3种HBsAg血液筛查试剂的检测效能评估

目的:对使用的3种HBsAg(2种酶免试剂+1种化学发光试剂)进行检测效能评估。方法:通过分析这3种HBsAg试剂对9个HBsAg血清盘(792个标本)的检测结果,分析3种试剂的批间精密度、批内精密度及其灵敏度、特异度及其正确率、假阳性例数和假阴性例数,最终比较3种试剂检测效能。结果:对于强阳性质控标本,3种试剂的批间精密度良好,变异系数在5.1%～10.2%。由于ELISA2对于弱阳性质控标本未能检出,因此ELISA2在批间精密度和批内精密度的统计中不计入内。对于弱阳性质控,ELISA1与CLIA的批间精密度分别为16.2%和21.7%。批内精密度的变异系数分别为10.9%和12.6%。对于亚型标本的分析,ayw1亚型的标本ELISA试剂1的检出下限是0.18IU/mL,ELISA试剂2的检出下限是0.36IU/mL,CLIA试剂的检出下限是0.09IU/mL。adw2亚型的标本ELISA试剂1的检出下限是0.09IU/mL,ELISA试剂2的检出下限是0.09IU/mL,CLIA试剂的检出下限是0.05IU/mL。adrq亚型的标本ELISA试剂1的检出下限是0.05IU/mL,ELISA试剂2的检出下限是0.09IU/mL,CLIA试剂的检出下限是0.05IU/mL。对于突变标本,3种试剂的检出率为42.3%～88.5%,其中CLIA检出率为88.5%。在611例常规血清盘标本,3种HBsAg试剂灵敏度为78.7%～87.5%,特异性为96.3%～98.4%,准确率为84.9%～90.2%,其中ELISA2的正确率最低为84.9%,假阳性例数为3～6例,假阴性例数为41～88例,其中CLIA的假阴性例数最少为6例。结论:CLIA试剂对于突变标本和亚型标本具有很好的检出能力。HBsAg试剂在使用前及使用中均要进行必要的评估,化学发光试剂在HBsAg检测中具有一定优势。     

3种HBsAg血液筛查试剂的检测效能评估

目的:对使用的3种HBsAg(2种酶免试剂+1种化学发光试剂)进行检测效能评估。方法:通过分析这3种HBsAg试剂对9个HBsAg血清盘(792个标本)的检测结果,分析3种试剂的批间精密度、批内精密度及其灵敏度、特异度及其正确率、假阳性例数和假阴性例数,最终比较3种试剂检测效能。结果:对于强阳性质控标本,3种试剂的批间精密度良好,变异系数在5.1%～10.2%。由于ELISA2对于弱阳性质控标本未能检出,因此ELISA2在批间精密度和批内精密度的统计中不计入内。对于弱阳性质控,ELISA1与CLIA的批间精密度分别为16.2%和21.7%。批内精密度的变异系数分别为10.9%和12.6%。对于亚型标本的分析,ayw1亚型的标本ELISA试剂1的检出下限是0.18IU/mL,ELISA试剂2的检出下限是0.36IU/mL,CLIA试剂的检出下限是0.09IU/mL。adw2亚型的标本ELISA试剂1的检出下限是0.09IU/mL,ELISA试剂2的检出下限是0.09IU/mL,CLIA试剂的检出下限是0.05IU/mL。adrq亚型的标本ELISA试剂1的检出下限是0.05IU/mL,ELISA试剂2的检出下限是0.09IU/mL,CLIA试剂的检出下限是0.05IU/mL。对于突变标本,3种试剂的检出率为42.3%～88.5%,其中CLIA检出率为88.5%。在611例常规血清盘标本,3种HBsAg试剂灵敏度为78.7%～87.5%,特异性为96.3%～98.4%,准确率为84.9%～90.2%,其中ELISA2的正确率最低为84.9%,假阳性例数为3～6例,假阴性例数为41～88例,其中CLIA的假阴性例数最少为6例。结论:CLIA试剂对于突变标本和亚型标本具有很好的检出能力。HBsAg试剂在使用前及使用中均要进行必要的评估,化学发光试剂在HBsAg检测中具有一定优势。     

