Sysmex XE-5000自动血液分析仪的临床评价

目的 对Sysmex XE-5000全自动血细胞分析仪的主要性能进行评价.方法 对Sysmex XE-5000的精密度、线性范围、与镜检的相关性和交叉污染率进行测定,并与Sysmex XE-2100血细胞分析仪进行比较.同时,对微量血和体液模式进行了评估.结果 Sysmex XE-5000全自动血细胞分析仪精密度表现优异,重复性、稳定性好,线性范围宽,交叉污染率低.通过XE-5000分析,微量血与静脉血血细胞分析结果基本没有差异.体液模式脑脊液细胞计数、分类与人工镜检表现出良好的相关性.结论 Sysmex XE-5000全自动血细胞分析仪是一种较理想的血细胞分析仪.     

XE-2100全自动血细胞分析仪计数有核红细胞的准确性评价

目的探讨Sysmex XE-2100全自动血细胞分析仪计数有核红细胞的准确性。方法应用Sysmex XE-2100全自动血细胞分析仪筛查有核红细胞阳性的69例标本,用显微镜计数其外周血有核红细胞数量,比较血细胞计数及白细胞分类情况。结果 Sysmex XE-2100与显微镜计数法计数外周血有核红细胞数量有极好的相关性（r=0.992）,2种方法计数结果的差异无统计学意义（P〉0.05）。采用有核红细胞计数法,白细胞数较去除有核红细胞前减低（t检验,P〈0.05）,且淋巴细胞比例明显减低,而红细胞、血红蛋白及血小板均无明显变化（P〉0.05）。结论 Sysmex XE-2100全自动血细胞分析仪可灵敏、准确、快速地自动计数外周血有核红细胞,有效避免有核红细胞对白细胞总数及分类的干扰。     

Automated white blood cell counts in cerebrospinal fluid using the body fluid mode on the platform Sysmex XE-5000

Abstract

Background. The Sysmex XE-5000 offers automated quantification of red blood cells and white blood cells (WBCs) in body fluids, with differentiation of polymorphonuclear cells (PMNs) and mononuclear cells (MNCs). Methods. We evaluated automated WBC counting in cerebrospinal fluid (CSF) using the body fluid mode on the Sysmex XE-5000, comparing it with flow cytometry as the reference method, and also with manual counting by microscopy. Experimental analysis for linearity and limit of detection was performed by diluting isolated WBCs in cell-free CSF. To study the ability to discriminate between PMNs and MNCs, samples were spiked using MNCs separated from peripheral blood. Comparison of WBC counts between a counting chamber and the XE-5000 was performed for 198 CSF samples. Results. In the experimental set-up, within-run (CV 19%) and between-day imprecision (CV 15.3%) in quantitating total number of WBC on XE-5000 was acceptable for WBC counts ≥ 25 × 10⁶/L. Compared with expected cell counts, mean bias was + 2.6% for flow cytometry, + 5.5% for XE-5000 and ? 73.2% for manual counting. Differentiation between PMNs and MNCs was in concordance with flow cytometry. In comparisons of clinical CSF samples, overall agreement between the XE-5000 and manual counting was observed in 81% of the samples, but mean difference in WBC differentiation was higher for PMN (51.1 × 10⁶/L) than for MNC (7.95 × 10⁶/L). Conclusion. Despite limited precision at low WBC counts, XE-5000 could be a favourable alternative to the labour-intensive, time-consuming and less reliable manual counting and cuts turnaround times in routine CSF-based diagnosis.     

