LightCycler 480Ⅱ型实时荧光定量PCR仪性能评价

目的对Roche LightCycler 480Ⅱ型实时荧光定量PCR仪(Roche 480)主要性能指标进行评价,为该仪器检测结果的可靠性提供依据。方法按照美国临床实验室标准化委员会(CLSI)文件制定的评价标准,分别对40例标准血清和40例临床标本定量检测HBV-DNA,评价其精密度、准确度、灵敏度、线性和可比性。结果精密度:批内变异系数(CV批内)为1.40%～2.10%,批间变异系数(CV批间)1.17%～1.40%,总变异系数(CV)为1.40%～1.83%;准确度:与标准品比较,相对偏差为0.35%～0.41%;灵敏度:对血清HBV-DNA浓度大于或等于4×103IU/mL的标本检出率为100%,对血清HBV-DNA浓度为4×102IU/mL的标本检出率为90%;线性:相关系数为0.999,直线回归方程为Y=1.0073X-0.0487;Roche480和Roche Light-Cycler1.2(Roche1.2)2台PCR仪的可比性:P=0.113,相关系数为0.995,线性比对直线回归方程为Y=0.9230X+0.3397。结论 Roche 480具有良好的精密度、准确度、灵敏度、线性,与Roche1.2检测系统有良好的相关性,能够满足临床需要。     

ABI 7300实时荧光定量PCR仪的性能评估

目的为参加医学实验室认可和评价仪器性能,对ABI 7300实时荧光定量PCR仪的性能进行评估。方法参照美国临床实验室标准化委员会(CLSI)文件对ABI 7300荧光定量PCR仪检测HBV-DNA定量结果的精密度、正确度、灵敏度及线性进行评价。结果精密度:批内变异系数(CV批内)为2.38%~4.61%,批间变异系数(CV批间)为3.87%~5.33%,达到《医学实验室质量和能力认可准则》中基因扩增检验项目分析性能标准(CV批内4.8%,CV批间6.4%)。正确度:参加2011年卫生部室间质评结果总体平均偏倚为2.14%,符合卫生部质评要求(偏倚不超过8%);功能灵敏度:100IU/mL检测限浓度的CV值最接近于20%,与试剂盒检出下限相符;线性:相关系数(r2)为1.0,线性关系符合要求。结论 ABI 7300实时荧光定量PCR仪各项性能指标精确,可以为临床提供快速、准确的报告。     

ABI7700、7500荧光定量PCR仪性能评价

目的 对美国ABI 7700、7500荧光定量PCR仪的主要性能指标进行评价.方法 按照美国临床实验室标准化委员会(NCCLS)制定的评价标准,对20份标本(HBV-DNA)定量检测,评价两种仪器的精密度、准确性、线性、可比性、灵敏度等指标.结果 精密度:ABI 7700批内变异系数(CV)为3.67%～5.58%,批问为4.46%～6.53%;7500批内CV为4.09%～5.61%,批间为4.73%～6.96%.准确性:与标准质控物比较,相对偏差7700为0.93%,7500为2.97%.线性:ABI 7700 r=0.999,7500 r=0.995.灵敏度:ABI 7700、7500能检测到的最低HBV-DNA浓度均为1000 U/ml.两种仪器的可比性:相关系数为0.994,直线回归方程为.y=1.0694x-0.1372.结论 两种荧光定量PCR仪各种指标性能均良好.     