胰腺癌血清PerioStin水平与淋巴结转移的关系

目的 探讨胰腺癌血清Periostin( PN)水平与淋巴结转移的关系.方法 采用ELISA检测血清中PN水平,并进行自制ELISA试剂盒的指标评价.结果 ELISA法检测PN的最小检出限为4.903 ng/ml,标准曲线方程式曲线拟合度R2 =0.968.平均批内变异系数为7.6％,平均批间变异系数为13.15％,回收率为82％ ～ 92％.健康对照者31例的血清PN含量为(22.0±6.8) ng/ml,18例胰腺癌患者的血清PN含量为(37.9±20.9) ng/ml,18例有远处转移的胰腺癌患者的血清PN含量为(45.6±25.8) ng/ml.胰腺癌患者与健康对照者间有显著性差异(P＜0.05),而18例胰腺癌患者与健康对照者和18例有远处转移的胰腺癌患者组间也有显著性差异(P＜0.05).结论 PN-ELISA试剂盒具有良好的灵敏性、特异性和准确性.PN与肿瘤转移有密切关系,且PN蛋白水平的检测可以用于判断胰腺癌和作为诊断胰腺癌是否出现淋巴结转移的指标.     

快速放免法测定血清生长激素

本文介绍了一种快速放免测定血清hGH方法。其在我科84年建立的放免测定hGH方法基础上进行了改进。28小时即可出报告,是目前国内报告中比较适用于临床的最快的一种hGH测定法。经方法学鉴定,本法回收率在98～103％、灵敏度0.3ng/ml,批内25、10、40ng/mg的CV％分别为8.7、4.7、3.7;批间分别为4.7、9.5、8.1。12条标准曲线r=-0.9996、a=2.7250、b=-2.4250。经对108人次的血样品同时用快速法及原方法进行测定,结果显示:两方法间无显著性差异(P>0.7),其相关密切(P<0.01)。     

单克隆抗体双位点夹心ELISA测定人血清载脂蛋白E的研究

利用自制的抗人载脂蛋白E(apoE)单克隆抗体,建立了单克隆抗体双位点夹心ELISA测定apoE的方法,并对该方法的特异性、准确度、精密度和灵敏度进行了评价。载脂蛋白AⅠ、AⅡ、B、CⅠ、CⅡ、CⅢ不干扰测定,检测下限10ng,回收率101.2％,批内变异系数CV=5.9％,批间CV=8.1％。并测定了1048例正常人和各种疾病患者血清apoE含量。     

应用ELISA方法检测老年动脉粥样硬化患者血清抗负电性低密度脂蛋白自身抗体含量

目的建立一种通过酶联免疫吸附法(ELISA)定量测定动脉粥样硬化患者血清中抗负电性低密度脂蛋白〔LDL(-)〕自身抗体含量的方法。方法从老年动脉粥样硬化患者血清中纯化得到LDL(-),吸附到96孔板用于特异性捕获抗LDL(-)自身抗体。对酶联免疫吸附的最低检测限(LOD)、定量限(LOQ)、批内和批间的精密度以及准确度、回收率进行评价。结果抗LDL(-)-ELISA分析法线性回归方程为y=1.250 4x+3.292 6(R2=0.994),线性范围在为0.004～0.125 mU/L。批内和批间的精密度和准确度、回收率均符合免疫分析要求。结论本文建立的ELISA方法可用于老年动脉粥样硬化患者血清内抗LDL(-)自身抗体的定量分析、临床研究和生化调查。     

量化检测日本血吸虫循环抗原的初步研究

目的探索量化检测日本血吸虫循环抗原的方法。方法用AWA-PcAb/MG2双抗体夹心ELISA(S-ELISA)检测SEA-TCA抗原,并根据测得的OD490值和相应抗原浓度计算回归方程式,再用该法和fSjc26GST-PcAb双抗体夹心ELISA方法检测急慢性日本血吸虫病人的血清循环抗原。并初步应用于检测流行区和传播阻断地区的人群血清循环抗原。结果AWA-PcAb/MG2双抗体夹心ELISA测得SEA-TCA浓度(y)与OD490值(x)呈明显的正相关(r=0.981,y=128.08x-46.95);血清循环抗原的平均含量,急性血吸虫病人(206.27±36.62 ng/ml)显著高于慢性血吸虫病人(122.88±75.13 ng/ml)。两组双抗体S-ELISA检测急性血吸虫病人循环抗原的阳性率均为100%(34/34),慢性血吸虫病人循环抗原的阳性率则分别为87.50%(70/80)和78.57%(63/80),特异性分别为90.74%(98/108)和92.59%(100/108)。用以上两法对流行区和传播阻断地区的人群血清进行循环抗原检测,其阳性率分别为34.52%(87/252)和9.72%(49/504),具有显著性差异。结论两组双抗体S-ELISA用于检测日本血吸虫循环抗原均有较好的效果,其中AWA-PcAb/MG2双抗体夹心ELISA能量化检测日本血吸虫循环抗原。     

