癌胚抗原两种不同检测方法的比较

目的评价电化学发光免疫分析法(ECLIA)、放射免疫分析法(RIA)在测定血清癌胚抗原(CEA)中的应用。方法分别用RIA法和电化学发光法检测120份患者血清标本中癌胚抗原浓度和质控品及标准品中的CEA浓度,作精密度和线性分析及比对分析。结果 RIA法和化学发光法检测CEA结果的差异无统计学意义(P0.05),两者具有良好的相关性(r=0.988);RIA法的线性范围和精密度不及ECLIA。结论 RIA法CEA结果与电化学发光法结果一致,而RIA法费用低,符合医院的临床要求。     

时间分辨荧光免疫法和电化学发光法检测AFP的比较

目的 对时间分辨荧光免疫分析法(TRFIA法)国产试剂盒与电化学发光免疫分析法(ECLIA法)检测血清AFP作比较分析,了解两种方法 特点.方法 分别采用国产TRFIA法试剂盒与ECLIA法检测正常人50例、肝癌患者40例血清AFP的含量:用高、中、低3种浓度AFP标准品采用两种方法 进行批内测定,n=10,观察重复性,所得结果 计算CV值;将高值标准品血清(250 ng/ml)按1:1比例加入每份正常对照组血清中,肝癌组病人血清与生理盐水按1:1稀释后再按1:1比例加入高值标准品血清(250ng/ml).每份检测2 次(TRFIA法)取平均值,计算回收率.结果 肝癌组AFP值(TRFIA法:558±319.10ng/ml;ECLIA法:552.31±302.67g/ml)明显高于正常组(TRFAIA:6.51+5.42ng/ml;ECLIA法:6.32±5.14ng/m)(P<0.05),两种方法 结果 无显著差异(P>0.05).其相关系数为0.9150,测定结果 呈正相关.高、中、低3种浓度标准品的重复性试验TRFIA法与ECLIA批内变异系数分别低于7.9%和3.1%,后者优于前者,两种方法 略有不同.无明显差异(P>0.05).回收试验结果 ,TRFIA法回收率在92.3%～103.9%.结论 国产TRFIA法试剂盒和ECLIA法检测AFP相比较具有良好的相关性,灵敏度和稳定性也较好,可应用于临床血清AFP检测.     

3种化学发光检测系统测定血清糖链抗原125的比较

目的探讨血清糖链抗原125(CA125)临床测定结果在3种化学发光检测系统间的可比性,并确定其相关性。方法选取100例患者血清,分别使用化学发光酶免疫分析法(CLEIA)、电化学发光免疫检测法(ECLIA)和直接发光免疫分析法(CLIA)进行CA125检测,对各组数据进行相关性分析与中位数比较。结果 3组结果中任意两组之间均存在相关性,对3组样本间中位数进行比较,结果显示3组之间差异有统计学意义(P<0.05),CLE-IA组显著高于ECLIA组与CLIA组,差异有统计学意义(P<0.05),而ECLIA组与CLIA组之间差异无统计学意义(P>0.05);以大于或等于35U/mL即判断为阳性,CLEIA组阳性率为76%(76/100),ECLIA组阳性率为58%(58/100),CLIA组阳性率为53%(53/100),CLEIA组阳性率显著高于ECLIA组与CLIA组,差异有统计学意义,而ECLIA组CLIA组阳性率差异无统计学意义。结论建议对CA125建立标准化的参考系统,现有的检测系统应与标准化的参考系统进行比对。     