实时荧光定量PCR与PCR-ELISA在乙型肝炎病毒DNA定量检测中的应用比较

目的评价应用国产试剂的实时荧光定量聚合酶链反应(PCR)在检测乙型肝炎病毒(HBV)DNA中的临床应用。方法基于TaqMan探针技术的实时荧光定量PCR应用Roche公司LightCycler仪器和国产达安试剂,PCR酶联免疫吸附试验(ELISA)应用Roche公司COBASAmplicor全自动内标法系统,用2种方法检测乙型肝炎患者血清中的HBVDNA,评价其灵敏度、精密度及相关性。结果实时荧光定量PCR方法的灵敏度略低于PCR ELISA全自动内标法,两者变异系数(CV)均较低,用2种方法检测临床标本,相关系数为0.890。结论应用国产试剂配合LightCycler仪器的实时荧光定量PCR具有较高的灵敏度和较好的重复性,并与PCR ELISA全自动内标法有良好的相关性。     

ABI ViiA 7 Taqman HBV-DNA检测系统性能验证

目的验证ABI ViiA 7Taqman HBV-DNA检测系统性能,确定该系统是否稳定、准确、可靠。方法参考美国临床实验室标准化协会(CLSI)颁布的相关文件,从精密度、准确度、线性、可比性等方面对ABI ViiA 7Taqman HBV-DNA检测系统进行性能评价;通过稀释标本直至低于检测下限进行定量检出限验证实验;并与质量目标要求和厂商声明的分析性能进行比较。结果ABI ViiA 7Taqman HBV-DNA分析系统的批内精密度(CV批内)分别为1.485%、1.990%和0.932%;总精密度(CV总)分别为1.876%、3.361%和1.891%;准确度最大偏移为-6.8%;r2为0.998 3,回归方程为Y=0.974 8 X+0.050 7,线性范围为1.00E2~2.00E8;定量检出限为100IU/mL;ABIViiA7与ABI7500两台PCR仪的可比性:P=0.115,r2=0.994,线性比对直线回归方程为Y=0.987 2 X+0.051 7。结论 ABI ViiA 7Taqman HBV-DNA检测系统具有优良的精密度、准确度、灵敏度、线性,与ABI7500检测系统有良好的相关性,可用于临床标本检测。     

iQ~(TM) 200全自动尿沉渣定量分析仪的临床应用与评价

目的评价iQTM200全自动尿沉渣定量分析仪的性能及临床应用价值。方法我们对仪器的精密度、携带污染率、线性等指标进行了评价,并随机选择370例患者尿标本,分别用iQTM200全自动尿沉渣定量分析仪及手工定量尿沉渣镜检法对红细胞、白细胞进行比对分析。结果仪器的批间精密度分高值、中值、低值3个水平进行测定,分别为7.1%、2.8%、7.3%;批内精密度红细胞变异系数(CV)为5.5%、白细胞CV为4.0%;红细胞、白细胞携带污染率分别为0%～1.23%、0.13%～1.08%;线性评价:红细胞、白细胞在0～2000μl内相关系数分别为0.997、0.999。iQTM200全自动尿沉渣定量分析仪与手工定量尿沉渣镜检法相对灵敏度分别为89.5%、84.6%。结论iQTM200全自动尿沉渣定量分析仪可用于临床进行尿沉渣的定量分析,以替代繁琐的手工定量尿沉渣镜检。     

荧光定量PCR仪检测乙型肝炎病毒核酸的性能验证及评价

目的荧光定量聚合酶链反应(PCR)仪检测乙型肝炎病毒核酸(HBV DNA)的性能验证及评价。方法参考ISO15189《医学实验室质量和能力认可准则(2012年)》,以及美国临床和实验室标准化协会(CLSL)EP系列文件的相关要求对实验室HBV DNA荧光定量PCR检测系统的精密度、正确度、可报告范围、抗干扰能力进行验证及评价。结果精密度:HBV DNA定量检测高浓度(106 IU/mL)和低浓度(103 IU/mL)标本的对数值批内变异系数分别为0.67%和3.65%,批间变异系数分别为1.72%和4.52%;正确度:标准物质标本检测结果的对数值与厂商给定靶值浓度的对数值差值在±0.4个Log值内;可报告范围:试验试剂在(2.22×10)～(2.22×108)IU/mL范围内具有良好的线性,线性回归方程为Y=1.027 X-0.408,R2=0.995,≥0.95;抗干扰能力:说明书浓度的干扰物质(血红蛋白、三酰甘油、胆红素)标本结果与不含干扰物质标本比较,其浓度的对数值偏倚CV7.5%,对数值差值在±0.4个Log值内。结论荧光定量PCR仪检测HBV DNA试剂的各项性能特征与厂家声明相符,满足预期用途,适用于临床常规检测。     