微波消解石墨炉原子吸收改进法检测茶饮料中铅含量方法探讨

目的 探讨微波消解石墨炉原子吸收改进工作曲线法检测茶饮料中铅含量的方法.方法 先用标准曲线法直接测定稀释后茶饮料中铅的含量,计算其含量范围,确定样品消解取样量及加标量,空白、标准储备液、样品和3个加标样经微波消解定容,采用磷酸二氢铵做基体改进剂,石墨炉原子吸收改进工作曲线法测定消解后茶饮料及加标样中铅的吸光度.结果 在0～50 μg/L铅工作曲线的线性方程是y=0.00368+0.00272x,相关系数r=0.9990,在5～20μg/L添加范围内平均加标回收率为97.5％～ 103.0％,精密度为1.40％～ 2.26％,测定茶饮料质控样品A309含量为0.0651 mg/L;标准加入法曲线方程为y=0.03536+0.00268x,验证茶饮料质控样品A309含量为0.0642 mg/L;工作曲线和标准加入法斜率和结果的相对标准偏差差异无统计学意义(F=0.094,P=0.770);运用该方法检测同批类不同浓度茶饮料质控样品A356,结果符合质控赋值范围要求.结论 一次性微波消解,运用工作曲线法测定样品中铅的含量,标准加入法验证,检验结果通过了能力验证考核,该方法可在茶饮料样品检测中加以运用.     

时间分辨荧光免疫分析法和酶联免疫吸附实验法测定乙型肝炎病毒大蛋白的方法学比较

目的对时间分辨荧光免疫分析(time-resolved fluoroimmunoassay,TRFIA)和酶联免疫吸附实验(enzyme-linked immunosorbent assay,ELISA)检测乙型肝炎患者血清中病毒大蛋白(hepatitis B virus large surface protein,HBV-LP)进行方法学比较。方法收集30例正常体检血清标本作为阴性对照和150例慢性乙型肝炎患者血清标本,利用ELISA法检测HBV-LP,将其中70例阳性标本作为阳性样本,70例阴性标本作为阴性样本,再分别采用TRFIA法检测HBV-LP,对二者的灵敏度、特异度、一致性、检测线性范围、精密度、相关性及两种试剂盒的稳定性进行比较。其中TRFIA与ELISA结果不一致的12例标本采用PCR法进行验证。结果TRFIA检测HBV-LP的最小测定值为0.1 ng/ml,ELISA检测HBV-LP的最小测定值为2.5 ng/ml,二者的特异度均为100%。TRFIA和ELISA检测HBV-LP的Kappa值为0.83。12例ELISA和TRFIA检测不一致的标本,经PCR验证后有10例HBV DNA103拷贝数。TRFIA试剂检测的线性范围在0.625~10 252 ng/ml之间,ELISA试剂盒检测的线性范围在5~1 281.6 ng/ml。TRFIA法检测高、中、低3个浓度水平的批内CV平均为6.10%,ELISA法的批内CV平均为8.98%。TRFIA批间CV平均为6.91%,ELISA的批间CV平均为10.45%。TRFIA试剂盒的结合下降率为6.61%,ELISA试剂盒的结合下降率为23.59%。结论 TRFIA与ELISA具有高度的一致性,但是两者相比,前者有更高的灵敏度和精密度,且TRFIA试剂盒的稳定性更好。     

在线固相萃取——高效液相色谱法测人血清中氯氮平浓度

目的 建立在线固相萃取(SPE)预处理的高效液相色谱法,检测血清中氯氮平浓度.方法 以乙腈、超纯水、H20(100 mM NH4Ac)作为流动相,采用梯度洗脱的原理,将血清中氯氮平经SPE柱前处理提取,再反冲入分析柱进行色谱分析.结果 血清中氯氮平的最低检测限位1.5 ng/mL(S/N=3),低中高三种浓度方法回收率平均为93.58％、98.06％、98.32％,批内批间相对标准偏差(RSD％)分别为1.17、1.33、1.81,r=0.9 997,线性范围:10～1600 ng/mL.结论 该方法操作简便、快速、精确、自动化程度高,适用于临床大批量血药物浓度标本的检测工作.     

