RESUMEN
Several types of fastidious bacteria can cause tract infections. We evaluated the performance of counting fastidious bacteria using a Fully Automated Urine Particle Analyzer UF-5000. The results showed that UF-5000 counts fastidious bacteria in urine without the need for culture using measurement principles based on flow cytometry.
Asunto(s)
Infecciones Urinarias , Humanos , Infecciones Urinarias/microbiología , Bacterias , Citometría de Flujo/métodos , Orina/microbiologíaRESUMEN
PURPOSE: Culture-negative urine specimens can be rapidly screened by urine flow cytometry (UFC), while low positive predictive value (PPV) limits the clinical application. We explored the factors associated with a low PPV. METHODS: A total of 5095 urine specimens were analyzed with UFC and culture. Diagnostic performance of leukocytes, bacteria, and BACT-info flags was evaluated by sensitivity, specificity, PPV, and negative predictive value (NPV). The association of contaminated culture and squamous epithelial cell count and BACT-info flag was performed by logistic regression analysis. RESULTS: The NPVs of parallel combination of bacteria and leucocytes were 98.9% in males and 97.9% in females, and PPVs of serial combination were 86.6% and 77.8% in men and women, respectively. The PPV of Gram-negative flag was higher than that of Gram-positive flag. The proportions of contamination in the urine culture results of false positive specimens were 86.9% in males and 98.5% in females at the cutoff points of the serial combination, and these parameters were 53.2% in males and 85.6% in females for the Gram-positive flag. There was a statistically significant association between contaminated cultures and squamous epithelial cells count in females, but not in males. Associations between contaminated cultures and Gram-positive flags or Gram-pos/-neg flags were statistically significant, but there was no association between contaminated cultures and Gram-negative flags. CONCLUSIONS: A serial combination of leukocytes and bacteria may maximize PPV in the diagnosis of bacterial urinary tract infection by urine flow cytometry, and contamination is the main reason for a low PPV.
Asunto(s)
Infecciones Bacterianas , Infecciones Urinarias , Masculino , Humanos , Femenino , Valor Predictivo de las Pruebas , Citometría de Flujo/métodos , Infecciones Urinarias/microbiología , Urinálisis/métodos , Bacterias , Sensibilidad y Especificidad , Orina/microbiologíaRESUMEN
a Objectives: Urinalysis is one of the most common laboratory screening tests to detect problems in the renal and urinary system; however, they cannot detect atypical cells (Atyp.Cs). The Sysmex UF-5000, a fully automated urine particle analyzer, can detect Atyp.Cs via its Atyp.C parameter. This study aimed to compare the clinical value of the Atyp.C parameter with that of urine sediment microscopy. b Method: A total of 471 leftover urine samples were submitted to the Department of Clinical Laboratory at the University of Tokyo Hospital for urinalysis by manual sediment microscopy examination and UF-5000 Atyp.C analysis. c Result: Of 471 submitted samples, 117 were positive for Atyp.Cs by urine sediment and 354 samples were negative. The histological subtypes of the Atyp.Cs included 105 cases of suspected urothelial carcinoma cells, 10 suspected squamous carcinoma cells, and 2 of suspected adenocarcinoma cells. The Atyp.C values for the Atyp.C-positive and -negative groups were 2.64 ± 0.69 and 0.38 ± 0.16, respectively. The optimal Atyp.C cutoff value determined by the receiver operating characteristic curve analysis was 0.4/µL. The area under the curve was 0.856, with a sensitivity of 79.5% and specificity of 85.1%. Atyp.C values of the UF-5000 showed high predictive performance for Atyp.C-positive specimens identified by urine sediment microscopy. d Conclusions: This study shows that a combination of UF-5000 analysis and microscopic examination of urine sediment improves Atyp.C detection in urine sediment analysis. These results suggest that Atyp.C measured by UF-5000 could be a useful screening parameter in routine testing of urine samples.