一种乙型肝炎病毒核酸PCR定量检测试剂的性能验证

目的验证和评价一种乙型肝炎病毒核酸(HBV DNA)定量PCR检测试剂的性能。方法根据美国临床和实验室标准化协会(CLSI)EP系列文件和ISO15189:2012的相关要求对试验试剂的精密度、正确度、可报告范围、定量检测限进行评价。结果精密度:高值(106 IU/mL)、低值(103 IU/mL)标本检测浓度对数值的批内变异系数(CV)分别为3.27%、4.00%,批间CV分别为4.84%、4.89%;正确度:试验试剂与比对试剂具有较好的相关性,直线回归方程为Y=1.006 2 X+0.226 4,r2=0.984 70.95;可报告范围:试验试剂在4.76×102~4.76×108 IU/mL范围内具有良好的线性(Y=0.995 9 X+0.183 9,r2=0.9990.95);定量检测限为500IU/mL。结论试验试剂的各项检测性能与厂家声明相符。     

IMS-972电解质分析仪性能评价

目的对IMS-972电解质分析仪性能进行评价。方法通过分析钾离子(K~+)、钠离子(Na~+)、氯离子(Cl-)的检测精密度、准确度、线性范围及参考区间等对IMS-972电解质分析仪性能进行评价。结果 IMS-972电解质分析仪检测K~+正常水平与病理水平的批内精密度变异系数(CV)分别为0.38%和0.66%,批间精密度CV分别为0.39%和0.95%;Na~+正常水平与病理水平的批内精密度CV分别为0.14%和0.22%,批间精密度CV分别0.31%和0.45%;Cl-正常水平与病理水平的批内精密度CV分别为0.60%和0.93%,批间精密度CV分别为0.51%和1.54%,均满足美国《临床实验室改进法案修正案》(CLIA′88)标准。准确度检测结果在室间质评的允许范围。线性:K~+Y=0.989 7 X~+0.490 0,R~2=0.997 4;Na~+Y=0.996 7 X-1.584 8,R~2=0.999 2;Cl-Y=0.996 9 X~+0.294 3,R2=1.000 0。可报告范围:K~+1.97~20.44mmol/L,Na~+28.80~195.95mmol/L,Cl-13.20~164.54mmol/L。生物参考区间验证通过。结论验证方案可操作性和实用性强,IMS-972电解质分析仪检测电解质项目在精密度、准确度、线性范围等方面均达到了生物化学检验实验室的要求,可用于临床标本检测。     

SLAN-96P型荧光定量PCR仪性能评价及其应用

目的评价SLAN-96P型荧光定量PCR仪(SLAN-96P)的主要性能指标及其应用价值。方法按照美国临床实验室标准化协会(CLSI)文件制定的评价标准,对40份临床血清标本、质控品和标准品进行乙型肝炎病毒DNA(HBV-DNA)定量检测,评价该仪器的准确性、重复性、线性、灵敏度、A模块与B模块的可比性等指标。结果准确度的相对偏倚为0.2%~5.2%;重复性:批内变异系数(CV_(批内))为1.37%~2.75%,批间变异系数(CV_(批间))为1.52%~2.51%;灵敏度:SLAN-96P能检测的最低HBV-DNA浓度为10~2 IU/mL;线性:直线回归方程是Y=0.982 X+0.094 8,相关系数(r)=0.999;A模块与B模块的可比性:A模块与B模块的检测结果差异无统计学意义(P0.05),直线回归方程为Y=1.000 7 X+0.012 4,r=0.994。结论 SLAN-96P型荧光定量PCR仪各项性能指标良好,SLAN-96P在病原微生物核酸检测方面具有高效、灵敏、快捷、定量的特点,具有很好的临床应用价值。     

Determination of creatine kinase isoenzyme MB activity in serum using immunological inhibition of creatine kinase M subunit activity. Activity kinetics and diagnostic significance in myocardial infarction.