ECLIA与RIA测定人血清甲状腺自身抗体的结果分析

目的:ECLIA与RIA测定人血清甲状腺自身抗体的结果分析。方法:临床诊断甲状腺功能检查及病理金标准确诊35例HT样本,28例GD样本及13例其他内分泌疾病的样本,15例正常对照组。按诊断试验常用指标:对ECLIA与RIA测定TgAb、TpoAb值敏感度、特异度、准确度和似然比等进行分析。结果:①ECLIA测定TgAb、TpoAb的敏感度、特异度均在90%以上显著高于RIA(75%);两种方法分别检测76例样本,经配对资料的χ2检验:ECLIA测定的TgAb与RIA测定TGA,P<0·05;ECLIA测定的TpoAb与RIA测定MCA,P<0·05;两种方法的阳性检出率均存在显著差异。②ECLIA测定TpoAb阳性率显著高于ECLIA测定TgAb阳性率,更显著高于RIA测定TgAb、MCA阳性率。③由两种方法计算准确度TgAb、TpoAb,ECLIA(91·2%,94·5%)高于RIA(78%,78%),两种方法测定TgAb、TpoAb的一致率基本是匹配的。两者间计算TgAb、TpoAb阳性、阴性预测值ECLIA高于RIA。结论:ECLIA特异性、灵敏性、准确度、阳性率显著优于RIA;ECLIA检测TpoAb诊断HT比TgAb更有优势。     

Cobas E602电化学发光免疫分析仪检测HBcAb结果分析

目的 通过Cobas E602电化学发光免疫分析法（ECLIA）与酶联免疫吸附法（ELISA）对临床标本对比检测分析,探讨ECLIA检测HBcAb的结果意义模式,为临床提供科学的指导意义,同时确保同一实验室内同一项目结果的一致性.方法 收集60例患者标本,用ECLIA法分别同时测定原倍血清和1∶30稀释后血清,与临床常用的ELISA法测定1∶30稀释后血清的结果进行对比统计分析.结果 ECLIA法测得原倍血清的HBcAb阳性率（48.3%）明显高于ECLIA法和ELISA法测定1∶30稀释后血清阳性率（35.0%和38.3%）,两者差异有统计学意义（χ2=8.53,P〈0.01）,两种方法同时测定原倍血清和1∶30稀释后血清中的HBcAb阳性符合率分别为93.4%和91.4%,差异无统计学意义（χ2=1.29,P〉0.05）.结论 ECLIA法定量测定乙肝时,HBcAb测定标本必须用1∶30稀释后的血清,确保同一实验室内ECLIA法与ELISA法检测结果的一致性.     

HBV纤维化患者HA、LN、PⅢP、CⅣ结果分析

目的探讨放射免疫法(RIA)血清纤维化标志物在乙型肝炎病毒(HBV)引起肝纤维化(HF)患者的诊断价值。方法选取2014年1月至2015年12月该院采取RIA检测血清纤维化标志物诊断HBV患者397例进行回顾性分析,以肝活检穿刺病理结果作为HF分期标准,分别比较各分期患者的血清透明质酸(HA)、层黏蛋白(LN)、Ⅲ型前胶原肽(PⅢP)、Ⅳ型胶原(CⅣ)水平,并分析血清纤维标志物诊断HF的临床价值。结果肝脏穿刺后病理检查检出S0期43例、S1期167例、S2期102例、S3期64例、S4期21例,不同分期的HBV患者血清HA、PⅢP、CⅣ水平差异具有统计学意义(P0.05),均随着HF分期的升高而升高;不同分期的HBV患者血清LN水平差异无统计学意义(P0.05);HBV患者血清HA、PⅢP、CⅣ水平与患者纤维化程度分期呈显著的正相关关系(P0.05);LN与患者的纤维化程度分期无相关性(P0.05);血清HA、PⅢP、CⅣ水平诊断HBV患者HF的灵敏度为64.12%、特异度为67.44%、漏诊率为35.88%、误诊率为32.56%。结论 RIA检测血清纤维化标志物诊断HBV患者纤维化具有无创性和一定的临床价值,可以作为穿刺活检的一种补充诊断手段。     

