Comparison between Manual Methods and Automated Analyzer iQ200® Iris Diagnostics): A Study for the Optimization of Urinalysis

Henneberg, Raílson; Nascimento, Aguinaldo José do; Kussen, Gislene Maria Botão; Barreto, Fellype Carvalho; Hauser, Aline Borsato

doi:10.15344/2455-4006/2015/108

Cited by 3 publications

(2 citation statements)

References 32 publications

(34 reference statements)

Supporting

Mentioning

Contrasting

Order By: Relevance

“…However, future studies would be helpful to compare the accuracy of manual vs automated FLE interpretation as previous studies have demonstrated automated measurement of LE in urinalysis to be more accurate and consistent than manual. 39,40 Regulatory requirement of automated strip reading over the manual approach may limit the cost benefit of FLE testing.…”

Section: Discussionmentioning

confidence: 99%

Fecal Leukocyte Esterase, an Alternative Biomarker to Fecal Calprotectin in Inflammatory Bowel Disease: A Pilot Series

Trasolini

Klemm

Park

et al. 2022

Gastro Hep Advances

View full text Add to dashboard Cite

BACKGROUND AND AIMS: Fecal calprotectin (FC) is a noninvasive biomarker used in inflammatory bowel disease (IBD) management and risk stratification of nonspecific gastrointestinal symptoms. Leukocyte esterase is an inexpensive and widely available point-of-care inflammatory marker present on urinalysis test strips. We aim to assess the diagnostic accuracy of fecal leukocyte esterase (FLE) relative to FC and endoscopy and demonstrate its use as an alternative biomarker for IBD. METHODS: In this prospective cohort study, 70 patients who had FC ordered as part of standard clinical care also received FLE testing. FLE levels were compared with various FC cutoff values and endoscopy and pathology findings as the gold standard. RESULTS: As the FC cutoff increased from 50 to 500 mg/g, FLE sensitivity increased from 67% to 95% while the specificity decreased from 86% to 76%. The area under the receiver operating characteristic (AUROC) curve increased from 0.79 to 0.90. An FLE of 1þ had the best test characteristics. Among patients who underwent endoscopic evaluation, FLE demonstrated an identical sensitivity (75%) and specificity (86%) to FC in predicting endoscopic inflammation. AUROC was 0.80 for FLE and 0.85 for FC with an optimal cutoff of 2þ and 301 mg/g, respectively. When used to distinguish between patients with active IBD and no/inactive IBD, FLE had a sensitivity of 84% and specificity of 90%, comparable with the 84% and 83%, respectively, of FC. AUROC was 0.88 for FLE and 0.91 for FC with an optimal cutoff of 2þ and 145 mg/g, respectively. CONCLUSION: FLE demonstrates adequate correlation and comparable accuracy with FC in predicting endoscopic inflammation and distinguishing between patients with active vs inactive IBD.

show abstract

Section: Discussionmentioning

confidence: 99%

Fecal Leukocyte Esterase, an Alternative Biomarker to Fecal Calprotectin in Inflammatory Bowel Disease: A Pilot Series

Trasolini

Klemm

Park

et al. 2022

Gastro Hep Advances

View full text Add to dashboard Cite

show abstract

“…The ability of the cobas u 701 analyzer to screen for certain urine parameters, such as casts, crystals, and dysmorphic RBC, remains limited and further analysis by manual microscopy is required for accurate identification of clinically relevant urine particles in complex samples [37,[63], [64], [65], [66], [67], [68], [69], [70]]. Importantly, the cobas system facilitates the re-evaluation of complex samples by enabling visual review of the automated images.…”

Section: Discussionmentioning

confidence: 99%

Automated urinalysis combining physicochemical analysis, on-board centrifugation, and digital imaging in one system: A multicenter performance evaluation of the cobas 6500 urine work area

Cobbaert

Arslan

Martín³

et al. 2019

Practical Laboratory Medicine

View full text Add to dashboard Cite

BackgroundWe evaluated the analytical performance of the fully automated cobas® 6500 urine work area and its automated components—cobas u 601 and cobas u 701.Design and methodsThe study was conducted at three European centers using un-centrifuged surplus routine urine samples; all measurements were performed within 2 h of sample collection. Precision, sample carry-over, and method comparisons were evaluated per Clinical and Laboratory Standards Institute guidelines. Method comparisons: cobas u 601 versus Urisys 2400 and cobas u 411 urine test strips; and cobas u 701 versus KOVA® visual microscopy and iQ200 analyzer. Operability and functionality were assessed using questionnaires.ResultsPrecision of the entire cobas 6500 system was within predefined acceptance limits and no significant carry-over was observed. Erythrocytes, leukocytes, nitrites, and protein were in good agreement (≥93%) with cobas u 411 reflectometry. High correlation was shown between the cobas u 701 analyzer and KOVA visual microscopy for red blood cells (RBC; slope, 0.89; Pearson’s r, 0.95) and white blood cells (WBC; slope, 0.96; Pearson’s r, 0.96), demonstrating equivalence of test results. The 97.5% percentile reference values on the cobas u 701 analyzer were 5.3 cells/μL (RBC) and 6.2 cells/μL (WBC). The cobas 6500 system showed good sensitivity for small bacteria (>1 μm) and pathological casts, and the user interface, maintenance wizards, and system design were highly rated by operators.ConclusionsThe fully automated workflow, high precision, and high throughput of the cobas 6500 system have the potential to facilitate standardization of urine screening.

show abstract

Increase Trichomonas vaginalis detection based on urine routine analysis through a machine learning approach

Wang

Hung

Chen

et al. 2019

Sci Rep

View full text Add to dashboard Cite

Trichomonas vaginalis ( T . vaginalis ) detection remains an unsolved problem in using of automated instruments for urinalysis. The study proposes a machine learning (ML)-based strategy to increase the detection rate of T . vaginalis in urine. On the basis of urinalysis data from a teaching hospital during 2009–2013, individuals underwent at least one urinalysis test were included. Logistic regression, support vector machine, and random forest, were used to select specimens with a high risk of T . vaginalis infection for confirmation through microscopic examinations. A total of 410,952 and 428,203 specimens from men and women were tested, of which 91 (0.02%) and 517 (0.12%) T . vaginalis -positive specimens were reported, respectively. The prediction models of T . vaginalis infection attained an area under the receiver operating characteristic curve of more than 0.87 for women and 0.83 for men. The Lift values of the top 5% risky specimens were above eight. While the most risky vigintile was picked out by the models and confirmed by microscopic examination, the incremental cost-effectiveness ratios for T . vaginalis detection in men and women were USD$170.1 and USD$29.7, respectively. On the basis of urinalysis, the proposed strategy can significantly increase the detection rate of T . vaginalis in a cost-effective manner.

show abstract

Comparison between Manual Methods and Automated Analyzer iQ200® Iris Diagnostics): A Study for the Optimization of Urinalysis

Cited by 3 publications

References 32 publications

Fecal Leukocyte Esterase, an Alternative Biomarker to Fecal Calprotectin in Inflammatory Bowel Disease: A Pilot Series

Fecal Leukocyte Esterase, an Alternative Biomarker to Fecal Calprotectin in Inflammatory Bowel Disease: A Pilot Series

Automated urinalysis combining physicochemical analysis, on-board centrifugation, and digital imaging in one system: A multicenter performance evaluation of the cobas 6500 urine work area

Increase Trichomonas vaginalis detection based on urine routine analysis through a machine learning approach

Contact Info

Product

Resources

About