This is a new method for the determination of creatine kinase isoenzyme MB activity in serum. The method uses direct activity measurement of creatine kinase B subunit activity after blocking of CK-M subunit activity by inhibiting antibodies. The test takes no longer than 15 min. The method yields an intra-serial C.V. of 2.0-12.9%, and a C.V. from day to day of 5.5%. The detection limit is 3.4 U/l creatine kinase MB. In the 95 cases with proven myocardial infarction several types of creatine kinase MB activity kinetics could be determined. The percentage of creatine kinase MB of peak CK-total is 6-25%, with a mean of 11.1%. The amount of creatine kinase MB with respect to total CK activity after reinfarction is higher than the amount after initial infarction.     

俯卧位通气对高海拔地区肺复张治疗无效急性呼吸窘迫综合征患者氧合的影响

目的 探讨俯卧位通气对高海拔地区肺复张术(RM)治疗无效急性呼吸窘迫综合征(ARDS)患者的治疗作用.方法 从海拔2260m的地区医院筛选RM治疗无效的41例ARDS患者[平均氧合指数( PaO2/FiO2)较RM前升高＜20％视为RM无效],依不同病因分为肺内源性ARDS组(ARDSp组)和肺外源性ARDS组(ARDSexp组),每组再按信封法随机分为俯卧位组和仰卧位组,即ARDSp俯卧位组(11例)、ARDSp仰卧位组(9例)、ARDSexp俯卧位组(10例)、ARDSexp仰卧位组(11例).在通气前及通气1、2、3、4h监测动脉血氧分压( PaO2)、PaO2/FiO2、静态顺应性(Cst)、气道阻力(Raw)的变化.结果 通气lh时,ARDSexp俯卧位组PaO2/FiO2( mm Hg,l mm Hg=0.133 kPa)即较通气前显著升高(157.4±40.6比129.3±48.7,P＜0.05),并随通气时间延长呈持续增高趋势,4h达峰值(219.1 ±41.1);且ARDSexp俯卧位组通气3h内PaO2/FiO2较其他3组显著增高,另3组间则差异无统计学意义.ARDSp俯卧位组、ARDSexp俯卧位组通气4h时PaO2/FiO2均较相应仰卧位组显著增高(208.8±39.7比127.4±47.1,219.1±41.1比124.9±50.8,均P＜0.05).4组通气前后Cst无显著改变,各组间差异也无统计学意义.ARDSp俯卧位组通气4h时Raw(cmH2O·L-1·s-1)较通气前显著降低(6.8±1.7比10.7±1.8,P＜0.05),且明显低于其他3组;其他3组各时间点Raw组内及组间比较差异均无统计学意义.结论 俯卧位通气作为ARDS机械通气重要策略之一,可以改善RM无效高原ARDS患者的氧合,为抢救患者赢得宝贵的时间.     

Digital imaging among medical facilities

The Department of Veterans Affairs (VA) in the USA operates a network of 172 medical centres which all utilize a hospital information system (HIS) which has been developed and is currently maintained by the VA. During the past several years, an image management and communication module has been developed, installed and clinically utilized at the Washington DC and Maryland VA Medical Centres. This image management and communication system, referred to as the decentralized hospital computer program (DHCP) imaging system, is fully integrated with a commercial picture archiving and communication system (PACS). The system is utilized to capture, archive, and display all images generated within the hospital including radiology, nuclear medicine, pathology, endoscopy, bronchoscopy, and dermatology, intraoperative photographs, ECG data, and a limited number of paper documents. The ultimate goal of the project is to have all patient text and image data available at any clinical workstation to any authorized user anywhere within the network of medical centres. Clinical requirements for an imaging workstation include ease of use, rapid and reliable access to the complete set of patient information, and images which are of acceptable quality to meet the requirements of the user and the subspecialty. Patient confidentiality and data security must be safeguarded at all times. Integration of the images with the remainder of the patient's database was found to be critical to the success of the project. The experience at the Washington and Maryland facilities suggests that an imaging system that is successfully integrated with a hospital information system can provide substantial clinical and economic benefits both within and among medical centres. Clinical acceptance and utilization of the system has been excellent, particularly in diagnostic radiology where DHCP Imaging has been interfaced to a commercial PAC system. Based upon this initial experience, the VA has begun to deploy the system throughout its large network of medical centres.     

