Automated Urine Analyzer Research Articles

B-006 Use of Sysmex UN-3000 Research Parameters for Semiquantitative Analysis of Urine Microscopic Elements

Abstract Background Microscopic examination of urine is an important component of urine analysis. However, it is labor-intensive and requires a skilled microscopist. The Sysmex UN-3000 (Kobe, JP) combines a Siemens CLINITEK Novus (Munich, GER) with a Sysmex UF-5000 flow cytometer and Sysmex UD-10 digital imaging device for fully automated urine analysis. It is FDA-approved for quantitation of red and white blood cells, epithelial cells, casts, and bacteria. It also flags for other particles such as sperm, yeast, pathologic casts, and crystals, which can then be confirmed on the UD-10. We sought to determine if and how the UF-5000 research parameter results could be used for semi-quantitative grading of pathologic casts, squamous epithelial cells, non-squamous epithelial cells, and crystals to match our reporting system. Methods Urine samples were analyzed by the UN-3000 and by manual review of urine sediment per laboratory protocols. Epithelial cells and crystals grades were none seen, few, moderate, many. Cast grades were 0, 1-3, 4-10, and >10. Results of manual microscopy were used to determine numerical cutoffs for the UF-5000 results which would agree within one grade in ≥90% of samples. Sperm and yeast are reported as either present or absent. For these particles, manual microscopy was compared to the results of the UF-5000 flagging and subsequent review of the UD-10 images. Results Rate of agreement between the methods is shown in the table. For sperm the UN-3000 showed 91.7% sensitivity and 100% specificity; for yeast, 93.8% sensitivity and 97.7% specificity. Conclusions We were able to use the research parameters from the UF-5000, in conjunction with the UD-10, to perform semi-quantitative grading. Adoption of this analyzer increases automation, with 70% of samples auto-validating per our protocols, while still conforming to our previous reporting system.

Comparison of Two Automated Urine Analyzers (URiSCAN Super + YD Diagnostics and Sysmex UC-3500–UF-5000 Urine Chemistry Analyzer) with Routine Microscopy

Background and Aim: Urinalysis is one of the most commonly performed screening tests in the clinical laboratory to diagnose and monitor various urological as well as systemic conditions. Newly developed automated urine analyzers are expected to routinely screen urine in less time compared to conventional routine microscopy and provide clinicians with prompt clinical information with a lower false-negative rate. The study aimed to evaluate the diagnostic performance of the two automated urine analyzers, URiSCAN Super + YD Diagnostics and Sysmex UC-3500–UF-5000 urine analyzer and compare them with microscopy. Materials and Methods: This was a prospective study performed on 124 randomly selected samples of patients coming to the clinical pathology laboratory at a tertiary care hospital for 3 months between March 1, 2022 and May 30, 2022. Each sample was taken for both automated analyzer testing and microscopic evaluation. The results of urine examination consisting of cells, formed elements, and microorganisms were compared between both the automated urine analyzers and microscopy, and the degree of concordance was calculated utilizing Cohen’s kappa (κ) analysis to see the concordance between all three values. The statistical analyses were performed using SPSS version 25, developed by IBM Co, and P < 0.05 was considered statistically significant. Results: The degree of concordance of red blood cell (RBC), white blood cell (WBC), and epithelial cells (ECs) was good between the two automated analyzers, URiSCAN Super + YD Diagnostics and Sysmex UC-3500–UF-5000 urine analyzer and microscopy with P < 0.05. The concordance between the Sysmex UC-3500–UF-5000 urine analyzer and manual microscopy was better than between manual microscopy and URiSCAN Super + YD Diagnostics. There was no concordance between any of these methods for either crystals, cast, bacteria, and fungi with P > 0.05. Conclusion: The results from the automated analyzers for RBCs, WBCs, and ECs were similar to the result of manual microscopy, and the analyzers can be relied on for testing and can help in reducing turnaround time of routine urine examination. However, bacteria, fungi, dysmorphic red cells, casts, and crystals need to be analyzed by microscopic examination before giving a final diagnosis.