RESUMEN
BACKGROUND: Our study aims to evaluate the performance of the combination of Sysmex urine dry chemistry analyzer UC-3500 and urine particle analyzer UF-5000 in screening bacterial urinary tract infection (UTI). METHODS: We analyzed 2000 urine specimens from patients with suspected UTI by using a urine dry chemistry analyzer (UC-3500) and a fully automated sediment analyzer (UF-5000). After being tested by the instrument, all specimens were sent to our clinical microbiology laboratory for culture. In addition, 600 urine specimens were selected to evaluate the accuracy of the six screening strategies established in this study. RESULTS: The consistency of UF-5000 bacterial classification and bacterial culture was fair (Kappa = 0.339). The counts of WBC and BACT elevated with sequential group designs (P < 0.001). The cut-off value of WBC was 32.20/µL for males (AUC, 0.942, 95%CI, 0.930-0.955) and 39.15/µL for females (AUC, 0.931, 95%CI, 0.914-0.948). The sensitivity and specificity of WBC were relatively higher than those of BACT. Strategy⣠and Strategy⥠in all six strategies had a good negative predictive value (NPV) which was 98.73%. CONCLUSION: UF-5000 bacterial classification cannot be used as a practical reference. 32.20/µL (male) and 39.15/µL (female) for WBC as well as 22.35/µL (male) and 127.25/µL (female) for BACT were used as cut-off values to effectively determine whether UTI occurs. WBC, BACT and LEU joint screening programs were suitable to rapidly and effectively exclude bacterial UTI.
Asunto(s)
Infecciones Bacterianas , Infecciones Urinarias , Humanos , Masculino , Femenino , Citometría de Flujo/métodos , Infecciones Urinarias/diagnóstico , Infecciones Urinarias/microbiología , Bacterias , Infecciones Bacterianas/diagnóstico , Infecciones Bacterianas/microbiología , Sensibilidad y Especificidad , Urinálisis/métodos , Recuento de LeucocitosRESUMEN
In this study, we tested the performance of the Sysmex UF-5000 system to detect yeast-like cell (YLC) counting to screen for candiduria. Urine samples were screened for leukocyte and yeast amount by flow cytometry and results were compared with fungal culture results. A total of 56,749 urine samples were enrolled in this study. Urine culture and urinalysis of YLC data were used to evaluate the performance of YLC in diagnosing candiduria. Different cut-off values (YLC. 5, 10, 20, 50, 100/µl) were evaluated. Youden index was used to determine the ideal cut-off value, and the highest was 0.95 with 5 YLC/µl. When the cut-off value for YLC is 5 cells/µl, 95.15% of the samples were "negative" with flow cytometry and culture (NPV:100%). In conclusion, detection of YLC by flow cytometer (Sysmex UF-5000) can be a rapid alternative method to exclude candiduria prior to urine culture.
Asunto(s)
Saccharomyces cerevisiae , Infecciones Urinarias , Humanos , Infecciones Urinarias/diagnóstico , Infecciones Urinarias/microbiología , Urinálisis/métodos , Citometría de Flujo/métodos , Orina/microbiología , Sensibilidad y EspecificidadRESUMEN
Background and objective: Urine culture is time consuming, which may take days to get the results and impede further timely treatment. Our objective is to evaluate whether the fast urinalysis and bacterial discrimination system called Sysmex UF-5000 may predict urinary tract infections (UTIs) (within minutes) compared with the clinical routine test in suspected UTI patients. In addition, we aimed to explore the accuracy of microbiologic information by UF-5000. Materials and Methods: Consecutive patients who were admitted from the emergency department at Queen Mary Hospital (a tertiary hospital in Hong Kong) from June 2019 to February 2020 were enrolled in the present study. The dipstick test, manual microscopic test with culture, and Sysmex UF-5000 test were performed in the urine samples at admission. Results: A total of 383 patients were finally included in the present study. UF-5000 urinalysis (area under the receiver operator characteristic curve, AUC=0.821, confidence interval, 95%CI: 0.767-0.874) outperformed the dipstick test (AUC=0.602, 95%CI: 0.550-0.654, P=1.32×10-10) for predicting UTIs in patients without prior antibiotic treatment. A significant net benefit from UF-5000 was observed compared with the dipstick test (NRI=39.9%, 95%CI: 19.4-60.4, P=1.36 × 10-4). The urine leukocyte tested by UF-5000 had similar performance (AUC) for predicting UTI compared with the manual microscopic test (P=0.27). In patients without a prior use of antibiotics, the concordance rates between UF-5000 and culture for predicting Gram-positive or -negative bacteriuria and a negative culture were 44.7% and 96.2%, respectively. Conclusions: UF-5000 urinalysis had a significantly better predictive value than the dipstick urine test for predicting UTIs.
