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。     

IQ200尿有形成分分析仪性能评估

目的对IQ200尿有形成分分析仪的性能进行验证,并将该仪器和人工显微镜镜检法结果比对。方法共收集250份新鲜尿液标本,分别采用人工显微镜镜检法和IQ200尿有形成分分析仪进行检测。评估该仪器检测尿有形成分的批内精密度、批间精密度、携带污染率、线性范围等性能指标,并对仪器与人工显微镜镜检法计数结果的相关性和一致性进行评价,利用受试者工作特征曲线(ROC曲线)计算各项参数的灵敏度、特异度及准确度。结果IQ200尿有形成分分析仪检测标本的批内精密度、批间精密度、线性范围以及携带污染率等性能指标满足厂家声明的要求。IQ200尿有形成分分析仪与人工显微镜镜检法检测红细胞(RBC)、白细胞(WBC)、上皮细胞(SQEP)结果的相关系数分别为0.945、0.949、0.950。仪器检测RBC、WBC、SQEP的灵敏度较高,管型(CAST)、真菌(YST)、结晶(CRY)的灵敏度较低;所有项目的特异度均较好,但检测WBC、SQEP、CRY的特异度高于RBC、CAST、YST;检测RBC、WBC、SQEP的准确度均高于90%,其ROC曲线下面积分别是0.947、0.974、0.980。结论IQ200尿有形成分分析仪的性能验证结果符合质量要求,对RBC、WBC、SQEP的诊断性能优于CAST、YST、CRY,可用于临床尿液标本初筛,但仍然要与人工显微镜镜检相结合以确保结果的准确性。     

Development and evaluation of a six-channel automated analyser for 24-h urine specimens

A system has been developed for the analysis of 24-h urine collections for sodium, potassium, calcium, phosphate, urea, and creatinine, using a six channel AutoAnalyzer for the analysis,and a computer for calculating the results and producing cumulative reports.     

Evaluation of Aution Max AX-4280 automated urine test-strip analyser.

Aution Max AX-4280, an automated urine test-strip analyser, was evaluated in three centres. Method comparison, imprecision, carry-over, linearity, detection limit and drift studies were performed for glucose, protein, blood and leukocytes using Uriflet S 9UB strips. These strips enable measurement of pH, glucose, protein, blood, leukocytes, ketones, bilirubin, urobilinogen and nitrite. Specific gravity is determined by the refractive index method. Within-run and between-day imprecision, assessed using pooled urines and quality control materials, were good. No drift over 24 h or sample carry-over was observed. Method comparison with quantitative methods for glucose, protein and specific gravity yielded good correlations. Ascorbate negatively interfered with haemoglobin, glucose and nitrite measurements. Acetylsalicylic acid lowered pH, the effect being greatest when protein was absent. During the assessment period no malfunction or breakdown was reported. The Aution Max is easy to use and needs minimal maintenance.     

IQ 200全自动尿沉渣分析仪与人工镜检的比较和评价

目的对IQ200全自动尿沉渣分析仪与人工镜检这两种方法进行比较和评价。方法随机收集102份尿液标本,用IQ200全自动尿沉渣分析仪与人工镜检对其中的红细胞、白细胞、上皮细胞、结晶等进行计数,然后再对数据进行比较分析。结果IQ200尿液分析结果与镜检结果符合率：红细胞为84.31%,白细胞为86.27%,上皮细胞为91.18%,结晶为87.25%。灵敏度：红细胞为95.24%,白细胞为92.86%,上皮细胞为94.44%,结晶为92.11%。特异度：红细胞为78.33%,白细胞为78.26%,上皮细胞为90.48%,结晶为84.38%,IQ200携带污染率为0。尿液中某些草酸钙结晶和真菌孢子会干扰IQ200对红细胞的检测。结论IQ200全自动尿沉渣分析仪依然无法代替人工镜检,需与显微镜检查联合应用以提高检验质量,保证结果的准确度。     