Evaluation of labsan tricell-1000 automated urine analyzer for the erythrocyte and leukocyte count performances

Evaluation of labsan tricell-1000 automated urine analyzer for the erythrocyte and leukocyte count performances

Simultaneous Detection of Citric Acid and Oxalic Acid Based on Dual Spectrum and Biomimetic Peroxidase for Urolithiasis Screening with a Fully Automatic Urine Analyzer.

Urolithiasis stands as a prevalent ailment within the urinary system, with hyperoxaluria and hypocitraturia being the most frequent manifestations characterized by excessive oxalic acid (OA) and deficient citric acid (CA) levels in urine. Detecting these compounds in urine quantitatively holds paramount importance for early urolithiasis screening. Existing methodologies fall short in achieving simultaneous and on-site identification of OA and CA, posing challenges for accurate urolithiasis screening. Addressing this concern, the study successfully accomplishes the concurrent identification of OA and CA in urine through a combination of dual-spectral analysis and biomimetic peroxidase utilization. Bovine serum albumin and dithiothreitol-modified copper nanoclusters (BSA-DTT-CuNCs) are employed as biomimetic peroxidases, effectively mitigating interference and enabling the simultaneous determination of OA and CA. The quantification range spans from 0 to 12mm for OA and 0.5 to 2.5mm for CA, with detection limits of 0.18 and 0.11mm, respectively. To facilitate swift and on-location urine analysis, a fully automated urine analyzer (FAUA) is introduced that streamlines the process of biomarker pretreatment and identification within urine samples. Validation with real urine samples from urolithiasis patients demonstrates the method's diagnostic precision, highlighting the dual-spectral technique and analyzer's promising role in urolithiasis screening.

B-010 Comparison of Manual Urine Dipstick and Microscopy With Automated UC-3500 and UF-4000 Sysmex UN Series Urinalysis; A Comparative Experimental Research Approach at an Urban Referral Hospital in Ghana

Abstract Background Urine analysis is one of the most common tests for assessing urinary-tract and kidney diseases. In recent years several automated instruments examining urine have been introduced. Though the introduction of automated urine analyzers is expected to reduce the labour involved, turnaround time and potential assay variations, manual urine analysis remains the gold standard or reference method for the analysis of urine. The new Sysmex UN-Series is believed to offer superior performance than other automated systems and manual methods. Methodology A total of 67 routine freshly voided midstream urine samples were analyzed within 1 hour in our study. The results of the automated system were compared with the results of the manual processing which consisted of physical, dipstick chemistry and sediment analysis. Correlation and concordance/agreement between the automated and the manual system were assessed by Bland-Altman plot and Cohen’s Kappa analysis respectively. Results There was a significant fair agreement between the manual analysis and Sysmex UF-3500, in the determination of urine physicochemical parameters (k = 0.193, P = 0.004). Both showed a significant moderate correlation (r = 0.593, P < 0.001) and a significant fair agreement (κ = 0.109, P < 0.001) for specific gravity and pH determination respectively. The best concordance between the two methods was in the nitrates (κ = 1.000, P < 0.001). Both systems recorded strong positive correlation for RBC (r = 0.951 and R2 = 0.904) and WBC (r = 0.91 and R2 = 0.822, P < 0.001) counts. Together, they had a significant good agreement [(65/67(97.0%), κ = 0.734, P < 0.001)] and a significant fair agreement [(48/67 (71.6%) κ = 0.065, P = 0.491)] for cast and bacteria counts correspondingly. Conclusion We conclude that the new automated Sysmex-UN series urine analyzer can be safely used in our laboratory since it demonstrated good performance and compatibility with the manual method. We recommend that microscopy results of the automated platform should be confirmed by manual microscopy, particularly in pathological samples.