Asunto(s)
Urinálisis , Infecciones Urinarias , Antibacterianos , Bacterias , Servicio de Urgencia en Hospital , Humanos , Sensibilidad y Especificidad , Urinálisis/métodos , Infecciones Urinarias/diagnóstico , Infecciones Urinarias/microbiologíaRESUMEN
OBJECTIVE: To evaluate the consistency between the results of Sysmex UF-5000 system and Atellica® UAS 800 Urine Sediment Analyzer. METHODS: A total of 636 random urine samples were collected from inpatients and outpatients from March to September 2021. Urine was collected for analysis by the Sysmex UF-5000, Atellica UAS 800 systems, and manual microscopic examination. The results of manual microscopy as the gold standard, the coincidence rate and false-negative rate of Sysmex UF-5000 and Atellica UAS 800 systems in the detection of red blood cells, white blood cells, and casts were calculated. RESULTS: The coincidence rates of red blood cells, white blood cells, and cast, crystals, and other sediment components for the Sysmex UF-5000 system were 85.37%, 87.89%, 91.67%, 88.36%, and 71.86%. The false-negative rates were 28.47%, 3.75%, 68.97%, 37.25%, and 30.63%. The coincidence rates of red blood cells, white blood cells, and cast, crystals, and other sediment components for the Atellica UAS 800 system were 85.06%, 90.25%, 59.12%, 91.67%, and 67.45% and the false-negative rates were 60.42%, 21.25%, 36.21%, 19.64%, and 35.80%. CONCLUSION: Two instruments are superior in the detection of red blood cells and white blood cells. The Atellica UAS 800 system with image review has a good coincidence rate in the identification of crystals and casts. The identification of various sediment components in urine by both instruments meets the laboratory requirements. Two instruments with different methodologies have their own characteristics, and we should reasonably use them according to the conditions of the laboratory.
Asunto(s)
Microscopía , Urinálisis , Recuento de Eritrocitos , Citometría de Flujo/métodos , Humanos , Recuento de Leucocitos , Leucocitos , Microscopía/métodos , Urinálisis/métodos , Orina/químicaRESUMEN
BACKGROUND: Automated urine sediment analysis has been developed to address the limitations of microscopic examination of dysmorphic red blood cells (RBCs). We evaluated the urinary RBC distribution (URD) parameter of a recently launched automated urinary flow cytometry analyzer, UF-5000 (Sysmex, Kobe, Japan), to differentiate glomerular hematuria (GH) from non-GH (NGH). METHODS: Samples submitted for urine sediment analysis from patients with hematuria (>20 RBCs/µL) were divided into derivation (N=156; 101 GH, 55 NGH) and validation cohorts (N=107; 60 GH, 47 NGH). The clinical diagnosis of GH or NGH was established based on clinical data review. Differences in UF-5000 parameters (URD, small RBC, lysed RBC, RBC-P70FSC, RBC-SF-FSC-W, mean forward-scattered light, and mean side-scattered light) between GH and NGH, and areas under the ROC curves (AUC) were analyzed in the derivation cohort. The derived ideal cut-off value was evaluated in the validation cohort. We applied the Kitasato criteria to compare the diagnostic performance. RESULTS: URD (%), differed significantly between GH and NGH (P<0.001) in the two cohorts. The AUC of URD was 0.814 and 0.806 in the derivation and validation cohorts, respectively. Using a cut-off of >20.1%, the sensitivity was 99.0%/89.4% and the specificity was 50.9%/63.3% in the derivation/validation cohort. When the Kitasato criteria were applied, the sensitivity and specificity were 80.2% and 52.7%, respectively. CONCLUSIONS: URD is a rapid, objective, and quantitative measure that can be used to differentiate GH and NGH.