化学发光法测定绒毛膜促性腺激素的临床应用评价

目的 :为观察化学发光免疫分析法测定绒毛膜促性腺激素 (hCG)的临床使用价值。方法 :对全自动化学发光免疫分析系统 (automatedchemiluminescencesystem 180 ,简称ACS 180 )测定hCG值与放免法 (RIA)测定 β hCG值进行对照。并对 5 3例滋养细胞疾病血标本进行了化学发光法hCG测定。结果 :以化学发光法测定 β hCG药盒标准品 ,hCG测定值与标准品各浓度点呈显著相关 ,r =0 996 0 ;葡萄胎、绒癌转阴前血标本两法测定值亦存在一定的相关性。结论 :化学发光法测定hCG较RIAβ hCG药盒敏感 ,对葡萄胎、绒癌患者的诊治、随访有重要的临床意义。     

胱抑素C与肝硬化的相关性研究

目的 探讨研究血清胱抑素C与肝硬化的相关性,以及胱抑素C的变化与肝硬化不同阶段、程度的关联性。方法收集该院75例肝硬化患者的血清,采用颗粒增强散射免疫比浊法测定患者的血清胱抑素C、血清尿素氮和肌酐,同时选取其他患者人群血清作为对照组,观察分析测定指标与肝硬化之间的相关性;同时,分析研究不同肝硬化程度与血清胱抑素C之间的关联性。结果 肝硬化患者血清胱抑素C值明显高于对照组血清值,差异具有统计学意义(P<0.05);而血清尿素氮和肌酐值与对照组比较差异无统计学意义(P>0.05)。患者肝硬化的严重程度与血清胱抑素C值具有关联性,肝硬化程度越严重胱抑素C值越高,差异具有统计学意义(P<0.05)。结论 胱抑素C与肝硬化具有相关性,并且能够反映患者肝硬化的严重程度,给临床治疗提供一定的依据,并可作为评价患者肾功能的有效指标。     

危重症血糖的初步探讨

目的探讨危重患者不同组的血糖、血清胰岛素和C肽的差别,分析各组内血糖与胰岛素、C肽的相关性。方法选择2010年5月至2011年12月入住深圳市福田区人民医院ICU病房的222例危重患者,测定24 h内的血糖、血清胰岛素、C肽及进行急性生理和慢性健康状况Ⅱ评分(acute physiology and chronic health evaluationⅡ,APACHEⅡ评分)。按病史分为糖尿病组及对照组,比较两组间的血糖、血清胰岛素、C肽水平,分析不同组别的血糖与血清胰岛素、C肽的相关性。结果对照组血糖[(8.2±3.5)mmol/L]高于糖尿病组[(7.7±2.1)mmol/L],但两组比较差异无统计学意义(P>0.05);糖尿病组血清胰岛素[(67±110)μIu/ml]高于对照组[(11±8)μIu/ml],差异无统计学意义(P>0.05);对照组C肽[(4.6±1.0)μg/L]高于糖尿病组[(1.8±1.8)μg/L)],差异有统计学意义(P<0.05)。两组血糖与血清胰岛素、C肽无直线相关。结论 ICU危重症糖尿病与非糖尿病患者出现同样血糖、血清胰岛素。反应胰岛细胞功能的C肽,非糖尿病患者高于糖尿病患者。危重症患者血糖与血清胰岛素、C肽无线性相关。     

超敏C反应蛋白定标方式对检验结果影响的比较研究

目的 探讨超敏C反应蛋白(hsCRP)在日立7170A生化分析仪和贝克曼DXC800生化分析仪上的定标方式与检验结果的关系,以实现两台仪器检验报告的一致性.方法 在日立7170A生化分析仪上分别采用Spline和Exponential的定标方式定标,在贝克曼DXC800生化分析仪上采用Math Model 1和Math Model 3的定标方式定标,分别测定各浓度水平的hsCRP标准品3次和50份血清标本.结果 测定hsCRP标准品时,除零点以外,Math Model 1定标方式的测定值与标准品浓度之间的差异有统计学意义(P<0.05),而其他三种定标方式的测定值与标准品浓度之间的差异无统计学意义(P>0.05).测定hsCRP血清标本时,采用Math Model 3定标方式与Exponential定标方式的测定结果之间的差异有统计学意义(t=2.731,P<0.01),与Spline定标方式的测定结果之间的差异无统计学意义(t=0.946,P=0.349).结论 测定hsCRP时日立7170A采用Spline定标方式与贝克曼DXC800采用Math Model 3定标方式时的结果具有可比性,且能够满足临床诊断的需要.     

