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Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis.

ABSTRACT: BACKGROUND:This study compares the diagnostic performance (in routine urinalysis) of three URiSCAN devices and three Roche analyzers to manual microscopy and quantitative assays. METHODS:We analyzed eight dipstick tests using three URiSCAN devices. The results were compared to those of the tests performed using three Roche analyzers. The results of leukocyte and erythrocyte screens were compared to those obtained using manual microscopy. Protein, glucose, pH, and specific gravity (SG) assays performed on the URiSCAN devices were compared with the results of corresponding quantitative assays. RESULTS:The rates of agreement within one grade difference were found to be more than 94.3%. When compared with manual microscopy, the Optima provided better diagnostic performance for the detection of leukocytes compared with the Urisys 1100. Compared to the Urisys 2400, the Super plus provided better diagnostic performance with regard to both leukocytes and erythrocytes. There was good correlation between the three URiSCAN devices and each quantitative assay, except for SG detection. CONCLUSION:There were well correlated results between those of the three URiSCAN devices and those obtained using the corresponding Roche analyzers, quantitative assays, and manual microscopy. URiSCAN series devices are therefore suitable for routine urinalysis in clinical laboratories.

SUBMITTER: Ko K

PROVIDER: S-EPMC6807111 | biostudies-literature | 2016 Sep

REPOSITORIES: biostudies-literature

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Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis.

Ko Kiwoong K Kwon Min-Jung MJ Ryu Seungho S Woo Hee-Yeon HY Park Hyosoon H

Journal of clinical laboratory analysis 20150824 5

<h4>Background</h4>This study compares the diagnostic performance (in routine urinalysis) of three URiSCAN devices and three Roche analyzers to manual microscopy and quantitative assays.<h4>Methods</h4>We analyzed eight dipstick tests using three URiSCAN devices. The results were compared to those of the tests performed using three Roche analyzers. The results of leukocyte and erythrocyte screens were compared to those obtained using manual microscopy. Protein, glucose, pH, and specific gravity ...[more]

PMID: 26303237

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Project description:BackgroundDue to insufficient accuracy, urine-based assays currently have a limited role in the management of patients with bladder cancer. The identification of multiplex molecular signatures associated with disease has the potential to address this deficiency and to assist with accurate, non-invasive diagnosis and monitoring.MethodsTo evaluate the performance of Oncuria™, a multiplex immunoassay for bladder detection in voided urine samples. The test was evaluated in a multi-institutional cohort of 362 prospectively collected subjects presenting for bladder cancer evaluation. The parallel measurement of 10 biomarkers (A1AT, APOE, ANG, CA9, IL8, MMP9, MMP10, PAI1, SDC1 and VEGFA) was performed in an independent clinical laboratory. The ability of the test to identify patients harboring bladder cancer was assessed. Bladder cancer status was confirmed by cystoscopy and tissue biopsy. The association of biomarkers and demographic factors was evaluated using linear discriminant analysis (LDA) and predictive models were derived using supervised learning and cross-validation analyses. Diagnostic performance was assessed using ROC curves.ResultsThe combination of the 10 biomarkers provided an AUROC 0.93 [95% CI 0.87-0.98], outperforming any single biomarker. The addition of demographic data (age, sex, and race) into a hybrid signature improved the diagnostic performance AUROC 0.95 [95% CI 0.90-1.00]. The hybrid signature achieved an overall sensitivity of 0.93, specificity of 0.93, PPV of 0.65 and NPV of 0.99 for bladder cancer classification. Sensitivity values of the diagnostic panel for high-grade bladder cancer, low-grade bladder cancer, MIBC and NMIBC were 0.94, 0.89, 0.97 and 0.93, respectively.ConclusionsUrinary levels of a biomarker panel enabled the accurate discrimination of bladder cancer patients and controls. The multiplex Oncuria™ test can achieve the efficient and accurate detection and monitoring of bladder cancer in a non-invasive patient setting.

Project description:BackgroundSound policy, resource allocation and day-to-day management decisions in the health sector require timely information from routine health information systems (RHIS). In most low- and middle-income countries, the RHIS is viewed as being inadequate in providing quality data and continuous information that can be used to help improve health system performance. In addition, there is limited evidence on the effectiveness of RHIS strengthening interventions in improving data quality and use. The purpose of this study is to evaluate the usefulness of the newly developed Performance of Routine Information System Management (PRISM) framework, which consists of a conceptual framework and associated data collection and analysis tools to assess, design, strengthen and evaluate RHIS. The specific objectives of the study are: a) to assess the reliability and validity of the PRISM instruments and b) to assess the validity of the PRISM conceptual framework.MethodsFacility- and worker-level data were collected from 110 health care facilities in twelve districts in Uganda in 2004 and 2007 using records reviews, structured interviews and self-administered questionnaires. The analysis procedures include Cronbach's alpha to assess internal consistency of selected instruments, test-retest analysis to assess the reliability and sensitivity of the instruments, and bivariate and multivariate statistical techniques to assess validity of the PRISM instruments and conceptual framework.ResultsCronbach's alpha analysis suggests high reliability (0.7 or greater) for the indices measuring a promotion of a culture of information, RHIS tasks self-efficacy and motivation. The study results also suggest that a promotion of a culture of information influences RHIS tasks self-efficacy, RHIS tasks competence and motivation, and that self-efficacy and the presence of RHIS staff have a direct influence on the use of RHIS information, a key aspect of RHIS performance.ConclusionsThe study results provide some empirical support for the reliability and validity of the PRISM instruments and the validity of the PRISM conceptual framework, suggesting that the PRISM approach can be effectively used by RHIS policy makers and practitioners to assess the RHIS and evaluate RHIS strengthening interventions. However, additional studies with larger sample sizes are needed to further investigate the value of the PRISM instruments in exploring the linkages between RHIS data quality and use, and health systems performance.

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Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis.

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Performance Evaluation of Three URiSCAN Devices for Routine Urinalysis.

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