XE-2100血细胞分析仪嗜酸粒细胞异常散点图报警筛选疟原虫感染的研究

目的 利用Sysmex XE-2100血细胞分析仪提示的嗜酸粒细胞增高或无嗜酸粒细胞分类结果及异常散点图信息,探索能够快速、简便地检出疟原虫的方法.方法 用XE-2100血细胞分析仪进行血常规检测,对嗜酸粒细胞比值增高或无嗜酸粒细胞分类结果的标本进行显微镜检查,当镜检未发现嗜酸粒细胞异常时,继续镜检红细胞,查找疟原虫.结果 在1 501份仪器报警提示嗜酸粒细胞比值增高或无嗜酸粒细胞分类结果的标本中,经显微镜镜检发现有9份嗜酸粒细胞结果正常,与仪器报警不符.其中6份仪器报警提示嗜酸粒细胞增高,分类散点图中的嗜酸粒细胞与中性粒细胞间的间距变小;另外3份仪器报警提示白细胞分类散点图异常,嗜酸粒细胞与中性粒细胞间无间距,从而无分类结果.但9份标本均在红细胞中检出疟原虫的滋养体、裂殖体或配殖体.结论 当SysmexXE-2100血细胞分析仪提示嗜酸粒细胞增高或无嗜酸粒细胞分类结果,而未得到显微镜镜检证实时,则高度提示有疟原虫感染.此方法不仅能快速、简便地筛查疟原虫,而且对于防止漏检疟原虫有重要临床实用价值.     

未成熟粒细胞检测的评估及参考范围的建立

目的探讨血液分析仪定量检测不成熟粒细胞（IG）指数的临床应用;建立本实验室应用Sysmex XE-2100全自动血液分析仪进行IG检测的正常参考值范围。方法应用临床标本连续测定20次,观察其批内精密度;用2个水平质控物连续测定20 d,观察其批间精密度;分别应用血液分析仪和流式细胞仪对101例标本进行IG指数测定,对其结果进行相关性回归分析和一致性比较;对883例全血标本分别用血液分析仪进行自动幼稚粒细胞计数和手工推片染色后显微镜检分类,比较血液分析仪检测与显微镜镜检的一致性;以Sysmex XE-2100全自动血液分析仪和配套试剂盒测定766名健康者的IG值,以确立本室检测的参考范围。结果高、中、低值检测的批内精密度结果IG绝对计数的CV值分别为4.78%、5.35%、13.06%,IG百分率的CV值分别为3.82%、6.03%、14.54%;批间精密度2个水平的CV值分别为IG绝对值4.38%、5.13%;IG百分率4.3%、5.1%,均〈15%,在允许范围内。与流式细胞法比较具有良好相关性,相关系数（r）为0.916;与人工镜检比较的r为0.8903;年龄间比较各年龄组IG值间P均〉0.05,即年龄间差异无统计学意义;性别间比较P〈0.05,即性别间差异有统计学意义,分性别不分年龄建立本室IG检测的参考值范围为IG绝对值95%可信区间男（0,0.04×10^9/L）;女（0,0.02×10^9/L）。IG百分率95%可信区间男（0,0.5%）;女（0,0.4%）。结论临床应用血液分析仪定量检测IG方法可行,能为临床疾病的诊断和治疗监测提供实验室数据。各实验室应建立本实验室检测的参考值范围。     

Sysmex XE-2100全血细胞分析仪白细胞分类复检率探讨

目的探讨Sysmex XE-2100血细胞分析仪白细胞分类的复检率,进一步完善临床检验科的标准操作程序（SOP）文件。方法使用Sysmex XE－2100血细胞分析仪随机检测537例非血液科患者的外周血标本同时做显微镜检查（包括细胞形态观察和白细胞分类计数分类）,按照我国Sysmex XE-2100血细胞分析复检标准制定协作组制定的白细胞复检规则和显微镜检查阳性规则进行评估,计算出涂片复检率、真阳性、假阳性、真阴性、假阴性。结果根据Sysmex XE－2100血细胞分析复栓标准制定协作组的23条复检规则和涂片阳性规则对检测结果进行统计分析,复检率为15．27％（82／537）,真阳性率8．57％（46／537）,假阳性率6．70％（36／537）,真阴性率82．86％（445／537）,假阴性率1．86％（10／537）。结论SysmexXE-2100血细胞分析仪白细胞复检规则能有效提高检测效率,防止漏检和误检,可纳入本科室的SOP文件中。     