几种化学发光检测系统测定血清胰岛素和C-肽临床效果的评估

目的探讨不同化学发光检测系统测定血清胰岛素、C-肽临床结果间的可比性和符合程度,并试图找到不受方法学影响,能够反映两者动态变化规律的通用参数。方法选择40名做胰岛素和C-肽释放试验的患者（均未使用外源性胰岛素治疗）,同时应用三种化学发光免疫分析系统,检测同一个体在OGTT中各时间点血清胰岛素和C-肽的浓度,并分别计算两者在服糖后各时间点浓度与其空腹浓度的比值（简称比值）。结果①血清胰岛素或C-肽测定结果在任意两系统间的差异均非常显著（均为P〈0.001）,且高度相关（胰岛素：r=0.946-0.977;C-肽：r=0.959-0.996）。②服糖后同一时间点胰岛素的上述比值在任意两系统间均显著相关（均为P〈0.05）,且均无统计学差异（均为P〉0.05）,C-肽也可得到相似结果。③对于相同检测系统,同一时间点两者的上述比值间差异显著（P〈0.05）且C-肽的比值显著低于胰岛素。结论血清胰岛素或C-肽的测定结果在不同检测系统间差异很大,虽均具有很好的相关性,但不能互相通用。而在OGTT中,服糖后同一时间点两者浓度与各自空腹浓度的比值在不同检测系统间的差异似乎并不显著,有望成为不同检测系统间互认的指标。至于C-肽在反映胰腺β细胞功能的敏感度上显著低于胰岛素的问题,其临床应用尚有待进一步研究。     

The beta-cell response to glucagon and mixed meal stimulation in non-insulin dependent diabetes

The aim of this study was to evaluate the correlations of the C-peptide and insulin responses after stimulation with glucagon intravenously as well as the 24-h urinary excretion of C-peptide to the C-peptide response to a standard mixed meal in 30 patients with non-insulin dependent diabetes mellitus (NIDDM). Fasting plasma C-peptide as well as the C-peptide and insulin responses to glucagon, showed similar but only modest correlations with the C-peptide response to the meal. Urinary C-peptide showed no correlation with the C-peptide response to the meal, but correlated modestly with fasting plasma C-peptide (r = 0.55, p less than 0.01). The C-peptide and insulin responses after meal stimulation correlated modestly inversely with HbA1. In conclusion, measurement of C-peptide in fasting state, as well as measurements of C-peptide and insulin after glucagon stimulation, only modestly predict the C-peptide response to physiologic stimulation in NIDDM. Twenty-four-hour urinary C-peptide excretion does not predict this response. Patients with NIDDM seem to show a better metabolic control if they have a more pronounced beta-cell response to physiologic stimulation.     

Postprandial variations in serum bile acid levels in humans free of hepatic or intestinal diseases (author's transl)

The levels of unsulfated, free or conjugated cholic, deoxycholic and chenodeoxycholic acids were measured using gas chromatography in 39 humans free of hepatic or intestinal diseases before and 10, 60, 120 and 180 min after ingestion of a standard meal. The probable maximal levels were determined with an error risk lower than 0.05. In fasting subjects, the observed values are comparable with those obtained by other authors working with gas chromatography or radioimmunoassay. Meal ingestion does not influence in the same way the serum levels of the various bile acids: the chemodeoxycholic serum level rose significantly in all cases whereas cholic and deoxycholic serum levels rose only in two-thirds of observed subjects; 60 and 120 min after the meal for chenodeoxycholic acid, and only 60 min after the meal for cholic acid, the mean values are significantly higher than the fasting ones; 120 min after the meal, the chenodeoxycholic and total bile acid probable maximal levels (respectively 7.4 and 10.3 micrometer) are twice the fasting ones. The cholic to chenodeoxycholic serum level ratio is nearly always lower than 1 but may reach 3. On the basis of these results, the validity and efficacy of the exploration tests based on serum bile acid level determinations are discussed.     