Reference Value Evaluation of Urine Sediment in Indonesian Adult Population Using Automated Urine Analyzer

Locally established clinical laboratory reference value are required to interpret laboratory test results for screening, diagnosis, prognosis, determining retest criteria or as microscopic confirmation. The objective of this study is to establish urine sediments reference value by using automated urine flow cytometry, investigating erythrocyte, leukocyte, epithelial cells, types of epithelial cells, bacteria, casts, pathologic casts, crystals, yeast, sperm, and mucus in Indonesian population using Sysmex UF-4000. A cross sectional study was conducted in October 2018 – April 2019 at R. Said Sukanto National Police Hospital in Jakarta. The study involved 240 participants comprised of clinically healthy 120 males and 120 females aged 18-65, with normal urine chemistry, hematology, blood glucose, liver function (AST, ALT), and renal function (urea, creatinine). The reference value was reported in microliter (μL) or in High Performance Field (HPF) or Low Performance Field (LPF). Mann-Whitney test through MedCalc software was used to test significant differences with p value <0.05. This study observed significant differences between males and females in erythrocyte, epithelial cells, epithelial cell variety, bacteria, pathologic casts, and yeast”which are evidently higher in female patients. However, the mucus in LPF levels is found to be higher in male patients instead of the female, disparate than current reference value. Therefore, the reference value results were separated between the two groups in those aspects, whereas the results of other urine sediment characteristics studied were combined. As most reference value obtained are still within range of existing references, reference value established with Sysmex UF-4000 can be useful.

Lab-in-a-Cup (LiC): An autonomous fluidic device for daily urinalysis using smartphone

Since urine can be collected noninvasively, a wide range of biomarkers found in urine makes urinalysis well suited for continuous routine health screening. Although there has been amazing progress in automated urine analyzers, they are laboratory-centered and still suffer from labor-involved sample processing and analysis being infeasible for routine healthcare. To facilitate routine healthcare, this work presents a cost-effectively implemented lab-in-a-Cup (LiC) hybrid urinalyzer developed using a disposable plastic cup in association with conventional paper-based urine sensors. Since the sensor pad is precisely fixed with the bottom of the cup, the small gap between the sensor pad and cup surface leads to the limited diffusion of urine which results in the stable, reproducible, repeatable data and sample volume-irrelevant measurement. To characterize the urine sample in the cup, a smartphone application with an image recognition algorithm has been developed and applied that automatizes the entire analysis procedures enabling it for routine healthcare without relying on the manual color scheme. The device was successfully applied for investigating a number of urinary biomarkers such as glucose, pH, protein, and red blood cell (RBC) to a wider concentration covering their clinical ranges. While quantified, the proposed analyzer was found to significantly improve the reaction time and sample volume-dependent irregularities enhancing the colorimetric assessment of urine sensors as a major concern for biological samples. As a result, the user-friendly LiC device may suitably be applied as a near-patient urinalyzer.

Internal Quality Control Data of Urine Reagent Strip Tests and Derivation of Control Rules Based on Sigma Metrics.

BackgroundUrine reagent strip test (URST) results are semi-quantitative; therefore, the precision of URSTs is evaluated as the proportion of categorical results from repeated measurements of a sample that are concordant with an expected result. However, URSTs have quantitative readout values before ordinal results challenging statistical monitoring for internal quality control (IQC) with control rules. This study aimed to determine the sigma metric of URSTs and derive appropriate control rules for IQC.MethodsThe URiSCAN Super Plus fully automated urine analyzer (YD Diagnostics, Yongin, Korea) was used for URSTs. Change in reflectance rate (change %R) data from IQC for URSTs performed between November 2018 and May 2020 were analyzed. Red blood cells, bilirubin, urobilinogen, ketones, protein, glucose, leukocytes, and pH were measured from 2-3 levels of control materials. The total allowable error (TEa) for a grade was the difference in midpoints of a predefined change %R range between two adjacent grades. The sigma metric was calculated as TEa/SD. Sigma metric-based control rules were determined with Westgard EZ Rules 3 software (Westgard QC, Madison, WI, USA).ResultsSeven out of the eight analytes had a sigma metric >4 in the control materials with a negative grade (-), which were closer to the cut-offs. Corresponding control rules ranged from 12.5s to 13.5s.ConclusionsAlthough the URST is a semi-quantitative test, statistical IQC can be performed using the readout values. According to the sigma metric, control rules recommended for URST IQC in routine clinical practice are 12.5s to 13.5s.

