UF-500i与IQ200尿沉渣分析仪检测管型的比较和评价

目的比较UF-500i与IQ200尿沉渣分析仪在检测管型中的敏感度、特异度和影响因素。方法采用UF-500i、IQ200尿沉渣分析仪和离心沉淀显微镜法分别检测门诊肾病患者晨尿标本,以人工镜检法作为标准对两种仪器敏感度、特异度进行分析。结果480份晨尿标本中,UF-500i尿沉渣分析仪敏感度为97．1％（68／70）,特异度为76．6％（314／410）;IQ200尿沉渣分析仪人工修饰前后敏感度分别为91．4％、100％（64／70,70／70）,特异度为70．5％／98．3％（289／410,403／410）。结论UF-500i与IQ200尿沉渣分析仪具有较高的管型检测灵敏度,但假阳性率高,均需人工复核以提高准确性。     

UF-50尿沉渣分析仪检测尿液有形成分干扰因素的探讨

目的 探讨UF-50 尿沉渣分析仪检测尿液有形成分的干扰因素.方法 随机抽取近期部分该院住院患者、门诊患者和体检人员尿液标本共1 200 份,利用UF-50 尿沉渣分析仪和尿沉渣镜检分别对尿液标本进行测定,对各检测项目的 结果进行分析比较.结果 UF-50尿沉渣分析仪能快速、准确地分析多个参数指标,已成为尿液检测标准化的基础,但由于存在许多复杂的干扰因素,部分检测结果会出现假阳性和假阴性.因此,UF-50尿沉渣分析仪可以作为一种有效的过筛工具,但不能代替尿沉渣显微镜检.结论 在临床尿液常规检查中,尿沉渣分析仪结合尿沉渣镜检,可以提高检测结果的准确度.     

UF-100型尿沉渣检测仪测定红细胞影响因素的研究

目的　探讨草酸钙、非晶形盐、细菌、酵母菌在UF 10 0型尿沉渣全自动检测仪分析中对红细胞检测的干扰。方法　采用UF 10 0型尿沉渣全自动检测仪分析法、干化学分析法、镜检法共分析了 2 6 34份住院患者尿液标本 ,并将三者结果进行了比较。结果　单纯或混合性草酸钙、非晶形盐尿液标本 ,UF 10 0检测红细胞结果假阳性率为 95 % ;菌尿UF 10 0检测红细胞结果的假阳性率为 2 8% ;含酵母菌尿液UF 10 0检测红细胞结果假阳性率为 4 0 % ;正常对照组UF 10 0检测红细胞结果假阳性率为 5 %。与对照组相比 ,三者差异均有显著性 (P <0 .0 1)。结论　在UF 10 0型尿沉渣全自动检测仪分析中 ,草酸钙、非晶形盐、菌尿、酵母菌对红细胞检测的结果干扰很大 ,这对尿液检测质量控制具有重要的意义。将这 3种方法联合应用 ,可以提高检测结果的准确度 ,具有较高的临床应用价值。     

UF-50尿沉渣分析仪与显微镜检测尿常规的比较分析

目的比较UF-50尿沉渣分析仪与镜检法尿常规检测的灵敏度与特异度。方法采集300例门诊和住院患者随机尿标本,分别采用UF-50尿沉渣分析仪和镜检法进行红细胞、白细胞检测,比较不同方法的检测结果。结果以镜检法作为参考方法,UF-50尿沉渣对红细胞的检测特异度低于镜检法(P<0.05),对白细胞的检测灵敏度低于镜检法(P<0.05)。结论 UF-50尿沉渣分析仪与镜检法尿常规检测各有优点与缺点,必要时可采用联合检测,以提高结果准确性。     

Clinical laboratory automated urinalysis: comparison among automated microscopy, flow cytometry, two test strips analyzers, and manual microscopic examination of the urine sediments