Novel aspects in the evaluation of an automated blood group analyser

Background: In contrast to other studies evaluating machines by testing a great number of samples, we focused here on the sensitivity and on the influence of possible disturbing factors on automated blood group testing. Materials and Methods: As the gelcards of the DiaMed‐ID Micro Typing System are well known, this study examines reading and interpretation of the gelcards by the automated analyser Techno TwinStation. The results of automated reading were compared with visual reading of the gelcards taken out from the machine. Results: The sensitivity, tested by the titers of some complete and incomplete antibodies, was at least the same for automated as for visual reading. Samples with weak antigens were well recognised by the analyser. Mixed field agglutinations were recognised as questionable results by automated reading up to a relation of 1 : 10 for the most part. Antibody screening and reverse typing were not influenced by hyperbilirubinaemia, whereas in lipemic and haemolytic samples doubtful results were reported. Conclusion: Interpretation of the results by the automated analyser Techno TwinStation may be disturbed in some difficult samples, but in most of these cases the analyser reports not a false, but a doubtful result, thus triggering visual reading by the operator.     

人工镜检与科宝XS全自动尿沉渣分析仪及IQ 200尿沉渣分析仪的比较和评价

目的探讨科宝XS全自动尿沉渣分析仪（简称科宝XS）、IQ200全自动尿沉渣分析仪（简称IQ 200）与标准人工镜检的一致性,同时观察科宝XS和IQ 200检测的重复性。方法同时用科宝XS、IQ 200及FAST-READER SY9502双画格细胞计数板对129例患者尿液标本进行尿沉渣定量计数（红细胞、白细胞、上皮细胞）,比较3种方法的结果。结果以FAST-READER SY9502双画格细胞计数板手工镜检法为比对金标准,科宝XS检测红细胞、白细胞、上皮细胞的灵敏度（83.5%、90.1%、89.8%）、阴性预测值（60.5%、89.2%、94.1%）均高于IQ200检测结果（灵敏度：66.9%、57.7%、18.4%;阴性预测值：43.3%、65.9%、66.8%）（P〈0.05）。科宝XS红细胞、白细胞、上皮细胞的批内CV（11.01%、10.54%、25.61%）虽低于IQ200批内CV（13.07%、12.54%、35.08%）,但差异无统计学意义（P〉0.05）。科宝XS检测结果与人工镜检法的总符合率及一致性检验Kappa值高于IQ200。结论相对于IQ200,科宝XS表现出更佳的检测性能,与人工镜检的符合率更高,符合临床实验室的检查需要。     

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。     

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、2404．5／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4657．6／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。     

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。     

External evaluation of LIAISON tumour marker assays on the fully automated chemiluminescent LIAISON immunoassay analyser

The LIAISON immunoassay analyser was tested in a multicentre evaluation performed by 8 laboratories. The analytes evaluated were CA 15-3, CA 19-9, CA 125II, AFP, CEA, NSE and PSA. Excellent results were obtained for within-run and between-run precision with most assays showing within-run CVs < 5% and between-run CVs between 4 and 8%. The linearity of all assays was acceptable, however, for PSA, NSE and CA 19-9 a recovery > 110% was obtained for some of the samples tested. None of the assays revealed a high-dose hook effect. Method comparisons were performed by using the routine method of the respective study centre. Results generally showed an acceptable agreement between the LIAISON system and the different methods of comparison. The reference ranges for all assays were found to be in accordance with data known from the literature. All assays showed similar results for serum, heparinised plasma and EDTA plasma. Additionally, two experiments were performed with only one of the analytes tested: the sample-to-sample carry-over, using the CA 19-9 assay (3.3 x 10(-6)-2.3 x 10(-5)) and the functional sensitivity for the PSA assay (0.2 ng/ml).     