LX-8000R and UriSed 2 fully automated urine analyzers comparison to manual microscopic examination.

BackgroundUrinalysis has an important place in evaluating kidney and urinary tract infections. Automated urine analyzers enhance productivity and turnover in laboratories and economize time and labor required for analysis. In the present study, we evaluated and compared analytic and diagnostic performance of UriSed2 with LX-8000R, which is a novel image-based automated urine sediment analyzer.MethodsA total of 178 urine samples sent to our laboratory were evaluated by the two urine analyzers and standard manual microscopy. Precision and comparison studies were done in accordance with CLSI guidelines.ResultsSensitivity assessment revealed similar outcomes with both UriSed2 and LX-8000R devices for erythrocyte count (RBC), whereas UriSed2 device yielded higher outcomes for leukocyte count (WBC) and epithelial cells (EPI) than LX-8000R analyzer. Specificity of UriSed2 for WBC and RBC was higher than that of LX-8000R device. According to Gamma statistics, both urine analyzers showed perfect consistency for WBC, RBC and EPI cell counts. Manuel microscopy revealed statistically significant correlation between LX-8000R and UriSed2 in terms of WBC and RBC. Manual evaluation by Bland-Altman analysis demonstrated lower WBC and RBC values and higher EPI as compared to both UriSed2 and LX-8000R devices. As the result of Passing-Bablok regression analysis, both devices were found to be inconsistent with manual microscopy.ConclusionsWe think that evaluation of automated urine analyzers will be more meaningful when they are evaluated together with urine samples and patient clinical findings in addition to comparing with manual microscopy.

Evaluation of the sysmex UF-5000 fluorescence flow cytometer as a screening platform for ruling out urinary tract infections in elderly patients presenting at the Emergency Department

In this study, we evaluated the performance of the flow cytometer-based Sysmex UF-5000 automated urine analyzer as a screening tool for ruling out urinary tract infections in elderly patients presenting at the emergency department. A total of 1119 unselected patient samples (including 544 samples from elderly patients) submitted for urine culture were included in this study. Samples were measured on UF-5000 and dipsticks and the results were compared with interpretation of culture results, which is the gold standard. We obtained a diagnostic sensitivity of 99% and specificity of 51% with a low rate of false negatives (0.2%) and a negative predictive value of 99% at 108 colony forming bacteria/L (CFB/L). A bacterial count ≥ 50x106/L or yeast like cells ≥ 25x106/L was used as the cutoff value. At this cutoff value, 30% of the urine cultures would have been redundant. This resulted in 35% false positive samples, mainly due to particle contamination or nongrowing bacteria. In comparison, at best, the dipsticks have a diagnostic sensitivity of 89%, a specificity of 52% and a negative predictive value of 92% at 108 CFB/L.

Establishment of the Risk Prediction Model for Significant Bacteriuria in Adult Patients with Automated Urine Analysis

Introduction: Urinary tract infections (UTIs) have been proven to be the most encountered bacterial infection in humans. We hope to establish a prediction model for significant bacteriuria by comprehensively analyzing the relevant parameters of age, gender, and urine automatic analysis data. Methods: A retrospective study was performed at Tai’an Central Hospital. All samples included in the study were tested for urine culture and urine automatic analysis. Data analysis was conducted with the SPSS. Results: The binary logistic regression module is used to establish the forecast formula, which gender, age, leukocyte count, bacterial count, leukocyte esterase, and nitrite were included. Receiver operating characteristic (ROC) curves showed that the area under ROC curve (AUC) of the prediction model was 0.878, bigger than the AUCs of the other 6 independent variables. The sensitivity and specificity of prediction model were 61.68 and 95.98%, respectively. The positive and the negative predictive values of the predictive model are 87.13 and 85.02%, respectively. Conclusions: The prediction formula obtained in our study can achieve good prediction effect for significant bacteriuria, which can effectively avoid the treatment delay or antibiotic abuse caused by the subjective judgment of doctors.

