便携式Celercare M1分析仪与Beckman DxC800分析仪血糖检测的比较分析

目的：对便携式Celercare M1分析仪与Beckman DxC800分析仪血糖检测结果进行比较分析。方法参照美国临床和实验室标准协会(CLSI)EP9-A2方法比较试验方案,收集100例不同血糖浓度患者血清,使用Celercare M1分析仪与Beckman DxC800分析仪测定血糖,比较两种方法血糖测定结果的差异。结果 Celercare M1分析仪血糖中值批内和日间精密度变异系数(CV)分别为1.41%、1.88%,血糖高值批内和日间精密度变异系数(CV)分别为0.78%、0.97%。该分析仪血糖测定结果在1.0mmol/L~30.0mmol/L范围内线性良好,回归方程为y=0.9799x+0.0598(R2=0.999)。 Celercare M1分析仪(y)和Beckman DxC 800(x)血糖测定结果的回归方程为y=0.974x+0.139,R2=0.999(P＜0.001)。在血糖医学决定水平(2.8mmol/L、7.0mmol/L、11.1mmol/L)处的相对偏倚分别为2.4%、0.6%、1.3%,均低于美国临床实验室改进修正法案(CLIA＇88)允许误差范围。结论便携式Celercare M1分析仪血糖测定结果的精密度和线性范围符合临床要求,与Beckman DxC 800分析仪血糖测定结果具有可比性。     

飞测Ⅱ型免疫荧光检测仪检测C-反应蛋白性能验证

目的验证飞测Ⅱ型免疫荧光检测仪检测C-反应蛋白的性能。方法参考美国临床和实验室标准化协会CLSI文件,并结合工作实际情况,以C-反应蛋白作为验证指标,对该仪器精密度、准确度、线性、可比性、稳定性、抗干扰能力进行验证。结果 C-反应蛋白3个浓度水平的批内精密度分别为高值CV4.46%,中值CV3.32%,低值CV6.47%;批间精密度分别为高值CV7.51%,中值CV5.89%,低值CV10.66%,结果均在仪器说明书范围内。准确度验证偏差分别为12.90%和13.95%,均在仪器允许偏差范围内。线性回归方程Y=0.958 X+2.897,相关系数r=0.998,与厂商承诺范围接近。与日本OlympusAU400散射比浊法对比实验检测结果相关性良好,回归方程Y=1.021 X-1.214,r=0.982,两法差异无显著性(P0.05)。稳定性实验表明全血标本在缓冲液中保存30min内结果稳定性良好,CV值2.35%。黄疸和血脂干扰物对测试结果影响较小,平均影响度均5%在可接受范围内。结论飞测Ⅱ型免疫荧光检测仪检测C-反应蛋白的性能符合厂商声明的性能指标。同时该仪器具有操作简单、检测速度快、精密度好、准确度较高、可比性好、抗干扰能力强,临床和患者易接受等优点,适合在临床实验室推广应用。     

改良溴甲酚绿法测定血清清蛋白的建立

目的建立一种改良溴甲酚绿(BCG)法(以下简称改良法)测定血清清蛋白(ALB),能够应用于所有/多数自动生化分析仪,也可手工操作。方法测试吸收峰、最佳读数时间,以试剂:样品为100:1筛选系列浓度的BCG试剂,将线性良好的试剂作为试验试剂,测试其灵敏度、准确度、精密度、干扰试验及试剂有效期。结果吸收峰为627～628nm,最佳读数时间为30s,BCG浓度为0.35mmol/L的试剂的灵敏度为0.1g/L,线性范围为0.1～80.0g/L(Y=0.0232X+0.0055,r=0.9998),回收率为95.6%～105.2%(x=100.4%,s=2.4),不准确度为0.71%,方法学对照试验:回归方程为Y=0.9594X+1.5078,r=0.9948,日内CV=1.42%,日间CV=2.65%,干扰试验:标本中血红蛋白(Hb)≤4.0g/L、三酰甘油(TG)≤5.83mmol/L、胆红素(BIL)≤702μmol/L、维生素C(VC)≤17613μmol/L时对实验无干扰。结论方法学评价试验结果表明,改良法的灵敏度、线性、准确度、精密度均优良,有较强的抗干扰能力,试剂有效期为半年,由于试剂样品比例合适,固能够应用于所有/多数自动生化分析仪,也可手工操作。     