Asunto(s)
Hematuria , Enfermedades Renales , Diferenciación Celular , Eritrocitos , Hematuria/diagnóstico , Humanos , Glomérulos RenalesRESUMEN
OBJECTIVES: Cellular analysis of body fluids (BFs) can assist clinicians for the diagnosis of many medical conditions. The aim of this work is the evaluation of the analytical performance of the UF-5000 body fluid mode (UF-BF) analyzer compared to the gold standard method (optical microscopy, OM) and to XN-1000 (XN-BF), another analyzer produced by the same manufacturer (Sysmex) and with a similar technology for BF analysis. METHODS: One hundred BF samples collected in K3EDTA tubes were analyzed by UF-BF, XN-BF and OM. The agreement was evaluated using Passing and Bablok regression and Bland-Altman plot analysis. The receiver operating characteristic (ROC) curves were selected for evaluating the diagnostic agreement between OM classification and UF-BF parameters. RESULTS: Comparison between UF-BF and OM, in all BF types, showed Passing and Bablok's slope comprised between 0.99 (polymorphonuclear cells count, PMN-BF) and 1.39 (mononuclear cells count, MN-BF), the intercepts ranged between 26.47 (PMN-BF parameter) and 226.80 (white blood cell count). Bland-Altman bias was comprised between 7.3% (total cell count, TC-BF) and 52.9% (MN-BF). Comparison between UF-BF and XN-BF in all BF showed slopes ranged between 1.07 (TC-BF and PMN-BF) and 1.16 (MN-BF), intercepts ranged between 8.30 (PMN) and 64.78 (WBC-BF). Bland-Altman bias ranged between 5.8 (TC-BF) and 21.1% (MN-BF). The ROC curve analysis showed an area under the curve ranged between 0.9664 and 1.000. CONCLUSIONS: UF-BF shows very good performance for the differential counts of cells in ascitic, pleural and synovial fluids and therefore it is useful to screen and count cells in this type of BF.
Asunto(s)
Líquidos Corporales , Recuento de Células/métodos , Recolección de Datos , Humanos , Neutrófilos , Proyectos de InvestigaciónRESUMEN
OBJECTIVE: The aim of this study was to evaluate the consistency and accuracy of all the parameters of the urine samples detected by two automated urine sediment analyzers from Sysmex Corporation. METHODS: Two automated analyzers and manual microscopy examined 1,059 urine samples. The sensitivity, specificity, positive predictive value, and negative predictive value were evaluated. The consistency of all the parameters was tested. The influencing factors of false positive and false negative samples were analyzed and compared. RESULTS: All the parameters had good specificity, negative predictive value, and coincidence rate (83.95%-99.61%). The RBC, WBC, and X'TAL analyzed by UF-5000 and UF-1000i exhibited good agreement (Kappa=0.597-0.784) with those by manual microscopy. The overall concordance rates of RBC and WBC were good (RBC: r=0.9842, CCC=0.9693; WBC: r=0.9955, CCC=0.9711). Among the influencing factors, mucus filament accounted for a large proportion, which mainly affected the detection of CAST. Concurrently, the false-positive factors of EC detection were reduced, and CAST did not affect the detection of EC. CONCLUSION: The parameters of the two instruments tested have shown high accuracy, consistency, coincidence rate, and low negative predictive value for RBC and WBC, which has ensured that UF-5000 and UF-1000i meet the clinical requirements for urine tests for disease screening. For the samples with poor consistency and false-positive factors, a conventional microscopic examination should be applied to verify the accuracy of the instrument detection.
