Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

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Abstract

Objective

Various point-of-care testing (POCT) urine analysers are commercially available for routine urine analysis in general practice. The present study compares analytical performance, agreement and user-friendliness of six different POCT urine analysers for diagnosing urinary tract infection in general practice.

Setting

All testing procedures were performed at a diagnostic centre for primary care in the Netherlands. Urine samples were collected at four general practices.

Primary and secondary outcome measures

Analytical performance and agreement of the POCT analysers regarding nitrite, leucocytes and erythrocytes, with the laboratory reference standard, was the primary outcome measure, and analysed by calculating sensitivity, specificity, positive and negative predictive value, and Cohen's κ coefficient for agreement. Secondary outcome measures were the user-friendliness of the POCT analysers, in addition to other characteristics of the analysers.

Results

The following six POCT analysers were evaluated: Uryxxon Relax (Macherey Nagel), Urisys 1100 (Roche), Clinitek Status (Siemens), Aution 11 (Menarini), Aution Micro (Menarini) and Urilyzer (Analyticon). Analytical performance was good for all analysers. Compared with laboratory reference standards, overall agreement was good, but differed per parameter and per analyser. Concerning the nitrite test, the most important test for clinical practice, all but one showed perfect agreement with the laboratory standard. For leucocytes and erythrocytes specificity was high, but sensitivity was considerably lower. Agreement for leucocytes varied between good to very good, and for the erythrocyte test between fair and good. First-time users indicated that the analysers were easy to use. They expected higher productivity and accuracy when using these analysers in daily practice.

Conclusions

The overall performance and user-friendliness of all six commercially available POCT urine analysers was sufficient to justify routine use in suspected urinary tract infections in general practice.

Related collections

Most cited references 12

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The urine dipstick test useful to rule out infections. A meta-analysis of the accuracy

Walter LJM Devillé, Joris Yzermans, Nico van Duijn … (2004)

Background Many studies have evaluated the accuracy of dipstick tests as rapid detectors of bacteriuria and urinary tract infections (UTI). The lack of an adequate explanation for the heterogeneity of the dipstick accuracy stimulates an ongoing debate. The objective of the present meta-analysis was to summarise the available evidence on the diagnostic accuracy of the urine dipstick test, taking into account various pre-defined potential sources of heterogeneity. Methods Literature from 1990 through 1999 was searched in Medline and Embase, and by reference tracking. Selected publications should be concerned with the diagnosis of bacteriuria or urinary tract infections, investigate the use of dipstick tests for nitrites and/or leukocyte esterase, and present empirical data. A checklist was used to assess methodological quality. Results 70 publications were included. Accuracy of nitrites was high in pregnant women (Diagnostic Odds Ratio = 165) and elderly people (DOR = 108). Positive predictive values were ≥80% in elderly and in family medicine. Accuracy of leukocyte-esterase was high in studies in urology patients (DOR = 276). Sensitivities were highest in family medicine (86%). Negative predictive values were high in both tests in all patient groups and settings, except for in family medicine. The combination of both test results showed an important increase in sensitivity. Accuracy was high in studies in urology patients (DOR = 52), in children (DOR = 46), and if clinical information was present (DOR = 28). Sensitivity was highest in studies carried out in family medicine (90%). Predictive values of combinations of positive test results were low in all other situations. Conclusions Overall, this review demonstrates that the urine dipstick test alone seems to be useful in all populations to exclude the presence of infection if the results of both nitrites and leukocyte-esterase are negative. Sensitivities of the combination of both tests vary between 68 and 88% in different patient groups, but positive test results have to be confirmed. Although the combination of positive test results is very sensitive in family practice, the usefulness of the dipstick test alone to rule in infection remains doubtful, even with high pre-test probabilities.

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Urine sediment analysis: Analytical and diagnostic performance of sediMAX - a new automated microscopy image-based urine sediment analyser.

Zahur Zaman, Giovanni Battista Fogazzi, Giuseppe Garigali … (2010)

We evaluated the analytical and diagnostic performance of sediMAX (77 Elektronika, Budapest, Hungary), a new automated microscopy image-based urine sediment analyser (which in some countries is also called Urised) in comparison with visual phase-contrast microscopy.

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Quantitative evaluation of urinalysis test strips.

Joris Penders, T Fiers, Joris R. Delanghe (2002)

Urine test strip results are generally reported in categories (i.e., ordinal scaled), but automated strip readers are now available that can report quantitative data. We investigated the possible use of these meters to complement flow cytometry of urine and compared reflectance readings with quantitative determinations of urinary glucose and microalbumin. We compared URISYS 2400 (Roche) quantitative reflectance data with data from the UF-100 (Sysmex) and biochemical data for 436 nonpathologic and pathologic urine samples. Reproducibility of the reflectance signal was good for high- and low-concentration urine pools for protein (0.8% and 0.9% and 1.5% and 2.2% within and between runs, respectively), leukocyte esterase (1.1% and 1.0%; 5.1% and 1.2%), hemoglobin (1.7% and 1.1%; 8.9% and 1.1%) and glucose (2.1% and 0.5%; 6.5% and 2.3%). Fair agreement was obtained between UF-100 and test strip reflectance data for erythrocytes and hemoglobin (r = -0.680) and leukocytes and leukocyte esterase (r = -0.688). Higher correlations were observed for biochemical and test strip data comparing protein and albumin (r = -0.825) and glucose data (r = -0.851). The lower limits of detection for erythrocytes and leukocytes were 8 x 10(6)/L and 19 x 10(6)/L, respectively. The protein test (n = 220) detected 86% (95% confidence interval, 78-92%) of samples with <30 mg/L albumin with a specificity of 84% (95% confidence interval, 76-91%). In urine test strip analysis, quantitative hemoglobin and leukocyte esterase reflectance data are complementary with flow cytometric results and glucose and albumin results.

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Author and article information

Journal

Journal ID (nlm-ta): BMJ Open

Journal ID (iso-abbrev): BMJ Open

Journal ID (hwp): bmjopen

Journal ID (publisher-id): bmjopen

Title: BMJ Open

Publisher: BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )

ISSN (Electronic): 2044-6055

Publication date Collection: 2015

Publication date (Electronic): 16 May 2015

Volume: 5

Issue: 5

Electronic Location Identifier: e006857

Affiliations

[1 ]University Medical Center Utrecht, Julius Center for Health Sciences and Primary Care , Utrecht, The Netherlands

[2 ]Saltro, Diagnostic Center for Primary Care , Utrecht, The Netherlands

Author notes

[Correspondence to ] Dr Rogier M Hopstaken; r.hopstaken@ 123456saltro.nl

Article

Publisher ID: bmjopen-2014-006857

DOI: 10.1136/bmjopen-2014-006857

PMC ID: 4442241

PubMed ID: 25986635

SO-VID: 65f94c6e-f66d-42dd-86bc-87bf8a0dfcdd

License:

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

History

Date received : 8 October 2014

Date revision received : 4 February 2015

Date accepted : 17 March 2015

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Analytical performance, agreement and user-friendliness of six point-of-care testing urine analysers for urinary tract infection in general practice

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Abstract

Objective

Setting

Primary and secondary outcome measures

Results

Conclusions

Related collections

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Most cited references 12

The urine dipstick test useful to rule out infections. A meta-analysis of the accuracy

Urine sediment analysis: Analytical and diagnostic performance of sediMAX - a new automated microscopy image-based urine sediment analyser.

Quantitative evaluation of urinalysis test strips.

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Cited by 7

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