A sensitive quantitative test strip based point-of-care albuminuria screening assay

Decavele, An-Sofie; Fiers, Tom; Penders, Joris; Delanghe, Joris

doi:10.1515/cclm.2012.0849

Cited by 12 publications

(12 citation statements)

References 17 publications

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“…The Behring Nephelometer II analyzer (Siemens, Marburg, Germany) was used for assessment of urinary albumin concentration (cutoff 20 mg/L). The immunonephelometric assay was carried out using commercially available Siemens antibodies and the WHO/College of American Pathologists certified reference material 470 …”

Section: Methodsmentioning

confidence: 99%

Semiquantitative, fully automated urine test strip analysis

Oyaert

Delanghe

2019

Clinical Laboratory Analysis

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ObjectivesUrinalysis is one of the most frequently ordered diagnostic laboratory tests. In order to reduce workload and costs, rapid screening tests such as urine test strip analyses are applied. The aim of this study was to evaluate the analytical performance of the UC‐3500 as well as the diagnostic performance in comparison with reference methods.Design and methodsWe measured within‐run and between‐run imprecision based on quantitative reflectance values. 347 prospectively included urine specimens were investigated for the presence of glucose, protein, albumin, leukocyte esterase, and hemoglobin peroxidase activity, and ordinal scale results were compared to an automated urine particle analyzer (UF‐5000, Sysmex, Kobe, Japan) and wet chemistry (Roche Cobas 8000, Mannheim, Germany).ResultsWithin‐run and between‐run imprecision results based on reflectance data for both the 9 and 11 parameter test strips ranged from 0.07% to 1.36% for the low‐level control and from 0.37% to 6.13% for the high‐level control, depending on the parameter. Regarding diagnostic performance, the sensitivity/specificity for glucose, protein, albumin, leukocyte esterase, and hemoglobin peroxidase was 100/60%, 94.2/88.2%, 81.8/89.2%, 81.7/92.8%, and 85.1/88.6%, respectively; the negative predictive value was 100%, 83.3%, 89.1%, 94.6%, and 96.1%. The Spearman correlation coefficients of the UC‐3500 vs reference methods ranged from 0.915 to 0.967, depending on the parameter.ConclusionThis fully automated urine test strip analyzer overall shows a satisfying performance and can reliably screen out negative urine samples in order to focus on further characterization of positive samples in the following steps of the workflow.

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Section: Methodsmentioning

confidence: 99%

Semiquantitative, fully automated urine test strip analysis

Oyaert

Delanghe

2019

Clinical Laboratory Analysis

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“…According to the reflectance theory formulated by Kubelka and Munk [5], the reciprocal value of reflectance readings is proportional to the concentration of the measured analyte. Applications of these quantitative test strip readings have been described for ketones [6] and albumin [7].…”

Section: Test Strip Technologymentioning

confidence: 99%

Progress in Automated Urinalysis

2019

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New technological advances have paved the way for significant progress in automated urinalysis. Quantitative reading of urinary test strips using reflectometry has become possible, while complementary metal oxide semiconductor (CMOS) technology has enhanced analytical sensitivity and shown promise in microalbuminuria testing. Microscopy-based urine particle analysis has greatly progressed over the past decades, enabling high throughput in clinical laboratories. Urinary flow cytometry is an alternative for automated microscopy, and more thorough analysis of flow cytometric data has enabled rapid differentiation of urinary microorganisms. Integration of dilution parameters (e.g., creatinine, specific gravity, and conductivity) in urine test strip readers and urine particle flow cytometers enables correction for urinary dilution, which improves result interpretation. Automated urinalysis can be used for urinary tract screening and for diagnosing and monitoring a broad variety of nephrological and urological conditions; newer applications show promising results for early detection of urothelial cancer. Concomitantly, the introduction of matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOF MS) has enabled fast identification of urinary pathogens. Automation and workflow simplification have led to mechanical integration of test strip readers and particle analysis in urinalysis. As the information obtained by urinalysis is complex, the introduction of expert systems may further reduce analytical errors and improve the quality of sediment and test strip analysis. With the introduction of laboratory-on-a-chip approaches and the use of microfluidics, new affordable applications for quantitative urinalysis and readout on cell phones may become available. In this review, we present the main recent developments in automated urinalysis and future perspectives.

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“…The landscape of urinalysis has markedly progressed during the last decades. Automatic reading of urine test strips has paved the way for a more quantitative analysis of test strip results [2,3]. In the same way, the evolution Brought to you by | Ghent University Library Authenticated Download Date | 7/20/18 10:36 AM from microscopy to automated flow cytometry for urine sediment analysis has proven the excellent analytical performance of these analyses [9].…”

Section: Discussionmentioning

confidence: 99%

“…However, many clinical laboratories still adhere to expressing urinary test strip results in an ordinal scale and apparently are not fully aware of the possibilities offered by modern technology. Introduction of modern complementary metal oxide semiconductor (CMOS) technology in strip analysis has allowed very sensitive quantification of test pad colors, as demonstrated for urinary albumin, where quantitative analysis in the micro-albumin range has been reported [3,4]. Concomitantly, urinary flow cytometry has been introduced in urinalysis, where complex automated analysis of the individual urinary particles has led to major analytical and diagnostic improvements [5][6][7][8].…”

Section: Introductionmentioning

confidence: 99%