A comparison of automated urine analyzers cobas 6500, UN 3000-111b and iRICELL 3000 with manual microscopic urinalysis

ObjectivesMicroscopic examination is essential in urine analysis. This is a simple way to collect informative data but it is also labor-intensive, time-consuming, and requires experienced staff for accurate results and interpretation. Several automated urine analyzers have been introduced for urine analysis in medical laboratories. The aim of this study was to assess and compare the performance of the most common three automated urine analyzers, Cobas 6500, UN3000-111b and iRICELL 3000. MethodsA total of 100 routine urine samples were used in the study. Results from the three machines were compared with the routine procedure results including physical, chemical and sediment analysis. ResultsThere was good correlation of urine physical and chemical analyses between the three analyzers with an overall concordance level of more than 80%. For sediment analysis, the degree of concordance between manual analysis and the three instruments was very good to good for white blood cells, red blood cells and epithelial cells, and moderate for bacteria. There were fair to good agreements between manual microscopy and the three instruments, Cobas 6500, UN3000-111b and iRICELL 3000, for casts (Cohen’s kappa 0.42, 0.38 and 0.62, respectively). ConclusionsThe three automated urine analyzers showed similar performances and good correlation with manual microscopy. The results of this study indicate that automated urine analyzers could be used for initial urine testing to reduce high workloads and to save time, but manual microscopic analysis by experienced staff is still necessary to classify urine sediments for confirmation, especially in pathologic specimens.

Evaluation of Five Automated Urine Analyzers as Screening Instruments for Enhancing Diagnostic Efficiency in Urinary Tract Infection

Evaluation of Five Automated Urine Analyzers as Screening Instruments for Enhancing Diagnostic Efficiency in Urinary Tract Infection

Otomatik idrar analizörü lökosit parametresi performansının retrospektif değerlendirmesi ve idrar kültürü ile uyumu

Objective: Complete urinalysis (CUA) is one of the indispensable screening tests of clinical laboratories. The compatibility of this test with urine culture is of indispensable importance in the diagnosis and treatment of urinary tract infections. We aimed to evaluate the suitability of the leukocyte parameter measured in the microscopic units of the fully automated urine analyzers which replace traditional methods, by grouping them according to the results of chemical analysis. Materials and Methods: Leukocyte counts in the reported CUA results of 4685 outpatients and the results of 113 urine cultures studied on the same day were analyzed. Noncentrifugated urine samples were included in the analysis. Cells were digitally imaged by flow microscopy. Chemical analyzes were performed using dual wavelength reflectance method. Urine samples were evaluated after 24 hours of incubation. Results: High power field (HPF) values were recorded by grouping the leukocyte counts as negative, trace, 1+, 2+ and 3+. The arithmetic means of HPF values of the groups were calculated as 1.2, 2.1, 5.0, 11 and 208 white blood cell (WBCs/HPF). Bacterial growth was detected in 19 of 113 patients and no reproduction was observed in the remaining 94 cases. When results of microscopic examinations and chemical analysis were compared with the culture results, the analytical sensitivity, specificity, positive, and negative predictive values for microscopic urinalysis were 25%, 86%, 61.3%, and 58.3%, respectively. While, the analytical sensitivity, specificity, positive, and negative predictive values for chemical analysis of urine were 25.8%, 87.7%, 69.7%, and 51.4%, respectively. Conclusion: The workload of medical laboratories is increasing, and the use of urine autoanalyzers may be preferred for busy laboratories. In the diagnosis and follow-up of urinary tract infections, complete urinalysis by autoanalysers in which the harmony of their microscopy and chemical units are closely monitored, may reduce the need for unnecessary requests for urine culture, but it cannot replace urine culture.