Asunto(s)
Células Epiteliales/citología , Citometría de Flujo/instrumentación , Leucocitos/citología , Urinálisis/instrumentación , Orina/citología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Adulto JovenRESUMEN
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.
Asunto(s)
Citometría de Flujo/instrumentación , Infecciones Urinarias/diagnóstico , Adolescente , Anciano , Anciano de 80 o más Años , Carga Bacteriana , Niño , Servicio de Urgencia en Hospital , Femenino , Citometría de Flujo/métodos , Fluorescencia , Humanos , Masculino , Persona de Mediana Edad , Valor Predictivo de las Pruebas , Estudios Prospectivos , Sensibilidad y Especificidad , Infecciones Urinarias/orinaRESUMEN
OBJECTIVES: The microscopic examination of hematuria, a cardinal symptom of glomerulonephritis (GN), is time-consuming and labor-intensive. As an alternative, the fully automated urine particle analyzer UF-5000 can interpret the morphological information of the glomerular red blood cells (RBCs) using parameters such as UF-5000 small RBCs (UF-%sRBCs) and Lysed-RBCs. METHODS: Hematuria samples from 203 patients were analyzed using the UF-5000 and blood and urine chemistries to determine the cut-off values of RBC parameters for GN and non-glomerulonephritis (NGN) classification and confirm their sensitivity to the IgA nephropathy and non-IgA nephropathy groups. RESULTS: The UF-%sRBCs and Lysed-RBCs values differed significantly between the GN and NGN groups. The cut-off value of UF-%sRBCs was >56.8% (area under the curve, 0.649; sensitivity, 94.1%; specificity, 38.1%; positive predictive value, 68.3%; and negative predictive value, 82.1%), while that for Lysed-RBC was >4.6/µL (area under the curve, 0.708; sensitivity, 82.4%; specificity, 56.0%; positive predictive value, 72.6%; and negative predictive value, 69.1%). Moreover, there was no significant difference in the sensitivity between the IgA nephropathy and non-IgA nephropathy groups (87.1 and 89.8% for UF-%sRBCs and 83.9 and 78.4% for Lysed-RBCs, respectively). In the NGN group, the cut-off values showed low sensitivity (56.0% for UF-%sRBCs and 44.0% for Lysed-RBCs). CONCLUSIONS: The RBC parameters of the UF-5000, specifically UF-%sRBCs and Lysed-RBCs, showed good cut-off values for the diagnosis of GN.
Asunto(s)
Glomerulonefritis por IGA , Glomerulonefritis , Recuento de Eritrocitos , Eritrocitos , Glomerulonefritis/diagnóstico , Glomerulonefritis por IGA/diagnóstico , Hematuria/diagnóstico , HumanosRESUMEN
BACKGROUND: Automated flow cytometry-based urine analyzer is increasingly being used to identify and enumerate cells and particles in urine specimens. It measures electrical conductivity which could be transformed to osmolality. Using this machine, all urine specimens could be screened for osmolality without requiring a separate dedicated device. We evaluated the performance of the new instrument, the UF-5000 (Sysmex Corporation), in the measurement of urine osmolality. METHODS: The precision of urine osmolality measurement by the UF-5000 was evaluated for 20 days and 4 times a day for 2 concentrations. The linearity and detection capability were evaluated according to the Clinical and Laboratory Standards Institute guidelines. For comparison, 270 random urine specimens from patients were tested simultaneously using the UF5000 and the OsmoPro micro-osmometer (Advanced instruments). RESULTS: The laboratory-based coefficient variations were less than 5%. Urine osmolality using the UF-5000 has a verified linear range (y = 1.097x + 16.91, R2 = .997). Within the comparison analysis, the mean difference was not large (-7.72%) but each differences were largely dispersed with 95% limits of agreement (LoA) from -70.5 to 55.06%, and the mean absolute difference -28.3 mOsm/kg with 95% LoA from -295.13 to 238.45 mOsm/kg. Cohen's kappa value was 0.54 (95% CI, 0.45-0.63). CONCLUSIONS: The UF-5000 measured conductivity and generated an acceptable quantitative analysis of urine osmolality. When compared with the results of the freezing point depression method used by the OsmoPro, a percentage of the measured urine osmolality by the UF-5000 was outside the allowable limit.