糖化血红蛋白不同测定法的评价

目的对3种测定糖化血红蛋白的方法进行方法学评价.方法用离子交换高效液相层析(HPLC)法(X)、微柱亲和层析手工法(Y1)、胶乳凝集免疫法(Y2)测定糖化血红蛋白,进行线性范围、回收率、精密度、干扰因素及参考范围的分析.结果 X、Y1、Y2法的线性范围分别为2.8%～18%、3.6%～15.3%、2.3%～15.5%.3种方法的平均回收率均在95%～104%以内,批内、批间平均变异系数(CV)均<5%.10.2 mmol/L三酰甘油、8.0 mmol/L胆固醇、684 μmol/L胆红素、10.1%的HbF对3种方法均无干扰.Y1法测定结果显著高于X法(P<0.01),回归方程Y1=1.15X-0.17(r=0.86,P<0.01);Y2法与X法的测定结果差异有显著性(P<0.05),Y2法的测定结果偏低,回归方程Y2=1.04X-0.69(r=0.92,P<0.01);X、Y1、Y2法的参考范围分别是4.3%～6.7%、3.5%～8.3%、3.6%～6.7%.结论与HPLC法相比,微柱亲和层析手工法测定结果偏高,而胶乳凝集免疫法的测定结果偏低.     

双光径免疫浊度分析仪测定尿视黄醇结合蛋白

目的 评价国产试剂在双光径免疫浊度分析仪(IMMAGE 800)上检测尿视黄醇结合蛋白(RBP)的可行性.方法 对瑞源公司生产的RBP试剂在IMMAGE800上的检测精密度、准确度、线性、干扰性进行评价,并与日立7170型自动生化分析仪的检测结果进行相关性分析.结果 低值、高值RBP的批内CV分别为4.78%,3.47%,批间CV分别为6.78%,5.70%;在RBP浓度为0.62 mg/L和2.36 mg/L的2份样本中,加入2.50 mg/L的标准品,其回收率分别为90.6%,96.4%;用高浓度的参考物做线性测定,日立7170与IMMAGE800的检测范围分别为:(0.25～7.80)mg/L和(0.16～9.20) mg/L之间;在尿液中Hb< 5.0 g/L时,对该法无明显干扰.40份标本分别在日立7170和IMMAGE800上检测RBP,结果经配对资料t检验,两者存在显著差异(P<0.01),将两组数据进行线性回归分析,显示出良好的相关性,回归方程为Y=0.906 4X+0.098,r=0.991,P<0.01.结论 应用国产试剂在IMMAGE800上检测尿RBP,其精密度、准确度、线性均符合临床要求,与日立7170的检测结果相比有良好的相关性,且具有更高的检测上限,可以替代日立7170型自动生化分析仪的检测.     

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。     

糖化血红蛋白不同测定法的评价

目的　对 3种测定糖化血红蛋白的方法进行方法学评价。方法　用离子交换高效液相层析 (HPLC)法 (X)、微柱亲和层析手工法 (Y1)、胶乳凝集免疫法 (Y2 )测定糖化血红蛋白 ,进行线性范围、回收率、精密度、干扰因素及参考范围的分析。结果　X、Y1、Y2 法的线性范围分别为 2 .8%～ 18%、3.6 %～ 15 .3%、2 .3%～15 .5 %。3种方法的平均回收率均在 95 %～ 10 4 %以内 ,批内、批间平均变异系数 (CV )均 <5 %。 10 .2mmol/L三酰甘油、8.0mmol/L胆固醇、6 84 μmol/L胆红素、10 .1%的HbF对 3种方法均无干扰。Y1法测定结果显著高于X法 (P <0 .0 1) ,回归方程 :Y1=1.15X - 0 .17(r =0 .86 ,P <0 .0 1) ;Y2 法与X法的测定结果差异有显著性(P <0 .0 5 ) ,Y2 法的测定结果偏低 ,回归方程 :Y2 =1.0 4X - 0 .6 9(r =0 .92 ,P <0 .0 1) ;X、Y1、Y2 法的参考范围分别是 4 .3%～ 6 .7%、3.5 %～ 8.3%、3.6 %～ 6 .7%。结论　与HPLC法相比 ,微柱亲和层析手工法测定结果偏高 ,而胶乳凝集免疫法的测定结果偏低。     