Urinalysis is one of the habitual clinical laboratory procedures, which implies that one of the largest sample volumes currently requires significant labor to examine microscopic sediments. Different analyzers currently used to perform this task have been compared with the manual microscopic sediment examination. The Atlas Clinitek 10 (Bayer Corporation, Diagnostics Division, Tarrytown, NY) and Urisys 2400 (Hitachi Science Systems Ltd., Ibaraki, Japan) test strips analyzers and two automated urinalysis systems, Sysmex UF-100 (Sysmex Corporation Kobe, Japan) and IRIS iQ200 (International Imaging Remote Systems, Chatsworth, CA), have been considered. We assessed the concordance between the results obtained from 652 freshly collected urine samples for erythrocytes (RBC), leukocytes (WBC), squamous epithelial cells (EC), nitrites/bacteria, and crystals using the methodologies mentioned. A principal components analysis was performed in order to examine the correlation between these parameters. Instrument accuracy was also assessed. The Spearman's statistic (p) showed an adequate agreement between methods for RBC (iQ200=0.473; UF-100=0.439; Atlas=0.525; Urisys=0.539), WBC (iQ200=0.695; UF-100=0.761; Atlas=0.684: Urisys=0.620), and bacteria/nitrites (iQ200=0.538; UF-100=0.647; Atlas=0.532; Urisys=0.561) counts. By applying the Wilcoxon and McNemar tests, a concordance degree was found between 82-99 and 52-95% for the values obtained from the two test strips analyzers considered and from the iQ200 and UF-100 systems, respectively. From these results, we can conclude that both test strips analyzers are similar and, on the other hand, that automated urinalysis is needed to improve precision and the response time; but sometimes manual microscopic revisions are required, mainly when flags, because of crystals, are detected.     

3种方法检测尿红细胞敏感度和准确性比较

目的比较UF-100尿沉渣全自动分析仪、尿液干化学分析仪与显微镜3种方法检测尿中红细胞（RBC）的敏感度和准确性。方法按要求收集2000份尿液样本,按仪器操作规程和尿沉渣显微镜检查规程,分别使用UF-100尿沉渣分析仪、GEB-600尿干化学分析仪和光学显微镜测定尿中RBC（每高倍视野大于3个为阳性样本）,采用SPSS10．0统计软件对所得数据进行统计学处理和配对资料卡方检验。结果3种方法检出RBC阳性率分别是：尿干化学法38．5％,UF-100全自动尿沉渣分析仪法33．0％,镜检法25．0％,尿干化学法及UF-100全自动尿沉渣分析仪法明显高于镜检法,三者间两两比较差异有统计学意义（P〈0．05）。结论3种方法联合检测可以提高尿中RBC检测的敏感度和准确性。     

尿红细胞3种检测方法的结果差异及影响因素分析

目的探讨3种方法（镜检与尿干化学法及UF-50全自动尿沉渣分析仪）测定尿红细胞结果的吻合性及其影响因素。方法采用镜检法和尿干化学法及UF-50全自动尿沉渣分析仪对同一尿液标本进行尿液红细胞测定。结果3种方法检出红细胞阳性率分别是：UF-50全自动尿沉渣分析仪法为29．4％,尿干化学法为23．2％,镜检法为21．6％。UF-50全自动尿沉渣分析仪法明显高于尿干化学法和镜检法。3种方法阳性率不尽相同,差异有统计学意义。结论3种方法测定尿红细胞结果有一定的差异,联合检测和结合临床资料综合分析才能更好地确定尿液中红细胞的有无及其来源（肾性与非肾性）。     