Cut-off Values of Bacteriuria and Leukocyturia for the Diagnosis of Urinary Tract Infections in Pediatric Patients

The diagnosis of Urinary Tract Infection (UTI) in infants and children is often missed. There have been no studies ondiagnostic tests using automated urine analyzer in pediatric patients. This study aimed to determine the cut-off values ofbacteriuria and leukocyturia using the automated urine analyzer Sysmex UX-2000 to diagnose UTI with the gold standard ofautomated urine culture using VITEK 2 in pediatric patients at Dr. Moewardi Hospital, Surakarta. An observational analyticalstudy with the cross-sectional design was during August-October 2019 at the Clinical Pathology Laboratory and ClinicalMicrobiology Laboratory of Moewardi Hospital, Surakarta. Eighty-four patients sample were collected. This study'sdependent variable was the diagnosis of urinary tract infections in pediatric patients established with positive culture results(bacterial count of ≥ 105 CFU/mL urine). This study's independent variables were the number of urine bacteria (BACT) andthe number of urine leukocytes (WBC) from urinalysis using the Sysmex UX-2000 automated urine analyzer. A diagnostictest was used for data analysis. The best cut-off value for leukocyturia was 37 cells/μL with a 61.1% sensitivity, 63.6%specificity, a positive predictive value of 31.4%; a negative predictive value of 85.7; positive likelihood ratio of 1.64; negativelikelihood ratio of 0.595, and accuracy of 63%. The best cut-off for the number of bacteria was 143 cells/μL with a sensitivityof 66.7%; specificity of 71.2%, the positive predictive value of 38.7%, the negative predictive value of 88.7%; positivelikelihood ratio of 2.14; negative likelihood ratio of 0.432 and an accuracy of 70.2%. A cut-off of 37 cells/μL for leukocyturiaand 143 cells/μL for bacteriuria using an automated urine analyzer can be used for UTI screening in pediatric patients.

Atypical cells in sysmex UN automated urine particle analyzer: a case report and pitfalls for future studies

Abstract Objectives Sysmex UN series fully automated urine analyzer reports a series of research parameters besides routine parameters including the “atypical cells” parameter. An automated instrument in clinical use capable of detecting neoplastic cells of the urinary tract will have paramount significance. Case presentation A 73 years old male patient with a recurrent high grade urothelial carcinoma admitted to our urology outpatient clinic due to hematuria. Urinalysis showed +3 hemoglobin, +3 leukocyte esterase, 200/HPF red blood cells, 300/HPF white blood cells. The instrument also reported atypical cells (7.6/µL or 1.3/HPF) under the heading of “research parameters.” Presence of atypical cells was confirmed by the manual microscopy. The patient has undergone transurethral resection of papillary lesions and the pathology report confirmed a recurrence. On follow-up, atypical cells fell to 0.1/µL after 40 days. Conclusions This case report presents a patient with atypical cells in urine, detected by a fully automated urine analyzer. The atypical cells presented on the screen of the analyzer were confirmed by the manual microscopy. This presentation may influence future studies pertaining to the subject.

“Atypical Cell’’ Parameter in Automated Urine Analysis for the Diagnosis of Bladder Cancer: A Retrospective Pilot Study

“Atypical Cell’’ Parameter in Automated Urine Analysis for the Diagnosis of Bladder Cancer: A Retrospective Pilot Study

A Flow Cytometric and Cytochemistric Analysis of Urine to Detect Early Urinary Tract Infection