Myocardial elastography at both high temporal and spatial resolution for the detection of infarcts

Myocardial elastography is a novel method for noninvasively assessing regional myocardial function, with the advantages of high spatial and temporal resolution and high signal-to-noise ratio (SNR). In this paper, in-vivo experiments were performed in anesthetized normal and infarcted mice (one day after left anterior descending coronary artery [LAD] ligation) using a high-resolution (30 MHz) ultrasound system (Vevo 770, VisualSonics Inc., Toronto, ON, Canada). Radiofrequency (RF) signals of the left ventricle (LV) in longitudinal (long-axis) view and the associated electrocardiogram (ECG) were simultaneously acquired. Using a retrospective ECG gating technique, 2-D full field-of-view RF frames were acquired at an extremely high frame rate (8 kHz) that resulted in high-quality incremental displacement and strain estimation of the myocardium. The incremental results were further accumulated to obtain the cumulative displacements and strains. Two-dimensional and M-mode displacement images and strain images (elastograms), as well as displacement and strain profiles as a function of time, were compared between normal and infarcted mice. Incremental results clearly depicted cardiac events including LV contraction, LV relaxation and isovolumetric phases in both normal and infarcted mice, and also evidently indicated reduced motion and deformation in the infarcted myocardium. The elastograms indicated that the infarcted regions underwent thinning during systole rather than thickening, as in the normal case. The cumulative elastograms were found to have higher elastographic SNR (SNR(e)) than the incremental elastograms (e.g., 10.6 vs. 4.7 in a normal myocardium, and 6.0 vs. 2.4 in an infarcted myocardium). Finally, preliminary statistical results from nine normal (m = 9) and seven infarcted (n = 7) mice indicated the capability of the cumulative strain in differentiating infracted from normal myocardia. In conclusion, myocardial elastography could provide regional strain information at simultaneously high temporal (>/=0.125 ms) and spatial ( approximately 55 microm) resolution as well as high precision ( approximately 0.05 microm displacement). This technique was thus capable of accurately characterizing normal myocardial function throughout an entire cardiac cycle, at the same high resolution, and detecting and localizing myocardial infarction in vivo.     

手转胎头术失败的原因与分娩结局临床分析

目的 探讨手转胎头术失败的原因与分娩结局.方法 选择2008年1月至2010年12月于我院住院分娩的持续性枕横位、枕后位产妇198例,根据行手转胎头术后结果分为成功组126例、失败组72例.比较两组分娩结局,对比分析失败原因.结果 失败组胎儿体质量≥3500 g的发生率[76.4％(55/72)]明显高于成功组[31.7％(40/126)],差异有统计学意义(x2=30.177,P=0.001)、失败组宫缩乏力发生率[58.3％(42/72)]高于成功组[38.1％ (48/126)],差异有统计学意义(x2=7.569,P=0.006)、失败组骨盆临界或轻度狭窄发生率[38.9％ (28/72)]高于成功组[23.8％(30/126)],差异有统计学意义(x2 =5.030,P=0.002)、失败组手转胎头时机不当(宫口开大＜6 cm、胎头位于坐骨棘上及宫口开大8～10 cm、胎头位于坐骨棘下≥2 cm)发生率[61.1％(44/72)]高于成功组[38.9％(49/126)],差异有统计学意义(x2=9.084,P=0.003).失败组母儿并发症(产后出血、产褥病率、胎儿窘迫、新生儿窒息)发生率高于成功组(x2 =9.586,P=0.002、x2=9.334,P=0.002、x2=5.910,P=0.015、x2=5.240,P=0.022)、失败组剖宫产发生率[72.2％(52/72)]明显高于成功组[34.1 ％(43/126),x2=26.641,P=0.001)].结论 手转胎头术能使难产变顺产,降低剖宫产率,减少母儿并发症,但须积极预防、处理导致手转胎头术失败的原因,对矫正失败后继续矫正及试产应慎重.     