液体试剂与干粉试剂酶法测定血清总二氧化碳的实验对比

目的　评价液体试剂与干粉试剂酶法测定血清总二氧化碳 (TCO2 )的可靠性。方法　依据美国国家临床实验室标准化委员会 (NCCLS)有关文件对 2种试剂测定血清TCO2 进行相关性比较并对其线性、精密度进行评价。结果　液体试剂与干粉试剂相关良好 (r =0 .976 0 ) ,预期相对偏差在 15mmol/L时为 0 .0 7% ,在 2 5mmol/L时为 0 .16 % ,在 5 0mmol/L时为 0 .2 2 %。 2种试剂的线性范围均较宽 ,线性回归方程分别为Y =0 .995 9X - 1.4 2 92和Y =0 .9787X - 0 .5 74 8,r分别为 0 .9998和 0 .9997。 2种试剂的精密度均很好 ,其批内不精密度及总不精密度 (CV)均 <6 .1%。结论　液体试剂与干粉试剂测定血清中的TCO2 的相关性、线性、精密度均很好 ,具有可比性 ,而液体试剂使用更为方便。     

速率法检测血清α-L-岩藻糖苷酶（AFU）改良试剂中添加烷基糖苷的实验性能评价

目的 探讨添加烷基糖苷(alkyl glycosides,APG)改良试剂速率法检测血清α-L-岩藻糖苷酶(α-L-fucosidase,AFU)的实验性能评价。方法 通过优化反应体系,对速率法检测AFU改良试剂的精密度、线性范围、干扰性、结果比对及稳定性进行实验。结果 改良试剂精密度为批内CV低中高值分别为2.10%,1.19%和0.67%;批间CV低中高分别为2.62%,1.90%和1.20%,且两组试剂结果表明差异均有统计学意义(均P<0.01)。线性实验显示方程为Y=1.0045X-0.548 5,相关系数r²=0.999 7,线性范围0～300U/L。干扰实验表明样本中抗坏血酸≤12g/L,胆红素≤550μmol/L,脂血指数≤0.5mg/L,血红蛋白≤3g/L,对改良试剂无干扰。同时与进口试剂比对实验回归方程为Y=0.9978 X+0.085 3,相关性良好(r²=0.999 8)。稳定性实验结果显示改良试剂在2～8℃存放12个月测定结果稳定,CV_低值=1.04%,CV_高值=1.1...     

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。     

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.     

Dissociable correlates of two classes of retrieval processing in prefrontal cortex

Although substantial evidence suggests that the prefrontal cortex (PFC) implements processes that are critical for accurate episodic memory judgments, the specific roles of different PFC subregions remain unclear. Here, we used event-related functional magnetic resonance imaging to distinguish between prefrontal activity related to operations that (1) influence processing of retrieval cues based on current task demands, or (2) are involved in monitoring the outputs of retrieval. Fourteen participants studied auditory words spoken by a male or female speaker and completed memory tests in which the stimuli were unstudied foil words and studied words spoken by either the same speaker at study, or the alternate speaker. On "general" test trials, participants were to determine whether each word was studied, regardless of the voice of the speaker, whereas on "specific" test trials, participants were to additionally distinguish between studied words that were spoken in the same voice or a different voice at study. Thus, on specific test trials, participants were explicitly required to attend to voice information in order to evaluate each test item. Anterior (right BA 10), dorsolateral prefrontal (right BA 46), and inferior frontal (bilateral BA 47/12) regions were more active during specific than during general trials. Activation in anterior and dorsolateral PFC was enhanced during specific test trials even in response to unstudied items, suggesting that activation in these regions was related to the differential processing of retrieval cues in the two tasks. In contrast, differences between specific and general test trials in inferior frontal regions (bilateral BA 47/12) were seen only for studied items, suggesting a role for these regions in post-retrieval monitoring processes. Results from this study are consistent with the idea that different PFC subregions implement distinct, but complementary processes that collectively support accurate episodic memory judgments.     

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.     

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.