iQ200全自动尿液显微镜分析仪筛检尿路感染

目的探讨iQ200全自动尿液显微镜分析仪(简称iQ200)用于筛检尿路感染的可行性。方法214例中段尿标本在作病原体分离培养后立即用iQ200检测细菌(BACT)、小颗粒(ASP)和酵母菌(YST)等3项参数,用UF100全自动尿沉渣分析仪(简称UF100)检测细菌(BACT)和酵母菌(YLC)等2项参数。以培养结果作为金标准,应用受试者工作特征(ROC)曲线确定iQ200和UF100各项参数的最佳临床判断界值,评价各项参数的灵敏度、特异度、假阳性率、假阴性率和ROC曲线下面积。结果iQ200的BACT、ASP和YST的最佳临床判断界值分别为4.5/μl、2 404.5/μl和8.5/μl,灵敏度分别为73.3%、90.0%和90.5%,特异度为96.2%、46.9%和90.2%,假阳性率为3.3%、48.4%和8.4%,假阴性率为2.8%、0.9%和0.9%,ROC曲线下面积为0.862、0.698和0.946。UF100的BACT和YLC的最佳临床判断界值为4 657.6/μl、41.6/μl,灵敏度为76.0%、61.9%,特异度为76.8%、97.4%,假阳性率为17.8%、1.4%,假阴性率为5.6%、3.3%,ROC曲线下面积为0.821和0.795。结论iQ200用于筛检尿路真菌感染和革兰阴性杆菌感染具有一定的价值,但不能代替病原体的培养鉴定。     

Pediatric reference values for urine particle quantification by using automated flow cytometer: Results of a multicenter study of Italian urinalysis group

Objectives

The purpose of this Italian multicenter study was to define pediatric upper reference values for urine particle quantification by using automated flow cytometry.

Design and methods

Four hospital-based clinical laboratories participated in this multicenter investigation, which included a total study population of 161 Italian children aged from 1 to 12 years. Two laboratories used Sysmex UF-100 and analyzed 86 children, whereas the other two used Sysmex UF-1000i and analyzed 75 subjects. Particle quantification included the analysis of white blood cells (WBC), red blood cells (RBC), squamous epithelial cells (EC), transitional epithelial cells (TC), casts (CAST) and bacteria (BACT).

Results

The upper reference values in subjects tested with the Sysmex UF-100 were 9.7 WBC/μL, 10.1 RBC/μL, 7.5 EC/μL, 2.5 TC/μL, 0.7 CAST/μL and 3090 BACT/μL, whereas the upper reference values in subjects tested with the Sysmex UF-1000i were 10.5 WBC/μL, 8.3 RBC/μL, 7.2 EC/μL, 2.9 TC/μL, 0.7 CAST/μL and 48 BACT/μL. No statistically significant differences between genders were found in the value distribution of any of the parameters tested. Similarly, no statistically significant differences were observed between the two urine analyzers, except for BACT.

Conclusions

Automated analysis of urine particles appears a suitable means to optimize the workflow of routine urinalysis of children specimens. The upper reference limits for pediatric subjects obtained in this study were comparable to those previously reported in the literature, with no significant differences between genders and analyzers.     

IQ200ELITE尿沉渣分析仪检测红细胞的方法学评价

目的评价IQ200 ELITE尿沉渣分析仪的性能,探讨其临床应用价值。方法使用IQ200 ELITE尿沉渣分析仪和Fast-Read尿沉渣计数板计数血细胞悬液和尿样标本中红细胞数并进行统计分析。结果 IQ200检测红细胞的线性范围大致为7~3 800,批内精密度为3.8%,批间精密度为4.7%,日间精密度为5.6%,总重复性为4.91%,携带污染率在0.00%~0.31%之间,平均0.21%,与Fast-Read尿沉渣计数板计数红细胞数比较不存在明显恒定的系统误差,但易受小圆形草酸钙的干扰。结论 IQ200具有良好的线性,较宽的线性范围,精密度较高,携带污染率极低,不存在明显恒定的系统误差,可用于过筛检查和治疗监控,具有较高的临床应用价值。     

全自动尿沉渣仪分析法与显微镜法判断血尿来源的准确性比较

目的对比全自动尿沉渣分析仪分析法和显微镜法判断血尿来源的准确性,为临床参考提供数据资料。方法 206例血尿患者作为研究对象,其中肾小球病变患者101例,非肾小球病变患者105例。分别用UF1000i全自动尿沉渣分析仪（简称UF1000i）分析法和显微镜法分析尿液中红细胞（RBC）的形态,判断其来源并统计分析其检测性能的优劣。结果显微镜法的敏感性为88.1%,特异性为74.3%;UF1000i分析法的敏感性为92.1%,特异性为82.8%,2种方法检测结果的差异有统计学意义。受试者工作特征（ROC）曲线分析发现,显微镜法ROC曲线下面积（AUC）为0.869,UF1000i分析法AUC为0.928。结论 UF1000i分析法在肾小球性和非肾小球性血尿的鉴别中具有高敏感性和高特异性,其判断血尿来源的诊断价值优于经典相差显微镜法。     