Clinical Pharmacokinetics of Morphine

Morphine, the most widely used mu-opioid analgesic for acute and chronic pain, is the standard against which new analgesics are measured. A thorough understanding of the pharmacokinetics of morphine is required in order to safely and effectively use this analgesic in a wide variety of patients with different levels of organ function. A MEDLINE search was conducted to identify literature published between 1966 and January 2002 relevant to the pharmacokinetics of morphine. These publications were reviewed and the literature summarized regarding unique and clinically important elements of morphine disposition relative to its parenteral administration (including intravenous, intramuscular, subcutaneous, epidural and intrathecal administration), absorption profile (immediate release, controlled release, and sublingual/buccal, and rectal administration), distribution, and its metabolism/ excretion. Special populations, including infants, elderly, and those with renal/liver failure, have a unique morphine pharmacokinetic profile that must be taken into account in order to maximize analgesic efficacy and reduce the risk of adverse events.     

Evidence-Based Pain Management and Palliative Care in Issue Four for 2009 of The Cochrane Library

ABSTRACT

The Cochrane Library of Systematic Reviews is published quarterly. Issue 4 for 2009 contains 4027 complete reviews, 1906 protocols for reviews in production, and 11447 one-page summaries of systematic reviews published in the general medical literature. In addition, there are citations of 600,000 randomized controlled trials, and 12,200 cited papers in the Cochrane methodology register. The health technology assessment database contains over 7500 citations. This edition of the Library contains 90 new reviews, of which 19 have potential relevance for practitioners in pain and palliative medicine.     

Wie zuverlässig sind Angaben zu nichtentzündlichen ausgedehnten Schmerzen?

ZusammenfassungFragestellung Es wurde geprüft, wie sich der Differenziertheitsgrad zweier Schmerzmessmethoden auf Angaben zur Ausgedehntheit klinischer Schmerzen auswirkt. Zugleich wurde der Referenzzeitraum variiert, über den die Patienten berichten sollten.Methode Erfasst wurde der Einfluss zu Lasten der Befragungsdifferenziertheit durch den Vergleich zweier Körperschema-Bildvorlagen. Drei Referenzzeiträume (Schmerz aktuell, letzte Woche, letztes halbes Jahr) wurden vorgegeben.Ergebnisse Patienten mit ausgedehnten Schmerzen gaben bei differenzierter Befragung um so mehr Schmerzen an, je weiter die Schmerzen zurück lagen und je größer der Berichtszeitraum war. Patienten mit gelenknahen Schmerzen gaben bei hoch differenzierter Befragung weniger ausgedehnte Schmerzen in der Vergangenheit an als bei globaler Einschätzung. Patienten mit Rückenschmerzen berichteten bei differenzierter Befragung zum aktuellen Schmerz über weniger ausgedehnte Schmerzen als bei globaler Befragung.Schlussfolgerung Die Angaben zur Schmerzausdehnung variieren vor allem bei Patienten mit ausgedehnten Schmerzen in Abhängigkeit von der Differenziertheit der Befragung. In diesen Fällen ist die Wahrscheinlichkeit erhöht, dass sich die Beschwerdesymptomatik zumindest teilweise erst in der Reaktion auf die situativen Befragungsbedingungen konstituiert und daher nicht auf andere Befragungsbedingungen generalisiert werden kann.