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检验医学与临床 2010年第13期7卷 1355-1357页

作者：林峭影浙江省温岭市中医院检验科 317500

目的通过对泌乳素(PRL)在不同检测系统的测定结果进行方法比对和偏倚评估,探讨不同检测系统间PRL测定结果是否具有可比性或检测结果偏倚是否在允许范围内,以确保不同免疫分析系统检测结果的准确性和一致性。方法按照美国临床实验室标准... 详细信息

目的通过对泌乳素(PRL)在不同检测系统的测定结果进行方法比对和偏倚评估,探讨不同检测系统间PRL测定结果是否具有可比性或检测结果偏倚是否在允许范围内,以确保不同免疫分析系统检测结果的准确性和一致性。方法按照美国临床实验室标准化委员会(NCCLS)EP9-A文件的要求,取雅培不同水平的质控物以及30例患者不同浓度的新鲜血清,用美国雅培I2000SR分析仪和雅培AXSYM免疫检测系统及其配套的校准物和试剂进行PRL检测,以澳大利亚室间质量评价标准为标准,对两个分析系统间的偏倚进行评估。结果两个检测系统间不同水平的质控物和不同浓度的患者新鲜血清PRL测定结果差异无统计学意义(P>0.05),PRL测定结果的信度系数均接近1;偏倚在方法线性范围内均可以接受。结论雅培I2000SR分析仪和雅培AXSYM免疫检测系统具有很好的相关性,两个免疫测定系统所测PRL结果具有可比性。当同一实验室同一检验项目存在两个以上的检测系统时,应进行方法比对和偏差评估,以保证检验结果的可比性。

关键词：泌乳素免疫测定/仪器和设备偏倚评估

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美国雅培AxSYM化学发光分析仪性能评价

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检验医学与临床 2008年第9期5卷 558-559页

作者：曹娟徐加勤浙江省台州医院路桥院区检验科 318050

目的对美国雅培公司生产的AxSYM化学发光分析仪的性能进行评价。方法对该仪器批内精密度、批间精密度、污染率试验及对比试验进行测定分析。结果该仪器批内精密度低于仪器精密度、交叉污染率小于1%,与美国贝克曼-库尔特公司生产的Acces... 详细信息

目的对美国雅培公司生产的AxSYM化学发光分析仪的性能进行评价。方法对该仪器批内精密度、批间精密度、污染率试验及对比试验进行测定分析。结果该仪器批内精密度低于仪器精密度、交叉污染率小于1%,与美国贝克曼-库尔特公司生产的Access对比试验相关性超过0.940。结论雅培AxSYM化学发光分析仪具有良好检测性能,符合一般实验室要求。

关键词：免疫测定/仪器和设备实验室技术和方法评价研究

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全自动电化学发光免疫分析仪残量试剂再利用可行性探讨

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医学临床研究 2005年第10期22卷 1444-1445页

作者：邹珊静湖南省妇幼保健院湖南长沙410008

【目的】探讨Roche Elecsys 2010全自动电化学发光免疫分析仪残量试剂再利用的可行性及意义。【方法】回收残量试剂进行重复性检测及质控检测,并与新试剂检测同一组标本AFP、CA125含量及两组均数比较。【结果】回收残量试剂检测AFP质控... 详细信息

【目的】探讨Roche Elecsys 2010全自动电化学发光免疫分析仪残量试剂再利用的可行性及意义。【方法】回收残量试剂进行重复性检测及质控检测,并与新试剂检测同一组标本AFP、CA125含量及两组均数比较。【结果】回收残量试剂检测AFP质控血清低中高浓度变异系数批内分别为2.5%、6.70%、1.74%;批间分别为1.82%、5.60%、1.98%。检测CA125质控血清低中高浓度变异系数批内分别为2.70%、1.23%、2.48%;批间分别为2.32%、3.40%、1.77%。重复性符合要求;质控检测结果在允许范围内;回收残量试剂与新试剂检测同一组标本AFP、CA125含量结果差异无显著性(P>0.05),两项目两组结果(r>0.95),有良好相关性。【结论】Roche Elecsys2010免疫分析仪残量试剂回收率平均值接近100%,且性能稳定、质量可靠,在保证检验质量的前提下达到降低检测成本目的。

关键词：免疫测定/仪器和设备

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A three-dimensional numerical fluid dynamic model of antigen-antibody surface adsorption on piezoelectric immunosensors

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ANNALS OF BIOMEDICAL ENGINEERING 2002年第10期30卷 1313-1322页

