC, SEC, non-squamous epithel (NEC), pathologic casts, BACT and YLC. The UF-5000 sensitivities ranged between 98.5% for RBC and 83.3% for pathological casts. The cobas® u 701 showed sensitivities between 83.0% for WBC and 31.6% for YLC.

Conclusions

The UF-5000 (Sysmex) analyzer showed a better diagnostic agreement with manual phase-contrast microscopy compared to the cobas® u 701 (Roche) module. The Sysmex platform showed reliable results for urine sediment analysis. However, pathological samples should be verified with manual microscopy.


Corresponding author: Dietmar Enko, MD, Clinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Auenbruggerplatz 15, 8036 Graz, Austria; and Institute of Clinical Chemistry and Laboratory Medicine, General Hospital Hochsteiermark, Leoben, Austria, Phone: +43 316 385-13145, Fax: +43 316 385-13430

  1. Author contributions: DE wrote the manuscript and supervised this study project. All the authors have accepted responsibility for the entire content of this submitted manuscript and approved submission.

  2. Research funding: None declared.

  3. Employment or leadership: None declared.

  4. Honorarium: None declared.

  5. Competing interests: The funding organization(s) played no role in the study design; in the collection, analysis, and interpretation of data; in the writing of the report; or in the decision to submit the report for publication.

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Received: 2019-08-30
Accepted: 2019-09-22
Published Online: 2019-10-12
Published in Print: 2020-01-28

©2019 Walter de Gruyter GmbH, Berlin/Boston

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