Evaluation of the automated haematology analyser Sysmex M-2000

The automated Sysmex M-2000 was evaluated according to the ICSH (International Committee for Standardization in Haematology) protocol. After dilution of packed cells with cell-free plasma, blood cell counts were linear. The overall precision of the measured parameters was good; the CV's ranged between 0.64% and 2.06%. The carry-over was negligible; platelets showed the biggest carry-over with 0.25% in the Whole Blood Mode, while red blood cells (RBC) showed a carry-over of 0.55% in the Prediluted Mode. 300 clinical samples were measured on the Sysmex M-2000 and the Sysmex CC-700 with PL-100, and the results were compared. The coefficients of correlation for white blood cells (WBC), red blood cells (RBC), haemoglobin and haematocrit were greater than 0.99; platelets showed an r of 0.982. Comparison of the results from the Sysmex M-2000 trimodal leukocyte distribution with a manual 100 cell differentiation showed a close correlation for lymphocytes (r = 0.948), and neutrophils (r = 0.931). The middle cell fraction corresponding to monocytes, eosinophils and basophils showed a correlation with r = 0.703. Pathological samples showed no interference with the blood count. Leukocyte counts less than 1000 x 10(9)/l did not effect the measurement of haemoglobin. During the period of evaluation, no instrument malfunctions occurred. Because of its precision and reliability, the Sysmex M-2000 is well suited for routine work and stat analysis in medium-sized laboratories.     

Evaluation of the automated haematology analyser Sysmex NE-8000

The automated haematology analyser Sysmex NE-8000 was compared with the Technicon H-1, the automated analyser routinely used in our laboratory, and with manual cell differentiation results. One hundred and seventy samples from the daily routine workload, comprising specimens from healthy adults and patients with various ailments, were analysed on the Sysmex NE-8000 and the Technicon H-1. A manual-400 leukocyte differential count was performed on each specimen. Comparison of the results from the two blood cell counters showed good correlation (r greater than 0.9) for the white blood cell count, haemoglobin, haematocrit and platelet count. For the red blood cell count and mean cellular volume, the correlation coefficients were greater than 0.8. In the leukocyte differential count, Sysmex NE-8000 and Technicon H-1 showed good correlations for the neutrophil (r = 0.953), lymphocyte (r = 0.763), and eosinophil counts (r = 0.904). Correlation coefficients were very low for monocyte (r = 0.130) and basophil counts (r = 0.006). Correlation between the manual-400 method and the electronic leukocyte differential count showed similar results. Two hundred and twenty six normal and abnormal samples were compared with respect to morphology flagging with the two analysers, using the manual differentiation as the reference method. The abnormal specimens were representative of the range of leukocyte abnormalities seen in our laboratory. Sensitivity for detecting blasts was equal for both analysers. Sysmex NE-8000 was much more sensitive for detecting immature granulocytes than Technicon H-1. Low ranges of atypical lymphocytes were missed by Sysmex NE-8000. Left shift was also frequently missed.(ABSTRACT TRUNCATED AT 250 WORDS)     

FUS-100全自动尿沉渣分析仪临床应用性能评价

目的评价FUS-100全自动尿沉渣分析仪（简称FUS-100）检测尿液有形成分的性能。方法随机留取尿液标本,对FUS-100的精密度、线性、携带污染率、稳定性、可比性、准确性等性能进行检测评价。结果高、中、低值标本批内精密度红细胞（RBC）分别为3.80%、4.78%、18.54%,白细胞（WBC）分别为3.35%、3.85%、11.05%,上皮细胞（EC）分别为6.41%、10.87%、19.05%。RBC和WBC的线性相关系数分别为0.999、0.993。RBC、WBC、EC检测携带污染率分别为0.49%、0.74%、0.98%,2 h内测定稳定性（CV）分别为7.45%、5.50%、8.75%。FUS-100检测与人工显微镜检计数比较：RBC、WBC、EC的相关性分别为0.983、0.976、0.962;阴性过筛准确率为100%;FUS-100识别RBC、WBC、EC的准确率分别为96%、94%、90.1%。结论 FUS-100的综合性能可靠,且自动化的程度较高、检测速度快、样本无需离心、报告结果规范,具有很高的临床应用价值。     

流式尿沉渣分析仪、尿干化学分析仪检测尿红、白细胞的分析研究

目的探讨流式尿沉渣定量分析仪、尿干化学分析仪及尿沉渣定量计数在尿液常规分析中的临床应用价值。方法随机选取我院521例住院患者晨尿标本,分别用AX-4280尿干化学分析仪、IQ-200尿沉渣定量分析仪及Dia Sys沉渣定量系统进行检测,分析多个参数结果。结果(1)三种方法对尿液中红、白细胞的检出率较一致。(2)三种方法对红细胞检测敏感度略高于白细胞的敏感度。(3)流式尿沉渣定量分析与干化学法结合能大大提高对红细胞、白细胞检测的敏感度。结论流式尿沉渣定量分析与干化学分析仪敏感度较高,两者联合应用具有较高的准确性和敏感度,能提高工作效率。     