作者： Barak-Shinar, D Rosenfeld, M Zisman, E Abboud, S Tel Aviv Univ Fac Engn Dept Biomed Engn IL-69978 Tel Aviv Israel Tel Aviv Univ Fac Engn Dept Fluid Mech & Heat Transfer IL-69978 Tel Aviv Israel Savyon Diagnost Ltd Ashdod Israel

A piezoelectric crystal is a unit that changes its frequency in parallel with a change in its mass. This characteristic is exploited in designing flow cell-based immunosensors for detecting the concentration of antibodies in liquid samples. In the present study, computational fluid dynamic techniques are used to optimize the antigen-antibody binding process on an electrode surface placed on the base of a conical flow cell. The geometry optimization of the flow cell was determined to minimize the test time. This time is needed for the electrode to be saturated by the antibody, a process that requires the maximization of the adsorption rate and be accomplished by increasing the shear rate in the vicinity of the electrode. To validate the numerical model and to determine its parameters, experiments were carried out using an identical flow cell. In the experiments, the system did not reach saturation within an acceptable time frame, therefore, the model parameters were determined based on the unsaturated state. The experimental results confirmed the applicability of numerical simulations in predicting the effect of changing the inlet section area of the flow cells, proving the computational model to be very valuable in designing immunosensors based on flow cells. (C) 2002 Biomedical Engineering Society.

关键词：吸附抗体/分析抗体/化学抗体细菌/分析抗体细菌/免疫学抗体单克隆/分析抗体单克隆/免疫学抗原抗体复合物/分析抗原抗体复合物/化学生物传感技术/仪器和设备计算机模拟计算机辅助设计结晶电化学/仪器和设备电化学/方法电极设备设计/方法大肠杆菌/免疫学流式细胞术/仪器和设备流式细胞术/方法免疫测定/仪器和设备免疫测定/方法模型生物学模型化学

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Simultaneous determination of pesticides using a four-band disposable optical capillary immunosensor

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ANALYTICAL CHEMISTRY 2002年第23期74卷 6064-6072页

作者： Mastichiadis, C Kakabakos, SE Christofidis, I Koupparis, MA Willetts, C Misiakos, K Natl Ctr Sci Res Demokritos Inst Radioiostopes & Radiodiagnost Prod Immunoassay Lab GR-15310 Athens Greece Natl Ctr Sci Res Demokritos Inst Microelect GR-15310 Athens Greece Univ Athens Dept Chem Analyt Chem Lab Athens 15771 Greece Syngenta Jealotts Hill Int Res Ctr Bracknell RG42 6EY Berks England

The development of a four-band capillary optical immunosensor for the simultaneous determination of mesotrione, hexaconazole, paraquat, and diquat is described. Four distinct bands (each corresponding to a different analyte) are created in the internal walls of a plastic capillary by immobilizing protein conjugates of the analytes. To perform the assay, the capillary is filled with a mixture of anti-analyte-specific antibodies together with a standard or sample containing the analyte(s). After a short incubation, a mixture of the appropriate second antibodies labeled with fluorescein is introduced into the capillary. To measure the fluorescence intensity bound onto each band, the capillary was scanned, perpendicularly to its axis, by a laser light beam. Part of the emitted photons were trapped into the capillary walls and waveguided to a photomultiplier placed at the one end of the capillary. The analytical characteristics of the assays of mesotrione, paraquat, diquat, and hexaconazole were as follows: detection limits of 0.04, 0.06, 0.09, and 0.10 ng/mL, respectively;dynamic ranges up to 9, 6, 12, and 15 ng/ ml, respectively;intra- and interassay CVs less than 10%. The analytical characteristics of the assays were comparable with those of the corresponding single-analyte fluoroimmunoassays performed in microtitration wells, proving the ability of the proposed immunosensor for reliable multianalyte determinations. Moreover, the combination of low-cost disposable plastic capillary tubes with the low consumption of reagents, the short assay time, and the multianalyte feature of the proposed immunosensor indicates its potential for environmental analysis.