综合医院HIV抗体筛查阳性样本的分析

目的分析综合医院艾滋病病毒（HIV）抗体筛查阳性样本的特征。方法分别用中山、梅里埃、丽珠三种酶联免疫吸附试验（ELISA）试剂和雅培硒标试剂筛查HIV抗体,筛查阳性样本用蛋白印迹法（WB）进行确认。分析确认阳性、不确定、阴性三组样本的特征。结果2004年1月至2009年3月共检测HIV抗体192636例,其中阳性样本349例。确认阳性组174例,流行率0．090％;2006—2008年显著高于2004—2005年（Χ^2=11．35,P=0．001）,以21～50岁的青壮年男性居多。ELISA试剂均为阳性,S／CO值为（12．89±3．14）;雅培试剂均为阳性;WB结果显示,91．38％HIV感染者呈现7条带以上。阳性一不确定组20例,ELISA试剂均为阳性,S／CO值为（4．90±3．40）;雅培试剂7例阳性;呈现p24带者18例（90．00％）,gp160带7例（35．00％）,gp120、p17带各1例（各5．00％）,其余带未呈现。1例随访后转阳性,3例随访转阴性。阳性阴性组155例,心脏病人所占比例最高（26．45％）。ELISA试剂均为阳性,S／CO值为（2．63±2．54）;雅培试剂15例阳性。结论HIV感染人数逐年增加;筛查阳性样本中存在一定的不确定、假阳性结果,应按规定程序进行确认。     

HIV抗体筛查试剂联合检测替代免疫印迹法的对比分析

目的探讨用两种不同厂家或原理的HIV抗体初筛试剂联合检测,以替代免疫印迹法(WB),用于检测某些高危人群或特殊人群。方法用包括快速检测和酶联免疫吸附试验(ELISA)试剂在内的9种HIV抗体筛查试剂,对200份样本进行联合检测,对任意一种试剂检测阳性的样本进行WB检测。结果ELISA初筛有阳性反应(S/CO值>1)的样本,WB确认阳性率为81.93%。初筛阳性且有1种ELISA试剂S/CO值>6的样本,WB确认阳性率为100%。两种快速试剂检测均为阳性反应的,WB确认阳性率为100%。结论可以用两次ELISA、两种快速试剂或一种快速试剂加一种ELISA试剂联合检测替代WB。     

试剂盒平衡时间对抗-HCV检测结果的影响因素分析

目的：探讨ELISA试剂盒平衡时间对抗-HCV检测结果的影响;研究抗-HCV灰区献血者再次献血的可行性和必要性。方法：变化试剂盒平衡时间,测定不同平衡时间的S/Co值。对部分灰区标本进行重组免疫印迹试验（RIBA）;应用荧光定量-聚合酶链反应（FQ-PCR）检测灰区标本HCVRNA;应用速率法检测灰区和抗-HCV阴性血清ALT。结果：ELISA试剂盒平衡时间在30min内,1NCU/ml抗-HCV质控、抗-HCV灰区标本的S/CO值随着平衡时间的延长而增加（P〈0.05）,但30min后变化不明显（P〉0.05）。32份灰区标本经Murex试剂筛选后的5份标本进行了RIBA检测,结果为2份可疑,3份阴性。FQ-PCR定量检测均为阴性;速率法ALT检测抗-HCV灰区和抗-HCV阴性标本结果分别为（19.20±7.38）U/L、（16.58±7.08）U/L。2者结果均〈40U/L,差异有统计学意义（t=1.48,P〉0.05）。结论：抗-HCV试剂盒在检测前应先在室温下平衡30min以上,否则会降低标本的S/Co值,影响结果判断;抗-HCV灰区标本ALT检测结果正常;抗-HCV灰区的献血者在核酸检测结果为阴性的前提下可考虑再次献血。     

ELISA、胶体硒和免疫试鸭验检测HIV抗体结果分析

目的 复检和确认初筛HIV抗体阳性血清，并对比分析试验结果。方法 对初筛阳性血清，用胶体硒和ELISA试验复检，任一复检试验阳性的血清再用westernblot（WB）试验确认。结果 224份初筛阳性血清经复检84份阳性，WB确认61份HIV—1抗体阳性，不确定10份，阴性13份。以WB结果为标准，ELISA、胶体硒法的阳性符合率分别为84．72％和82．43％。ELISA的敏感性为100％，特异性为96．84％，胶体硒法的敏感性为100％，特异性为95．03％。阳性、不确定和阴性组血清EI，ISA平均S／CO分别为20．550，2．244和1．434。ELISA和胶体硒法复检同时阳性，在阳性组、不确定组、阴性组分别为100％（61／61），10％（1／10）和0（0／13）。结论 胶体硒和ELISA复检可排除大部分初筛假阳性，但两种复检试验均存在一定的假阳性。3种试验的不符情况仅出现在HIV抗体阴性和不确定组，确定HIV感染依赖于WB确认试验。     