Asunto(s)
Automatización de Laboratorios , Citometría de Flujo , Urinálisis , Automatización de Laboratorios/métodos , Automatización de Laboratorios/normas , Conductividad Eléctrica , Citometría de Flujo/métodos , Citometría de Flujo/normas , Humanos , Concentración Osmolar , Urinálisis/métodos , Urinálisis/normas , Orina/química , Orina/citologíaRESUMEN
BACKGROUND: Urinary tract infection (UTI) is one of the most common hospital-associated infectious. The traditional laboratory diagnosis method for UTI requires at least 24 hours, and it cannot provide the etiology basis for the clinic in time. The aim of our study is to develop a new method for pathogenic diagnosis of UTI by combining matrix-assisted laser desorption ionization time-of-flight mass spectrometry (MALDI-TOF MS) and UF-5000i from urine samples directly within 1 hour. METHODS: A total of 1,503 urine samples were collected from patients suggesting symptoms of UTI from August 2018 to January 2019. Each of these samples was divided into three aliquots. The first aliquot was used for conventional cleaning mid-stream urine culture; the second one for UF-5000i analysis to screen out the bacterial counts, which were more than 1×105 bacteria/mL. The third one was processed to bacterial purification and directly identified by the MALDI-TOF MS. RESULTS: In our study, 296 of 1,503 urine specimens were screened out by UF-5000i (bacterial pellets counts ≥105/mL). Compared the conventional culture-dependent method, the results of our methods were consistent in 249 of 263 (94.7%) cases, and they were both single-microorganism. Among 249 credible results, species-level identification (score ≥2.0) was contained 233 (233/249. 93.6%), 16 (16/249, 6.4%) samples scored between 1.7 and 1.99, and 14 (14/249, 5.6%) samples scored <1.7 or no peaks found. When there were 2 different kinds of bacteria in the urine, the result of MALDI-TOF MS was unreliable. CONCLUSIONS: MALDI-TOF MS combined with UF-5000i to identify the pathogenic bacteria in urine directly is a novel and reliable method and saves at least 23 hours relative to the current routine conventional method. Thus its rapid and accurate detection may provide the basis of etiology for clinical diagnosis of UTIs efficiently.
RESUMEN
BACKGROUND: This study evaluated the predictive power of Atyp.C (a parameter of UF-5000 flow cytometer) for patients with a suspected diagnosis of urothelial carcinoma. METHODS: We analyzed 163 urine specimens from 128 patients with suspected urothelial carcinoma using a fully automated fluorescence flow cytometry analyzer (UF-5000) and evaluated its performance on identifying atypical/malignant urothelial cells. From January 1, 2019 to April 4, 2019, all consecutive specimens for urinary cytopathology were enrolled. RESULTS: Of the specimens with urinary cytopathology, 67 specimens (41.1%) revealed abnormal findings in cytology analysis. Among them, 20 specimens (12.3%) were diagnosed as atypical urothelial cells, 26 specimens (16.0%) as suspicious for malignancy (S-malignancy), and 21 specimens (12.9%) as confirmed malignancy. The UF-5000 findings were positive in 59 specimens (36.2%); therefore, the agreement with cytopathology was 73.0%. Using follow-up histologic diagnosis of urothelial carcinoma with or without urinary tract cytology (UTCy) as a reference standard (suspicious and confirmed malignancy were the positive criteria for UTCy), the sensitivity was 59.0%, specificity was 82.1%, positive predictive value was 75.0%, negative predictive value was 68.8%, and the agreement was 71.1%. CONCLUSIONS: It is worth knowing and reporting that the Atyp.C assay may be used as an accessory test for patients with suspected urothelial carcinoma, based on its ability to identify high-risk patients who might need closer follow-up or additional medical treatment.