Evaluation of FUS-2000 urine analyzer: analytical properties and particle recognition

This study evaluates the performance of microscopic part of a hybrid analyzer FUS-2000 (Dirui Industrial Co., Changchun, China), its analytical properties and particle recognition. The evaluation of trueness, repeatability, detection limit, carry-over, linearity range and analytical stability was performed according to Dirui protocol guidelines designed by Dirui Company to guarantee the quality of the instrument. Trueness for low, medium and high-value concentrations was calculated with bias of 15.5, 4.7 and ?6.6%, respectively. Detection limit of 5 Ery/μl was confirmed. Coefficient of variation of 11.0, 5.2 and 3.8% was measured for within-run repeatability of low, medium and high concentration. Between-run repeatability for daily quality control had coefficient of variation of 3.0%. Carry-over did not exceed 0.05%. Linearity was confirmed for range of 0–16,000 particles/μl (R²?=?0.9997). The analytical stability had coefficient of variation of 4.3%. Out of 1258 analyzed urine samples, 362 positive were subjected to light microscopy urine sediment analysis and compared to the analyzer results. Cohen’s kappa coefficients were calculated to express the concordance. Squared kappa coefficient was 0.927 (red blood cells), 0.888 (white blood cells), 0.908 (squamous epithelia), 0.634 (transitional epithelia), 0.628 (hyaline casts), 0.843 (granular casts) and 0.623 (bacteria). Single kappa coefficients were 0.885 (yeasts) and 0.756 (crystals), respectively. Aforementioned results show good analytical performance of the analyzer and tight agreement with light microscopy of urine sediment.     

全自动尿沉渣仪分析法与显微镜法判断血尿来源的准确性比较

目的对比全自动尿沉渣分析仪分析法和显微镜法判断血尿来源的准确性,为临床参考提供数据资料。方法 206例血尿患者作为研究对象,其中肾小球病变患者101例,非肾小球病变患者105例。分别用UF1000i全自动尿沉渣分析仪(简称UF1000i)分析法和显微镜法分析尿液中红细胞(RBC)的形态,判断其来源并统计分析其检测性能的优劣。结果显微镜法的敏感性为88.1%,特异性为74.3%;UF1000i分析法的敏感性为92.1%,特异性为82.8%,2种方法检测结果的差异有统计学意义。受试者工作特征(ROC)曲线分析发现,显微镜法ROC曲线下面积(AUC)为0.869,UF1000i分析法AUC为0.928。结论 UF1000i分析法在肾小球性和非肾小球性血尿的鉴别中具有高敏感性和高特异性,其判断血尿来源的诊断价值优于经典相差显微镜法。     

Consistency analysis of the Sysmex UF‐5000 and Atellica UAS 800 urine sedimentation analyzers

ObjectiveTo evaluate the consistency between the results of Sysmex UF‐5000 system and Atellica® UAS 800 Urine Sediment Analyzer.MethodsA 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.ResultsThe 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%.ConclusionTwo 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.     