Sysmex XE-2100血液分析仪临床应用评价

目的：系统评价Sysmex XE-2100血液分析仪的性能。方法参照CLSI、ICSH相关文件,对XE-2100血液分析仪的精密度、携带污染率、稳定性、线性、可比性、白细胞分类相关性、正确度进行评价。结果 Sysmex XE-2100血液分析仪的精密度、携带污染率均在仪器要求范围内,标本在4℃保存条件下全血细胞计数与分类有良好的稳定性,WBC、RBC、HGB、PLT的线性范围宽,不同进样模式间的结果偏差均小于1%,与LH780、XT-1800i的检测结果具有良好的可比性,白细胞分类与人工分类具有良好的相关性,WBC、RBC、HGB、HCT、PLT正确度的偏移均小于1/4CLIA＆#39;88允许总误差。结论 XE-2100五分类血液分析仪的性能评价均达到了其技术指标,能满足临床对血液分析的需求。     

Measurement of total and differential white blood cell counts in synovial fluid by means of an automated hematology analyzer

We developed a rapid and accurate method for quantifying total and differential white blood cell (WBC) counts by pretreating synovial fluid with hyaluronidase and using an automated hematology analyzer. Forty-seven samples of synovial fluid that had been placed in blood-collection tubes containing ethylenediamine- N,N,N',N' -tetraacetic acid as an anticoagulant were treated with hyaluronidase at 37 degrees C for 10 minutes, and then the total and differential WBC counts were determined by means of the automated hematology analyzer. Results were compared with those achieved by traditional manual counting methods. For the automated method, the coefficient of variation values for within-run precision of the WBC count were 5.27%, 3.56%, and 3.01% at 0.54, 1.12, and 2.05 x 10(9) /L, respectively; the run-to-run coefficient of variation values was less than 10.0%. The total and differential WBC counts obtained by this automated method showed good correlation with those obtained by the hemocytometer method ( r = .998; P < .0001; regression formula, y = 0.986 x - 0.072). Bland-Altman plots indicated no significant discrepancy between the methods. Our evaluation supports the use of this automated hematology analyzer method to measure total and differential WBC counts, which should aid clinical diagnosis.     

Evaluation of the Sysmex Xe-2100 hematology analyzer in hospital use

The Sysmex XE-2100 (Sysmex Corp. Kobe, Japan) is a latest-generation hematology analyzer. Its optical and electrical measuring technology is improved by the addition of flux cytometry, fluorescence, and differential lysis. Its analytical performance in terms of precision, reproducibility, linearity, carryover, and time stability was found to be entirely satisfactory. In addition, the results of 500 complete blood counts and differentials correlated perfectly with those obtained by the Coulter STKS (Beckman Coulter, Villapointe, France). The comparison of 500 leukocyte differential count results analyzed in parallel with optical microscopy and the XE-2100 were surprising, and favorable to the XE-2100. This analyzer provides the user with an undeniable feeling of security concerning its reliability in detecting and identifying anomalies in the automated leukocyte differential count. With a sensitivity of 96%, a negative predictive value (NPV) of 98%, and a false-negative (FN) rate of 4%, the XE-2100 has perhaps reached the technological limits for a machine performing morphological recognition of normal and pathological blood cells.     

未成熟粒细胞检测的评估及参考范围的建立

目的探讨血液分析仪定量检测不成熟粒细胞(IG)指数的临床应用;建立本实验室应用Sysmex XE-2100全自动血液分析仪进行IG检测的正常参考值范围。方法应用临床标本连续测定20次,观察其批内精密度;用2个水平质控物连续测定20 d,观察其批间精密度;分别应用血液分析仪和流式细胞仪对101例标本进行IG指数测定,对其结果进行相关性回归分析和一致性比较;对883例全血标本分别用血液分析仪进行自动幼稚粒细胞计数和手工推片染色后显微镜检分类,比较血液分析仪检测与显微镜镜检的一致性;以Sysmex XE-2100全自动血液分析仪和配套试剂盒测定766名健康者的IG值,以确立本室检测的参考范围。结果高、中、低值检测的批内精密度结果IG绝对计数的CV值分别为4.78%、5.35%、13.06%,IG百分率的CV值分别为3.82%、6.03%、14.54%;批间精密度2个水平的CV值分别为IG绝对值4.38%、5.13%;IG百分率4.3%、5.1%,均<15%,在允许范围内。与流式细胞法比较具有良好相关性,相关系数(r)为0.916;与人工镜检比较的r为0.8903;年龄间比较各年龄组IG值间P均>0.05,即年龄间差...     