Introduction: Urinary tract infections (UTI) are infections affecting any part of the urinary tract and are most commonly caused by a multitude of bacteria. Most tests used these days to detect UTI are based on chemical test strips and cultures, both of which are labor and time-intensive. The aim of our study is to establish parameters that could detect UTI with high certainty. Material & Methods: The study was conducted in the Department of Pathology of Rajiv Gandhi Super Speciality Hospital, Delhi. The samples received between January to March 2017 were included in the study. All the samples were run in the Sysmex UX 2000, a fully automated urine analyzer. Results: A total of 236 patients were registered in this study. The study participants range from 4 years to 88 years with 56% males and 44% females. Out of these 21% were positive for UTI whereas 9% were inconclusive and 70% were negative. Cutoff values for white blood cells (WBC) and bacterial counts taken were 20.2 cells/µl and 143.2 cells/µl, respectively. Flowcytometric analysis of both WBC and bacterial cells showed high sensitivity (81%) as well as high negative predictive value (NPV) of 93%. Analysis of nitrites showed 97% specificity and 81% NPV, while leucocyte esterase showed 87% specificity and 92% NPV. Conclusion: Flow cytometry-based bacterial counts, total leucocyte counts, as well as nitrites and leucocyte esterase, could be used as screening tests for early as well as subclinical urinary tract infections and will reduce the need for urine culture.

Establishment of a reference procedure to measure urine-formed elements and evaluation of an automated urine analyzer

A standardized reference method is needed to accurately and precisely measure urine-formed elements (UFEs; red blood cells [RBCs], white blood cells [WBCs], and squamous epithelial cells [sECs]). We compared the results from a standard method with those from an automated analyzer. Trained technicians used standardized bright-field microscopy of fresh non-centrifuged urine samples, and disposable 1 µl chambers. Fifteen experienced technicians from 5 hospitals (3 per hospital) each performed 6 manual counts of 10 different native urine samples using a manual chamber and standard methods. The sEC counts were at least 50/µL, and the coefficient of variation (CV) was less than 14%; the RBC and WBC counts were at least 200/µL and the CVs were less than 7%. The same samples were also analyzed 6 times using automated analyzers. The means, CVs, and biases were determined. The median CVs for the manual measurements were 6.4% (WBCs), 6.6% (RBCs), and 12.7% (sECs). The CVs of the automated analyzer were 4.7% (WBCs), 5.6% (RBCs), and 9.2% (sECs). Biases between the automated and manual methods were −2.9% to 5.0%(WBCs), −0.8% to 8.8% (RBCs) and −2.8% to 9.4% (sECs). The count mean values and expanded uncertainties of these counts were (224.5 ± 15.0) cells/µL, (234.2 ± 16.2) cells/µL, and (61.5 ± 7.9) cells/µL, respectively. The standardized manual method for measuring UFEs had high precision and accuracy, making it a suitable reference method. Use of this reference method to calibrate an automated analyzer improved the accuracy of automated analysis.

Performance of automated urine analyzers using flow cytometric and digital image-based technology in routine urinalysis

The purpose of this study was to evaluate the analytical performances of Sysmex UF-5000 and Dirui FUS-200 and to compare the results with manual microscopy and between each other.Two hundred fifty urine samples were analyzed for evaluation. Mid-stream specimens were studied sequentially using Dirui FUS-200 and Sysmex UF-5000, and also with manual microscopy within one hour. The physical and chemical components of urinalysis, and sediment results were investigated.The precision results of the FUS-200 and UF-5000 for WBCs, RBCs, and ECs were acceptable. The both analyzers demonstrated good linearity (r > 0.97), with no carry-over. The comparisons of FUS-200 and UF-5000 with manual microscopy for RBCs, WBCs, and ECs on 250 samples exhibited good agreement with little bias (R > 0.780). Only, the moderate agreements were obtained for calcium oxalate for both analyzers (R = 0.512, and 0.648, respectively). The sensitivities of the FUS-200 and UF-5000 were 75.8% and 86.8%, with specificities of 92.3% and 87.8% for WBCs, for RBCs the sensitivities were 91.1%, and 84.4% with specificities of 82.2%, and 89.6% for both analyzers. Kappa values of the UF-5000 were higher than FUS-200 for WBCs, RBCs, ECs, and calcium oxalate.The FUS-200 and UF-5000 urine analyzers, are both accurate, very precise systems and can be safely used in clinical laboratories. However, due to the technological characteristics of the UF-5000 analyzer, its positive impacts on the morphologic recognition and enumeration of RBCs and WBCs should be taken into account, particularly in university hospital laboratories with high patient volumes.