关键词：生物传感技术/仪器和设备生物传感技术/方法生物传感技术/标准环己酮类/分析敌草快/分析一次性设备荧光素荧光染料免疫测定/仪器和设备免疫测定/方法免疫测定/标准百草枯/分析农药/分析敏感性与特异性三唑类/分析

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Comparison of Abbott AxSYM, Behring Opus Plus, DPC immulite and ortho-clinical diagnostics vitros ECi for measurement of cardiac troponin I

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ANNALS OF CLINICAL BIOCHEMISTRY 2001年第2期38卷 140-146页

作者： Kao, JT Wong, IL Lee, JY Chen, RC Natl Taiwan Univ Hosp Dept Lab Med Taipei Taiwan Natl Taiwan Univ Coll Med Sch Med Technol Taipei Taiwan

Myocardial infarction is a common cause of morbidity and mortality in patients with chest pain. The presence of human cardiac troponin I (cTnI) in serum is considered to be a highly specific biochemical marker of acute: myocardial infarction. In this study we compare the performances of the Abbott AxSYM, Behring Opus Plus, DPC Immulite and Ortho-Clinical Diagnostics Vitros ECi for the measurement of cTnI. The first two methods use a fluorogenic enzyme-linked immunoassay, whereas the last two use chemiluminescent immunometric assays. All procedures are completely automated. Total percentage coefficients of variation using pooled sera ranged from 5.9 to 6.5% for the AxSYM, 14.4 to 25.6% for the Opus, 6.9 to 9.8% for the Immulite and 4.5 to 5.2% for the Vitros ECi method. The closest correlation between methods, obtained from 120 fresh serum samples, was observed between the Vitros ECi and the Immulite methods, with r=0.99, and the regression line was Immulite cTnI = 1.505 (95% confidence interval 1.474-1.536) x Vitros cTnI-0.154 (-0.702 to 0.394). Receiver operating characteristic curves were nearly identical for all assays, and the areas under the curves were 0.972. 0.927, 0.967 and 0.969 for the AxSYM, Opus, Immulite and Vitros ECi methods, respectively. There was a significant difference between the AxSYM and Opus methods (P= 0.036).

关键词：生物学标记/血液化学发光测定法评价研究荧光染料/诊断应用免疫测定/仪器和设备免疫测定/方法免疫酶技术/仪器和设备免疫酶技术/方法心肌梗死/诊断 ROC曲线敏感性与特异性肌钙蛋白I/血液人类

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Automated immunoassay analysers

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ANNALS OF CLINICAL BIOCHEMISTRY 2001年第3期38卷 217-229页

作者： Wheeler, MJ St Thomas Hosp Dept Chem Pathol London SE1 7EH England

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Development of a fluorescence immunoassay for measurement of paclitaxel in human plasma

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ANALYTICAL BIOCHEMISTRY 2000年第1期283卷 33-38页

作者： Sheikh, SH Abela, BA Mulchandani, A Univ Calif Riverside Dept Chem & Environm Engn Riverside CA 92521 USA

A new fluorescence immunoassay for the quantitative determination of paclitaxel (Pac) under equilibrium conditions was developed. Anti-Pac IgG2a antibody was immobilized through its Pc region to protein A covalently bound to the inside surface of a silanized glass capillary column and the antigen-binding sites of anti-Pac saturated with rhodamine-labeled Pac (Rh-Pac). Analyte Pac was circulated through the column in a closed loop and the steady-state fluorescence of the Rh-Pac displaced from the immobilized antibody was recorded after 6 min. The Ph-Pac fluorescence emission intensity was directly related to the concentration of the Pac analyte over a broad dynamic range of up to 400 ng/ml with a linear range up to 200 ng/ml and lower detection limit of 5.85 ng/ml. While there was no interference from the baccatin III and 10-deacetylbaccatin III, cephalomannine was found to interfere in Pac determination. When applied for measurement of Pac in human plasma, the concentration of Pac determined by the fluorescence assay was found to be in excellent agreement with the Pac added, confirming the potential of the fluorescence immunoassay for clinical application. (C) 2000 Academic Press.

关键词：生物碱类/代谢剂量效应关系药物荧光染料/代谢免疫测定/仪器和设备免疫测定/方法免疫球蛋白G/免疫学紫杉酚/类似物和衍生物紫杉酚/代谢紫杉酚/药代动力学可重复性结果若丹明类/药理学光谱法荧光/仪器和设备光谱法荧光/方法葡萄球菌蛋白质A/代谢紫杉烷类时间因素三萜类/代谢人类

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Detection times and analytical performance of commercial urine opiate immunoassays following heroin administration

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JOURNAL OF ANALYTICAL TOXICOLOGY 2000年第7期24卷 522-529页

作者： Smith, ML Shimomura, ET Summers, J Paul, BD Nichols, D Shippee, R Jenkins, AJ Darwin, WD Cone, EJ Armed Forces Inst Pathol Div Forens Toxicol Off Armed Forces Med Examiner Washington DC 20306 USA Forens Toxicol Drug Testing Lab Ft Meade MD 20755 USA NIDA Intramural Res Program NIH Baltimore MD 21224 USA