Asunto(s)
Carcinoma de Células Transicionales/diagnóstico , Citodiagnóstico/métodos , Citometría de Flujo/métodos , Urinálisis/métodos , Neoplasias de la Vejiga Urinaria/diagnóstico , Adulto , Anciano , Anciano de 80 o más Años , Carcinoma de Células Transicionales/orina , Citodiagnóstico/instrumentación , Femenino , Citometría de Flujo/instrumentación , Humanos , Masculino , Persona de Mediana Edad , Urinálisis/instrumentación , Neoplasias de la Vejiga Urinaria/orina , Adulto JovenAsunto(s)
Citometría de Flujo , Urinálisis/métodos , Orina/microbiología , Automatización , Bacterias/citología , Bacterias/aislamiento & purificación , Recuento de Colonia Microbiana , Errores Diagnósticos , Humanos , Recuento de Leucocitos , Urinálisis/instrumentación , Infecciones Urinarias/diagnóstico , Orina/citologíaRESUMEN
BACKGROUND: Automated cellular analyzers are expected to improve the analytical performance in body fluid (BF) analysis. We evaluated the analytical performance of three automated cellular analyzers and established optimum reflex analysis guidelines. METHODS: A total of 542 BF samples (88 cerebrospinal fluid [CSF] samples and 454 non-CSF samples) were examined using manual counting and three automated cellular analyzers: UniCel DxH 800 (Beckman Coulter), XN-350 (Sysmex), and UF-5000 (Sysmex). Additionally, 2,779 BF analysis results were retrospectively reviewed. For malignant cell analysis, the receiver operating characteristic (ROC) curve was used, and the detection of high fluorescence-BF cells (HF-BFs) using the XN-350 analyzer was compared with cytology results. RESULTS: All three analyzers showed good agreement for total nucleated cell (TNC) and red blood cell (RBC) counts, except for the RBC count in CSF samples using the UniCel DxH 800. However, variable degrees of differences were observed during differential cell counting. For malignant cell analysis, the area under the curve was 0.63 for the XN-350 analyzer and 0.76 for manual counting. We established our own reflex analysis guidelines as follows: HF-BFs <0.7/100 white blood cells (WBCs) is the criterion for quick scans with 100× magnification microscopic examination as a rule-out cut-off, while HF-BFs >83.4/100 WBCs or eosinophils >3.8% are the criteria for mandatory double check confirmation with 1,000× magnification examination. CONCLUSIONS: The three automated analyzers showed good analytical performances. Application of reflex analysis guidelines is recommended for eosinophils and HF-BFs, and manual confirmation is warranted.