Sysmex XN全自动血细胞分析仪在体液细胞计数及分类中的应用

目的评价Sysmex XN全自动血细胞分析仪体液模式在脑脊液和胸腹水标本细胞计数及分类计数中的应用价值。方法收集2019年7-8月该院住院患者体液标本341例,其中脑脊液标本138例及胸腹水标本203例,应用Sysmex XN全自动血细胞分析仪(仪器法)和改良牛鲍计数板(手工法)分别分类计数,对两种方法所测结果进行比较。结果仪器法与手工法对脑脊液标本有核细胞计数及红细胞计数一致性较好(ICC=0.985、0.994,均P<0.05),仪器法与手工法对脑脊液标本有核细胞分类计数中单个核细胞及多个核细胞计数一致性较好(ICC=0.917、0.946,均P<0.05);仪器法与手工法对胸腹水标本中有核细胞计数及红细胞计数一致性较好(ICC=0.960、0.996,均P<0.05);仪器法与手工法对胸腹水标本有核细胞分类计数中单个核细胞、多个核细胞及间皮细胞计数一致性较好(ICC=0.894、0.937、0.758,均P<0.05)。结论Sysmex XN全自动血细胞分析仪体液检测模式与手工法结果有较好的一致性,其操作简单、迅速,结果准确、可靠,重复性好,在体液细胞检测中具有较高的临床应用价值。     

Evaluation of the XE-5000 for the automated analysis of blood cells in cerebrospinal fluid

ObjectivesCounting of cells in cerebrospinal fluid is an important clinical laboratory test and elevated white blood cell counts in cerebrospinal fluid are frequently seen in CNS disorders. Quantification of red blood cell concentrations in CSF may help to interpret certain diagnostic constellations and may result from subarachnoid haemorrhage, surgical procedures or contamination due to traumatic puncture. Table top analyser XE-5000 (Sysmex, Norderstedt, Germany) offers, beside its use as a haematology analyser, a protocol for the quantification of red and white blood cells in body fluids such as CSF including the differentiation between polymorphonuclear and mononuclear cells. A detection limit of 1 cell/mm³ would render this device suitable for automated CSF analysis.Design and methodsWhite blood cell counting was compared between Fuchs–Rosenthal counting chamber and XE-5000 in 273 routinely collected lumbar and ventricular CSF samples. Red blood cell counting was compared between UF-100 and XE-5000. Differentiation was performed on a slide stained after Pappenheim and compared to the differential count of the XE-5000.ResultsLinearity was established between 1 and 10,000 cells/mm³ for white blood cells and between 1000 and 1 ? 10³ particles/mm³ for red blood cells. Functional sensitivity was established at 20 cells/mm³ for white blood cell counting and at 1000 particles/mm³ (lowest reported concentration) for red blood cell counting. When comparing between microscopic and automatic white blood cell counts no statistically significant slope and offset were detected in lumbar CSF samples while a significant slope and offset were detected when comparing ventricular CSF samples. Most patients were classified correctly according to their WBC count (non-pathologic, mildly, moderately, and highly elevated) by both methods although more patients had pathologic white blood cell counts on XE-5000. A significant slope and offset were detected when comparing red blood cell counts between UF-100 and XE-5000.ConclusionsIn summary despite its high imprecision at low white blood cell counts (< 20 particles/mm³) most patients were classified correctly and therefore XE-5000 is suitable for automated quantification of white blood cells in cerebrospinal fluid in a defined diagnostic setting. This could significantly improve automation in the relatively time- and manual work-intensive field of cerebrospinal fluid diagnostics. However, careful review of plausibility of the results continues to be compulsory.     

Urine flow cytometer quantification of leukocytes in samples containing a large proportion of lymphocytes

OBJECTIVE: We compared leukocyte counts obtained by cytometric analysis and Fuchs-Rosenthal (FR) chamber counting in different proportions of lymphocytes (Lym%) suspensions and cerebrospinal fluid (CSF). DESIGN AND METHODS: UF-100 (UF) was evaluated. For preparation of cell suspensions, gradient density centrifugation method was used. RESULTS: The regression equation for UF and FR chamber counting of the cell suspensions was y=0.88x+18.8 WBC/microL (r=0.832, n=106). For a few high Lym% samples, markedly underestimated WBC counts were obtained by UF. CONCLUSIONS: Underestimated WBC count is due not to systematic error but to random error. Counts of the "other" population by UF may be useful for detection of underestimated samples.     