饥饿大鼠脑杏仁核中瘦素受体的表达

背景饥饿是脂肪代谢的一个重要过程,可触发适应性反应,瘦素水平下降,但饥饿时脑中瘦素受体是否变化及变化情况尚不清楚.目的饥饿状态下瘦素受体表达的变化及杏仁基底外侧核和中央核的作用.设计随机对照的实验研究.地点和材料实验地点西安交通大学医学院.成年健康雄性SD大鼠20只,随机分为禁食24,48,72 h组和对照组,每组5只.干预措施各组大鼠禁食前后分别检测体质量,体长,尾长.采用放免法测定血清瘦素水平,免疫组化ABC法检测瘦素受体和神经细丝酸性蛋白(glial fibrillary acidic protein,GFAP)的表达情况.主要观察指标①各组大鼠体质量减少量,Lee指数,血清瘦素水平和血糖水平.②各组大鼠瘦素受体的表达.③各组大鼠星形胶质细胞GFAP的表达.结果禁食24 h血清瘦素由(2.49±0.60)μg/L下降至(1.26±0.97)μg/L,体质量减轻4.22%,48 h和72 h体质量分别减轻12.15%和19.70%,血清瘦素分别降至(0.78±0.19)μg/L和(0.62±0.16)μg/L.与正常大鼠相比,禁食24 h杏仁基底外侧核瘦素受体表达增强[LR-IR细胞数(131±8.9)个/mm2,(68±10.4)个/mm2],禁食48 h瘦素受体表达水平(82±12.6)个/mm2接近正常大鼠,禁食72 h瘦素受体阳性细胞明显减少(49.0±7.4)个/mm2.杏仁中央核瘦素受体表达在禁食前后差异无显著性意义.禁食24 h和48 h杏仁基底外侧核GFAP染色阳性细胞数目与对照组大鼠比较差异无显著性意义.结论饥饿时在血清瘦素水平下降时,杏仁基底外侧核瘦素受体表达上调.饥饿可能调节杏仁基底外侧核对瘦紊的敏感性.     

"Method-specific" stability of serum C-peptide in a multicenter clinical study

A Central laboratory that participates in multicenter clinical studies must consider and study the parameters that condition the in vitro stability of the analytes. We evaluated the effect of temperature on serum C-peptide storage during transport from clinical research centers to the Central laboratory. In particular, the stability for storage lengths from 0 to 24-48 hours at temperatures of between -20 degrees C and +37 degrees C were studied: the C-peptide assay was performed by means of a chemiluminescence and a RIA method. The tests confirmed that sample freezing is the gold standard for accurate determination of serum C-peptide and that storage at 37 degrees C may decrease the analyte levels. Instead, C-peptide stability at 2-8 degrees C appeared "method-specific"; while no apparent alteration was obtained with the chemiluminescence method up to 24 hours of storage, the RIA showed an early slight increase in C-peptide that is proportionate to storage time. Our work highlights that before starting up a multicenter clinical study it is always necessary to optimize and standardize biological sample storage and transport conditions to guarantee a high quality sample for analysis. Beyond this, it is even very useful to check the reliability of technical and instrumental resources that the Central laboratory will use during the study because molecular alterations of the analytes due to variable storage conditions can cause misleading results.     

饮食前后服氯氮平血药浓度对照研究

目的：比较研究饮食前后服氯氮平的药代动力学和生物利用度。方法：采用交叉给药方案，19例精神分裂症病人空腹或餐后服用氯氮平，用HPLC测定血药浓度，并作副反应量表测定。结果：饭前服氯氮平达峰时间缩短，高峰浓度升高，生物利用度提高，两种服药方法间差异显性（P＜0．05）。结论：饭前服药使较小的剂量达到治疗血药浓度，这样较快地控制精神症状，又减低了药物用量，可减少药物副反应。     