Asunto(s)
Líquidos Corporales/citología , Recuento de Células/métodos , Área Bajo la Curva , Automatización , Recuento de Células/instrumentación , Citometría de Flujo , Humanos , Límite de Detección , Curva ROC , Reproducibilidad de los ResultadosRESUMEN
Introduction@#The traditional microscopic method is to visually count the elements in the urine, but it is difficult to distinguish between the cells because they are not stained. Sternheimer Malbin staining, on the other hand, contains a variety of dyes that help to distinguish elements in urine sediment, improve the differentiation between cell nuclei and cytoplasm, provide more information about cell shape and image, and make it easier to differentiate kidney disease. @*Objective@#To study the results of the reading of a fully automatic urine sediment analyzer of compared with the Sternheimer Malbin stained bright field microscope method.@*Research materials and methods@#In this study included 150 people who served the MJTH of the MNUMS received permission to participate in the research. The urine sample collected in accordance with the standard operating instructions was counted by a fully automated analyzer and stained with Sternheimer Malbin dye and counted red cells (RBC), white blood cells (WBC), epithelial cells (EC), and renal epithelium (RTEC) under a microscope using a Fuchs-Rosenthal chamber.@*Results@#23.3% (n=35) of the respondents were male, 76.6% (n=115) were female, and the average age was 44.3±11.6. There 16.6% (25)/9.3% (14) of the RBCs were counted in excess of the reference volume when analyzed under an microscope stained with an automated urine sediment analyzer and Sternheimer-Malbin dye. For each WBC method, 45.4% (68)/41 (61)% and EC 24.7% (37)/23.3% (35) were counted above the reference volume. 90% (135)/32% (48) of the total samples were counted in excess of the RTEC reference volume. Comparing the performance of the automatic urine sediment analyzer with the light microscope method, the sensitivity and specificity were RBC-99.8%/99.1%, WBC-99.3%/99.6%, EC-99.7%/99.2, and RTEC-99.1%/99.2%. False-positive and false-negative results were rated for each RBC-99.9%/99.1%, WBC-99.3%/99.6%, EC 99.8%/99.2%, and RTEC-99.7%/99.9%, respectively. The positive likelihood ratio was RBC, WBC, RTEC 1.0, or the test was useless, while the negative likelihood ratio was RBC was very different, WBC was slightly different, EC was very different, and RTEC was very different. Positive and negative predictive value indicators RBC-99.3%/99.4%, WBC-99.4%/99.4%, EC-99.4%/99.5, RTEC-99.2%/99.1%, optimality for RBC, WBC, EC 99.4%, RTEC -99.1%.@*Conclusion@#</br> 1. The results of an automated urine sediment analyzer and a bright field microscope stained by Sternheimer Malbin were similar for red blood cells, white blood cells, and epithelial cells, but different for renal tubular epithelial cells. </br> 2. The resuls UF-5000 analyzer and bright field microscope analysis using Sternheimer Malbin dye were comparable.
RESUMEN
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.
Asunto(s)
Citometría de Flujo/instrumentación , Urinálisis/instrumentación , Orina/citología , Automatización de Laboratorios , Eritrocitos , Citometría de Flujo/métodos , Humanos , Procesamiento de Imagen Asistido por Computador , Leucocitos , Microscopía , Sensibilidad y Especificidad , Urinálisis/métodosRESUMEN
Background While the introduction of automated urine analyzers is expected to reduce the labor involved, turnaround time and potential assay variations, microscopic examination remains the "gold standard" for the analysis of urine sediments. In this study, we evaluated the analytical and diagnostic performance of five recently introduced automated urine sediment analyzers. Methods A total of 1016 samples were examined using five automated urine sediment analyzers and manual microscopy. Concordance of results from each automated analyzer and manual microscopy were evaluated. In addition, image and microscopic review rates of each system were investigated. Results The proportional bias for red blood cells (RBCs), white blood cells (WBCs) and squamous epithelial cells in the automated urine sediment analyzers were within ±20% of values obtained using the manual microscope, except in the cases of RBCs and WBCs analyzed using URiSCAN PlusScope and Iris iQ200SPRINT, respectively. The sensitivities of Roche Cobas® u 701 and Siemens UAS800 for pathologic casts (73.6% and 81.1%, respectively) and crystals (62.2% and 49.5%, respectively) were high, along with high image review rates (24.6% and 25.2%, respectively). The detection rates for crystals, casts and review rates can be changed for the Sysmex UF-5000 platform according to cut-off thresholds. Conclusions Each automated urine sediment analyzer has certain distinct features, in addition to the common advantages of reducing the burden of manual processing. Therefore, laboratory physicians are encouraged to understand these features, and to utilize each system in appropriate ways, considering clinical algorithms and laboratory workflow.