A sensitive and practical bioassay for thyrotropin using cultured FRTL-5 cells: assessment of bioactivity for serum TSH in patients with chronic renal failure

A sensitive bioassay for TSH employing a practical extraction method was developed, and the bioactivities in patients with chronic renal failure receiving hemodialysis were compared with those in normal subjects. Serum samples were obtained from 12 normal subjects and 12 patients with chronic renal failure receiving hemodialysis. TSH was extracted from the serum using anti-human TSH monoclonal antibody coated tubes, followed by elution with 2.0 mol/l guanidine-HC1 solution (pH 3.2). After the eluate had been dialyzed against phosphate buffered saline (pH 7.4) and again against TRIS-HC1 solution (pH 7.4) and then lyophilized, it was reconstituted with hypotonic Hanks' solution. Bioassay for TSH was performed by measuring the levels of cAMP released into the medium from cultured FRTL-5 cells incubated with the extract. The mean immunoreactive recovery rates of TSH from the serum in normal subjects and patients with chronic renal failure were about 42% (+/- 6) and 40% (+/- 2), respectively. The present bioassay was sufficiently sensitive to detect a serum TSH level of 1.0 mU/l when 3.0 ml of serum was used. Extracts from standard sera at concentrations ranging from 1.0 to 10 mU/l added to the culture medium caused significant linear increases in cAMP production. Based on analysis of covariance the regression line between the immunoreactivities and bioactivities of serum TSH in patients with chronic renal failure (y = 0.90x + 0.3, r = 0.92) was not significantly different from that in normal subjects (y = 1.04x + 0.1, r = 0.93).(ABSTRACT TRUNCATED AT 250 WORDS)     

间接法和夹心法HCV抗体诊断试剂盒的诊断性能评价与选择

目的对国产双抗原夹心酶联免疫法和间接酶联免疫法丙型肝炎抗原检测试剂进行诊断性能评价与选择。方法选择1种夹心法和3种间接法国产检测试剂,同时对60份血清盘标本和40份血液筛查标本进行检测,血液筛查标本的检测结果为阳性或灰区,并经确认试验确认。试剂间比较采用配对卡方检验;对假阴性率进行R×C列联表检验。结果 3种间接法试剂和夹心法试剂的灵敏度分别为90.2%、78.0%、95.1%和97.6%;特异度分别为78.1%、72.6%、94.1%和100%。夹心法的分析灵敏度比间接法高4~8倍,不同试剂及试剂组合的R×C列联表检验结果:χ2=29.898,P0.05。结论夹心法试剂诊断特性优于间接法试剂,夹心法与间接法试剂搭配,可明显降低假阴性率,有效防止漏检。     

Comparative evaluation of two newly developed devices for capillary viscometry

Viscometry is an often applied method in clinical chemistry. A variety of studies demonstrate an association of parameters related to blood viscosity with human pathology of varying origin. Whole blood and plasma viscosity are considered to be clinically useful indicators in the diagnostic workup and therapy monitoring of certain diseases. In this study, we compare the "Waegeviskosimeter" (WV) described in previous publications with a newly developed device, the "Reverse Flow Viscometer" (RFV). Both viscometers are capillary flow viscometers. Both overcome the disadvantage of common viscometers of the Ubbelohde and Cannon-Fenske type which require large amounts of plasma and which can be only applied to Newtonian fluids. The accuracy of the measurements of both viscometers, requiring less than 1.0 ml sample volume, is superior to most conventional methods. The major distinction in the functionality of the WV and the RFV is that the WV measures the kinematic viscosity whereas the RFV directly estimates dynamic viscosity without the requirement of additional density measurement. We found good reproducibility of viscosity with coefficient of variation CV < or =1.1% for both viscometers. Quality assurance measures have been carried out. Because no quality assurance scheme according to the guidelines proposed by the German Medical Association exists for plasma or whole blood viscosity, we tested reference material Lyphochek Unassayed Chemistry Control Level 1 and Level 2 (Bio-Rad Laboratories). We determined the viscosities 1.40 mPa s and 1.08 mPa s (37 degrees C) and the between-run precision from daily quality control runs with CV of 1.4% and 1.2% for the WV, and 1.7% and 1.4% for the RFV. For direct comparison reasons, we determined the viscosity in seventy human plasma and serum samples by both methods. Using the regression analysis described by Passing-Bablok, the RFV and the WV methods are highly correlated and show only little variations (r = 0.990, tau = 0.896). The regression equation is y(WV) = 1.035x(RFV) - 0.056 with a mean deviation of 0.4+/-3.6%. We conclude that both new devices for viscosity assessment fulfill all quality requirements as prescribed for clinical chemical laboratories. One advantage RFV is to measure the dynamic viscosity directly.     