Automated chemiluminescent assay for C-peptide

C-peptide is secreted in equimolar concentrations with insulin, and is often measured to assess pancreatic beta-cell function. C-peptide analysis is most often performed by radioimmunoassay (RIA) which has several disadvantages. We evaluated an automated, chemiluminescent immunoassay for C-peptide in terms of precision, linearity, interference, and correlation with a RIA method. The chemiluminescent assay demonstrated acceptable correlation with the RIA method (slope = 0.82, y-intercept = 0.88 ng/ml, r-value = 0.97). Between-run Cvs ranged from 8 to 9%, which compared well with the RIA method. Linearity extended beyond the manufacturer's recommendations and recovery ranged from 87 to 112% across the concentrations tested, with a slope of 1.007. No significant interference was noted with hemoglobin, bilirubin, or triglyceride. Overall this method compared favorably with the RIA method and offers an alternative to RIA for the analysis of C-peptide.     

Decreased serum C-peptide/insulin molar ratios after oral glucose ingestion in hyperthyroid patients

Since C-peptide/immunoreactive insulin (IRI) molar ratios may reflect hepatic extraction of insulin, we measured simultaneous serum glucose, IRI, and C-peptide levels during fasting and 30, 60, 90, 120, and 180 min after 75 g of oral glucose in 10 hyperthyroid patients and 10 age- and weight-matched controls. Mean fasting serum glucose and IRI levels were significantly higher in the hyperthyroid versus control subjects (glucose: 4.9 +/- 0.3 mmol/L versus 4.36 +/- 0.11 mmol/L, P less than 0.01; IRI: 0.10 +/- 0.02 pmol/ml versus 0.05 +/- 0.01 pmol/ml; P less than 0.025). After glucose, mean serum glucose levels were significantly higher in the hyperthyroid versus control subjects at all times studied except for 180 min (P less than 0.01). Mean IRI levels were significantly higher at all times studied including 180 min (P less than 0.01). Mean fasting C-peptide levels were significantly greater in the hyperthyroid patients compared with the controls (1.2 +/- 0.25 pmol/ml versus 0.62 +/- 0.09 pmol/ml; P less than 0.025). After oral glucose, mean C-peptide levels were significantly higher (P less than 0.025) in the hyperthyroid compared with control subjects at 30-60 min but not at 90-180 min. Molar ratios of C-peptide/IRI were significantly lower (P less than 0.05) in the hyperthyroid versus control subjects at all times studied except fasting. In summary, glucose intolerance and hyperinsulinism occur in hyperthyroidism. In addition, C-peptide/IRI molar ratios are reduced after oral glucose ingestion.     

Enzymic measurement of primary bile acids and the primary bile acid ratio in serum with the IL-Multistat III Fluorescence Light-Scattering Centrifugal Analyzer

Enzymic fluorimetric methods are described for the determination of primary bile acids and of chenodeoxycholic acid (CDC) and cholic acid (C) in serum. Bile acids are extracted from 0.3 mL of serum in a simple 5-min step with use of Sep-Pak C cartridges. Total primary bile acids are measured by an equilibrium technique after reaction with beta-NAD in the presence of 7 alpha-hydroxysteroid dehydrogenase. Chenodeoxycholic acid (and its conjugates) is measured by a reaction-rate technique employing the same reaction as above but under different experimental conditions. A small contribution of cholic acid (and its conjugates) to the reaction rate is eliminated by simple calculations. Cholic acid is calculated by difference of the two determinations. In both assays NADH fluorescence is measured with the Multistat centrifugal analyzer. Absolute recovery of bile acids from serum was about 87%. Day-to-day standard deviations for CDC and C were 1.6 and 2.0 mumol/L at serum concentrations of 22.1 and 24.1 mumol/L respectively. Comparison data with a cholylglycine RIA procedure gave the following correlation coefficients (x = RIA, y = proposed method): r = 0.980 (RIA vs total primary bile acids), r = 0.918 (RIA vs CDC) and r = 0.989 (RIA vs C). The methods described appear more practical for use on a routine basis than methods in the literature for the calculation of the primary bile acid ratio.