Sysmex UF-1000i尿流式分析仪检测住院患者尿标本类酵母菌的临床评价

目的评价Sysmex UF-1000i尿流式分析仪检测尿标本类酵母菌的分析性能。方法应用尿流式分析仪检测我院住院患者尿标本,对仪器检测类酵母菌阳性尿标本进行镜检、培养鉴定;同时随机选择同期仪器检测阴性标本作对照。结合临床,判断患者尿路类酵母菌定植或感染。结果 2010年10月-2010年12月间共检测6019份尿标本,尿流式分析仪检测类酵母菌阳性127份,经培养证实82份为真阳性。同期仪器检测阴性标本121份中有12份培养阳性。以培养作为金标准,尿流式分析仪分析尿中类酵母菌试验敏感性为87.23%、特异性为70.78%、准确度为77.02%、阳性预测值为64.57%,阴性预测值为90.08%。菌种前三位的是以光滑念珠菌(43.40%)、白念珠菌(21.69%)、热带念珠菌(14.15%)。阿萨希毛孢子菌也存在一定比例(5.66%)。尿中类酵母菌真阳性患者多数患有多种基础疾病,以2型糖尿病(25.61%)、慢性泌尿系统疾病(18.29%)和颅脑脊髓损伤(17.07%)为主;实施的医疗措施以抗细菌药物(52.44%)、留置导尿管(35.37%)多见(P<0.05)。尿流式分析仪检测阴性而培养阳性12例患者均为尿路念珠菌定植。尿流式分析仪检测阳性并且培养阳性82例患者中,69例(84.15%)为类酵母菌尿路定植;13例(15.85%)为尿路感染,其中1(1.22%)例发展为热带念珠菌血症。结论 Sysmex UF-1000i尿流式分析仪对尿标本类酵母菌有较强的筛查价值。实验室应对仪器类酵母菌检测阳性标本进行镜检后确认。临床医师应对类酵母菌检测阳性患者结合其临床表现,采取不同的治疗措施。     

全自动尿沉渣分析仪Sysmex UF-1000i的性能评价

目的评价Sysmex UF-1000i全自动尿沉渣分析仪(简称Sysmex UF-1000i)的性能,以探讨其是否符合临床要求。方法按照实验室ISO15189要求,检测白细胞(WBC)计数、红细胞(RBC)计数、上皮细胞(EC)计数、管型(CAST)计数及细菌(BACT)计数5项指标的批内精密度、批间精密度、携带污染率、线性范围、准确度并验证生物参考区间。结果 Sysmex UF-1000i对白细胞(WBC)、红细胞(RBC)、上皮细胞(EC)、管型(CAST)、细菌(BACT)的低值质控批内精密度、高值质控批内精密度、低值质控批间精密度、高值质控批间精密度、低值质控准确度、高值质控准确度,以及RBC、BACT的携带污染率(分别为0.02%和0.00%)均符合厂家要求。WBC、RBC、BACT的线性相关系数r2分别为0.999 4,0.999 8,0.999 8,r2均不低于0.95,线性良好。结论 UF-1000i各项性能均符合ISO15189对性能评价的要求,可应用于临床尿液沉渣的检验。     

Urine particles analysis: Performance evaluation of Sysmex UF-1000i and comparison among urine flow cytometer,dipstick, and visual microscopic examination

Abstract

Introduction. Our objective was to evaluate a newly invented urine flow cytometer, and select an optimal strategy for urinalysis in clinical practice. Methods. The performance of UF-1000i was evaluated in both control material and patient samples. A total of 1631 specimens were collected and analysed by visual microscopy examination (VME), UF-1000i flow cytometer (Sysmex Medical Electronics Co, Kobe, Japan) and an automated dipstick reflectometer Clinitek Atlas (Bayer Corp, Elkhart, USA). Results. UF-1000i showed good imprecision performance for the main parameters in urine particles with CV values less than 20%. The results from UF-1000i correlated well with VME for erythrocytes (r = 0.96), leukocytes (r = 0.98), and epithelial cell (r = 0.84). The area under the receiver operating curve (AUC) was 0.879, 0.903, 0.783, and 0.817 respectively for erythrocytes, leukocytes, bacteria and CAST in UF-1000i. While in Clinitek Atlas, the AUC was 0.848, 0.803, 0.761, and 0.754 respectively. Sensitivity of combination of the two methods for screening remained at 98% as compared to VME alone, while reducing the visual review rate down to 40%. Conclusion. UF-1000i is capable of reproducible measurement of urine particles in the clinically relevant range and shows its advantage over Atlas. Combination of the two methods is an optimal strategy for urine sample screening.