XE-2100血液分析仪两种血小板计数方法的准确性在血液疾病中的观察

目的观察XE-2100血液分析仪电阻抗法(PLT-I)和光学法(PLT-O)计数血小板的准确性以及与某些血液疾病的关系。方法检测XE-2100血液分析仪计数血小板的精密度并采用50名正常人和150例血液病患者的样本,用PLT-I法、PLT-O法和手工显微镜法同时计数血小板,以手工显微镜法结果为参考。结果XE-2100血液分析仪PLT-I法和PLT-O法计数血小板(低、中、高值)有较好的重复性,变异系数(CV)均<4.0%。健康者在XE-2100上用PLT-I法和PLT-O法计数血小板与显微镜法比较差异无统计学意义(P>0.05)。血液性疾病患者PLT-O法计数血小板与显微镜法比较差异无统计学意义(P>0.05),但PLT-I法计数血小板与显微镜法比较差异有统计学意义(P<0.05)。结论Sysmex XE-2100血液分析仪在分析血液病患者的血小板时,应以PLT-O法测定结果为好,但在仪器报警时还须用显微镜法复核。     

三分类血细胞分析仪的筛查与镜检标准的制定

目的：评价Coulter三分类血细胞分析仪对门、急诊患者的筛查效果；以及血涂片镜检标准的制定对三分类血细胞分析仪的补充作用。方法：对60例门、急诊患者的血液标本同时进行CoulterA^c．T diff^TM及Sysmex XE-2100血细胞分析仪全血细胞分析；对76例门、急诊患者的血液标本同时进行Coulter A^c．Tdiff^TM三分类及人工分类。结果：Coulter A^c．T diff^TM与Sysmex XE-2100血细胞分析仪全血细胞分析，包括WBC、RBC、Hb及Pit两者相关性较好（r〉0．90）；Coulter A^c．T diff^TM三分类与人工分类结果比较，中性粒细胞镜检法明显低于仪器法（P〈0．001），淋巴细胞镜检法明显高于仪器法（P〈0．001），中间细胞两种方法差异无显著性（P〉0．05）；中性粒细胞和淋巴细胞仪器法与镜检法相关性良好（r〉0．95），而中间细胞两者不相关（r〈0．1）。结论：使用三分类血细胞分析仪进行全血细胞分析包括WBC、RBC、Hb及Pit结果可信，可提高工作质量和效率；而三分类血细胞分析仪对白细胞分类的筛查作用有限，必须制定严格的显微镜复检标准，才能防止血液病患者的漏诊或误诊。     

XE-5000血细胞分析仪计数有核红细胞的性能评价

目的探讨SysmexXE．5000血细胞分析仪自动计数外周血有核红细胞（NRBC）的方法学特点,评价其临床应用价值。方法评析其重复性、线性范围、携带污染率,并对697份静脉血标本作常规测定,评价其对NRBC的报警、定量测定,并与手工涂片法进行对照。结果XE．5000血液分析仪测定NRBC的重复性较好,线性范围较广,携带污染率较小。以显微镜复检为金标准,XE．5000与显微镜计数法计数外周血中NRBC数量有极好的相关性（r=0．997）,其有核红细胞报警的灵敏度为100％,特异度为85．1％。结论SysmexXE．5000血细胞分析仪可灵敏、准确、精密地自动计数外周血中NRBC,适合临床检测NRBC。     

Evaluation of white blood cell count in peritoneal fluid with five different hemocytometers

ObjectivesEvaluation of automated flow cytometric analysis of white blood cell (WBC) count in peritoneal fluids.MethodsOne hundred peritoneal fluids were analyzed with manual microscopy, Sysmex XE-2100 and XE-5000, Siemens Advia 2120, Mindray BC-6800, Abbott Sapphire.ResultsHigh correlations (0.978 to 0.999) and modes biases (? 132 to 80 WBC/mm³) were found. Agreement at septic peritonitis cutoff ranged between 96% and 99%.ConclusionsThese hemocytometers display acceptable performance for WBC screening in peritoneal fluids.     