流式尿沉渣分析仪、尿干化学分析仪检测尿红、白细胞的分析研究

目的探讨流式尿沉渣定量分析仪、尿干化学分析仪及尿沉渣定量计数在尿液常规分析中的临床应用价值.方法随机选取我院521例住院患者晨尿标本,分别用AX-4280尿干化学分析仪、IQ-200尿沉渣定量分析仪及Dia Sys沉渣定量系统进行检测,分析多个参数结果.结果 （1）三种方法对尿液中红、白细胞的检出率较一致.（2）三种方法对红细胞检测敏感度略高于白细胞的敏感度.（3）流式尿沉渣定量分析与干化学法结合能大大提高对红细胞、白细胞检测的敏感度.结论流式尿沉渣定量分析与干化学分析仪敏感度较高,两者联合应用具有较高的准确性和敏感度,能提高工作效率.     

An evaluation of the Gilford 3400 automatic enzyme analyser.

An assessment of the Gilford Automatic Enzyme Analyser was conducted over a period of one year. The optics of the instrument were satisfactory with regard to accuracy of wavelength selection and linearity of absorbance response. Excellent precision was obtained for both absorbance readings and operation of the dispenser pump. Carry-over within the microflow-cell was low. The method of operation recommended by the manufacturers for enzyme determinations failed to take account of endogenous blank reactions which could lead to significant error. When revised methods utilising a pre-incubation stage and initiation with a single substrate were employed, the results correlated well with those obtained with standard automatic (LKB 8600) and manual (Pye Unicam SP 800) kinetic systems for aspartate and alanine aminotransferase, creatine phosphokinase and alpha-hydroxybutyrate dehydrogenase, and the precision at all activity levels was satisfactory. Acceptable precision could not be obtained over the clinical range for enzyme assays requiring a blank determination on each sample (5'-nucleotidase and adenosine deaminase) and those with very low normal serum activities (isocitrate dehydrogenase and glutamate dehydrogenase). These limitations appeared to be due to relative insensitivity of the transducer response and liability to optical disturbance. This apart, the instrument has many advantages over alternative equipment.     

An evaluation of the Olympus "Quickrate" analyser.

The Olympus "Quickrate", a photometer built for both kinetic and end point analysis was evaluated in this laboratory. Aspartate transaminase, lactate dehydrogenase, hydroxybutyrate dehydrogenase, creatine kinase, alkaline phosphatase and gamma glutamyl transpeptidase were measured in the kinetic mode and glucose, urea, total protein, albumin, bilirubin, calcium and iron in the end point mode. Overall, good correlation was observed with routine methodologies and the precision of the methods was acceptable. An electrical evaluation was also performed. In our hands, the instrument proved to be simple to use and gave no trouble. It should prove useful for paediatric and emergency work, and as a back up for other analysers.     

IQ200全自动尿沉渣分析仪在筛查尿路感染中的意义

目的 探讨iQ200全自动尿沉渣分析仪在尿路感染中的筛选意义.方法 以50例健康体检者为对照,收集240例怀疑尿路感染的门诊患者的两份尿液标本.一份用IQ200尿沉渣分析仪检测细菌（BACT）,根据检测结果分为BACT阳性组与BACT阴性组来进行细菌培养,以细菌培养结果作为标准,比较iQ200对尿路感染的筛查意义.结果 BACT阳性组的细菌培养结果阳性率最高,iQ200对革兰氏阴性菌与革兰氏阳性菌与真菌的诊断效能：灵敏度为96.6%、86.6%、94.5%,特异度为94.4%、58.1%、87.6%,准确度为95.0%、61.6%、88.7,iQ200对革兰氏阴性菌与真菌有较佳的筛选价值,对革兰氏阳性菌的特异性较低.结论 IQ200尿沉渣分析仅对尿路感染具有一定的筛选作用,但不能完全代替细菌培养.