用HIV抗原/抗体联合试剂筛查吸毒者中窗口期HIV感染者

目的筛查窗口期艾滋病病毒(HIV)感染者,并验证HIV抗原/抗体联合试剂(第四代试剂)的检测性能。方法用HIV抗原/抗体联合试剂对经HIV抗体筛查呈阴性反应的吸毒者样本进行检测,并与HIV抗原检测及HIV-1 RNA检测的结果作比较,以证实其为窗口期感染样本。结果1 934份HIV抗体阴性样本中发现3例窗口期HIV感染者;所用第四代试剂检出窗口期样本的敏感性为100%,特异性为99.28%,假阳性率为0.77%。结论用第四代试剂检测虽然可以在某种程度上缩短检测窗口期,但该试剂有一定的假阳性结果,尤其是在S/CO值较低时其假阳性比率增高,故检测时应注意S/CO值的高低,如有条件可进一步做HIV-1 RNA检测。     

Epidemiology and immunodiagnostics of Strongyloides stercoralis infections among migrant workers in Malaysia

Objective: To investigate the status of Strongyloides(S.) stercoralis infections among migrant workers in Malaysia for the first time and identify risk factors.Methods: Four diagnostic methods were employed for the detection of S. stercoralis including microscopy, enzyme-linked immunosorbent assay(ELISA) using a commercial kit, ELISA using the rSs1a antigen and polymerase chain reaction(PCR). Low and semi-skilled workers from five working sectors(i.e. manufacturing, food service, agriculture and plantation, construction and domestic service) were tested on a voluntary basis. Results: The overall seroprevalence of S. stercoralis from 483 workers employing the ELISA commercial kit for IgG was 35.8%(n=173; 95% CI: 31.5%-40.1%) whereas seroprevalence using the rSs1a-ELISA was 13.0%(n=63; 95% CI: 10.0%-16.0%). Cross tabulation between the ELISA commercial kit and rSs1a-ELISA showed that only 6.4%(n=31; 95% CI: 4.2%-8.6%) of the samples were positive in both tests. Microscopic examination of all 388 fecal samples were negative; however subsequent testing by a nested PCR against DNA from the same samples successfully amplified DNA from three male subjects(0.8%; 3/388). Male workers, India and Myanmar nationality, food service occupation and those living in the hostel were statistically significant with seroprevalence(P0.005). Conclusion: This is the first report on the epidemiology of S. stercoralis infections among the migrant workers in Malaysia. Our results highlight the importance of using appropriate diagnostic tools for detection. The presence of anti-S. stercoralis antibodies in the study population calls for improvements in personal hygiene and sanitation standards among migrant workers in Malaysia through control strategies including health education campaigns and programs aimed at increasing awareness and healthy behaviors.     

丙型肝炎核心抗原检测在丙型肝炎诊断中的意义

目的了解丙型肝炎核心抗原（HCV-cAg）检测方法的敏感性及特异性,确定具有临床意义的S/CO值,探讨其在丙型肝炎诊断中的意义。方法使用ELASA方法检测丙型肝炎核心抗原,RT-PCR检测HCV RNA定量,观察不同S/CO值所对应的HCV RNA定量之间的关系,以HCV RNA为诊断金标准,列四格表做诊断实验。结果 HCV-cAg抗原检测的敏感性为87.05%,特异性为76.67%,阳性预测值为96.53%,阴性预测值为44.23%。结论 （1）随着HCV-cAg的S/CO值逐渐增大,其与HCV RNA阳性符合率明显增高,随着HCV-cAg的S/CO值减小,其与HCV RNA阴性符合率明显增高;（2）S/CO值=2可以作为临床判断HCV感染病毒血症存在的一个标准;（3）本实验的敏感性和特异性较好,检测方法简单,可以作为丙型肝炎临床诊断的补充试验及筛查。