The Federal Workplace Drug Testing Program changed urine screening and confirmation cutoff concentrations for opiate testing from 300 to 2000 ng/mL in 1998. Morphine was the designated target compound. An additional heroin metabolite, 6-acetylmorphine (6-AM), was added to the testing procedure with a cutoff concentration 3 10 ng/mL. Testing of 6-AM was required if morphine was positive to assist in medical review. A comparison of the new opiate cutoff concentrations was made with the older cutoff concentration at 300 ng/mL. Six commercial opiate immunoassays, four with a 300-ng/mL cutoff, ONLINE, EMIT, CEDIA and AxSym, and two with 2000-ng/mL cutoffs, ONLINE and EMIT, were selected to test 920 urine samples collected from 11 male human subjects following single doses of heroin. Eight received intravenous doses of 3, 6, and 12 mg heroin HCl and four smoked 3.5-, 5.2-, 10.5-, or 13.9-mg doses of heroin (base). In addition, 183 urine-based blind quality-control specimens were added to the study set to assess linearity, cross-reactivity, and interference. Total morphine, free morphine, and 6-AM were measured in each sample by gas chromatography–mass spectrometry (GC–MS). Linearity, cross-reactivity, and interference results for each immunoassay are described. Detection times, sensitivity, specificity, and efficiency of each assay were determined using data from the specimens collected after heroin administration. Detection times for morphine using the 300-ng/mL cutoff assays was approximately 12 h for low dose and 24 to 48 h for higher doses of heroin. For the two 2000-ng/mL cutoff concentration assays detection time was about 12 h. This was also the detection time for 6-AM by GC–MS. ONLINE had the lowest sensitivity, 60–74%, highest specificity, 98.8–100%, and least interference from a selection of common over-the-counter drugs and opioids. Increasing the cutoff to 2000 ng/mL from 300 ng/mL increased efficiencies of the assays from 72.7 to 82.6% to over 97%.

关键词：投药吸入气相色谱-质谱法海洛因/投药和剂量海洛因/尿免疫测定/仪器和设备注射静脉内吗啡衍生物/尿麻醉品/投药和剂量麻醉品/尿随机分配单盲法物质滥用检测/仪器和设备时间因素人类男(雄)性

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Standardized comparison of processing capacity and efficiency of five new-generation immunoassay analyzers

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CLINICAL CHEMISTRY 2000年第1期46卷 105-111页

作者： Hendriks, HA Kortlandt, W Verweij, WM Stichting Artsen Laboratorium NL-3512 VX Utrecht Netherlands Diakonessenhuis NL-3582 KE Utrecht Netherlands

Background: With the trend toward laboratory and workstation consolidation, more studies are necessary to evaluate instrumentation, solutions for coping with workflow and test diversity, and opportunities for increasing the overall efficiency of laboratory testing. We assessed the processing capacity and efficiency of new-generation immunoassay analyzers by determining productivity parameters of five commercially available systems. Methods: A workload protocol was developed and used to assess processing capacity and efficiency parameters of five immunoassay analyzers under standardized conditions in a real-life routine situation. We studied the ACS:Centaur(R) (analyzer A), Architect(TM) i2000 (analyzer B), Elecsys(R) 2010 tandem (analyzer C), Immulite(R) 2000 (analyzer D), and Vitros ECi (analyzer E) on the basis of a standardized workload protocol that reflected a routine laboratory situation. This workload encompassed reflex and STAT testing, dilutions, and in-run calibration of a new reagent lot number. The analyzers were compared for hands-on labor time, unattended time (UT), throughput, and differentiated relative productivity indexes [RPI(UT);number of reportable results/(processing time - sum of unattended time)]. The RPI data for analyzers linked to an automated taut) sample-handling system [RPI(aut)] were also calculated. Results: The evaluation produced a set of parameters for the productivity of the instruments. An overview of the most important parameters revealed the following: the throughput was 193, 123, 97, 109, and 46 tests/hour for instruments A, B, C, D and E, respectively;the RPI(10) was 425, 238, 161, 445, and 151 tests/operator-hour;the RPI(30) was 229, 136, 118, 264, and 86 tests/operator-hour;the RPI(10,aut) was 1701, 637, 235, 964, and 223 tests/operator-hour;and the RPI(30,aut) was 298, 150, 174, 400, and 114 tests/operator-hour, Conclusions: The combination of a standardized workload protocol and determination of parameters for productivit

关键词：免疫测定/仪器和设备免疫测定/标准试剂盒诊断时间因素人类

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