应用CLSI系列文件对XE-2100全自动血细胞分析仪进行性能验证及评价

目的对SYSMEX XE-2100全自动血细胞分析仪性能进行验证及评价。方法参考美国临床和实验室标准化协会（CLSI）系列文件和相关文献,结合工作实际,对XE-2100的精密度、正确度、可报告范围、携带污染率、仪器间的比对等分析性能进行验证和评价,并将实验结果与卫生部临检中心的要求进行比较。结果 Sysmex XE-2100的本底计数均达到厂商设计规定的要求,检测白细胞、红细胞、血红蛋白含量、红细胞压积、血小板五项精密度、正确度、线性范围良好,携带污染率低;其白细胞分类计数与显微镜分类的相关性不同细胞有差异。结论 Sysmex XE-2100分析性能良好,可以较好的满足临床血液常规检测要求,在批量筛检的基础上需要结合显微镜复检。     

对全自动血液分析仪白细胞计数范围复检规则的确立与验证

目的确立、验证Sysmex XE-2100全自动血液分析仪（简称XE-2100）白细胞（WBC）高、低值的最佳复检范围。方法将WBC〈4.0×109/L及WBC〉18×109/L的663例非血液病住院患者的样本分为2组,即高值组和低值组。其中高值组又分为A组（18.00～22.00×109/L,共148份）、B组（22.01～30.00×109/L,共164份）;C组（〉30.00×109/L,共74份）。低值组分为A＇组（1.00～2.00×109/L,共90份）;B＇组（2.01～3.00×109/L,共92份）;C＇组（3.01～4.00×109/L,共95份）。对上述各组进行检测分析,以中华人民共和国卫生行业标准——白细胞分类计数参考方法为标准,通过受试者工作特征（ROC）curve曲线找出仪器检测WBC最佳复检范围,并对其进行验证。结果 A组ROC曲线下面积为0.820,当WBC为21.05×109/L时其灵敏度为1.0、特异度为0.536。B组曲线下面积为0.749,C组曲线下面积为0.329。A＇组曲线下面积为0.689,B＇组曲线下面积为0.825,当WBC为2.45×109/L时其灵敏度为1.0、特异度为0.317。C＇组曲线下面积为0.983。验证结果：当WBC在2.45×109/L时无仪器警示标志的共28例,其中2例为假阴性,均为嗜碱粒细胞〉2,无重要临床意义;有警示标志的7例,其中1例为假阳性。当WBC为21.0×109/L时无仪器警示标志的共33例,其中只有1例假阴性也是嗜碱粒细胞〉2,有警示标志的7例其中3例为假阳性。结论 XE-2100的警示系统可以为复片提供有价值的信息,但血细胞计数范围的高低值也是不容忽略的复检因素。XE-2100在WBC〈2.50×109/L及WBC〉21.00×109/L时分类误差较大,即便无警示标志的出现依然需进行血细胞显微镜复检,以免造成漏诊。     

XE-5000研究参数白细胞分类结果与镜检对比

目的 探讨XE-5000全自动血细胞分析仪白细胞不能分类时研究参数中白细胞分类计数的准确性.方法 选择XE-5000白细胞不能分类的血液病患者66例和非血液病患者66例,分别进行涂片染色显微镜镜检分类.对XE-5000研究参数中白细胞分类结果与镜检结果进行相关性分析,比较两者结果的关系.结果 血液病组中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞和嗜碱性粒细胞相关系数分别为0.933、0.959、0.654、0.846和0.417(P<0.01).非血液病组中性粒细胞、淋巴细胞、单核细胞、嗜酸性粒细胞和嗜碱性粒细胞相关系数分别为0.882、0.908、0.416、0.420(P<0.01)和0.069(P>0.05).两种方法相比较,中性粒细胞、淋巴细胞呈高度正相关,单核细胞、嗜酸性粒细胞呈中度正相关.结论 XE-5000全自动血细胞分析仪研究参数中白细胞分类结果可靠,具有准确、简便、快速等优点,为分类提供一个可行方法,临床可参考研究参数分类结果出报告.