丙型肝炎病毒核心抗原检测试剂的临床评价

[目的]对研制的丙型肝炎病毒核心抗原（HCV—cAg）ELISA检测试剂进行临床特异性及敏感性评价。[方法]制备抗HCV-核心区（Core）抗原四株单克隆抗体，研制出双抗体夹心检测HCV～core抗原酶联免疫检测（ELISA）试剂。三家临床单位收集抗HCV阴性样品3040份，HBsAg阳性100份，抗HIV阳性40份，从10万份抗-HCV筛查出临界样品28人份。[结果]3040份阴性样品检测有3份HCV—cAg阳性，3份经HCVPCR检测有1份阳性，100份HBsAg阳性，40份抗HIV阳性样本检测均为阴性，在10万份抗HCV抗体筛查样品中，选择28份抗-HCV检测临界样品进行HCV—cAg检测，有4份阳性，4份HCV—cAg阳性样品中有3份HCV—RNA检测阳性。[结论]研制的双抗体夹心HCV-核心抗原ELISA试剂具有很好的特异性和灵敏度。     

丙型肝炎病毒核心抗原检测试剂盒的临床应用评价

目的采用酶联免疫吸附试验（ELISA）检测丙型肝炎病毒核心抗原（HCVcAg）。方法对苏州市吴中人民医院2011年2月至2012年2月的2 523份输血、手术前住院患者血清标本进行抗-HCV初、复检检测。将初、复检均阳性的其中10份、仅初检阳性的15份和仅复检阳性的17份血清标本分别采用ELISA检测HCVcAg和采用RT聚合酶链反应（RT-PCR）检测HCV。结果 ELISA检测HCVcAg阳性结果为4份（40%）。32份仅初检或复检抗-HCV阳性标本采用ELISA检测HCVcAg阳性6份,阳性率为18.75%。采用RT-PCR荧光定量检测HCV 10份初、复检抗-HCV均阳性的血清标本结果均为阳性,32份仅初检或复检抗-HCV阳性标本采用RT-PCR荧光定量检测HCV阳性5份,阳性率为15.63%。结论 HCVcAg的敏感性与RT-PCR荧光定量检测HCV类似,能对HCV的感染作出早期诊断。     

丙型肝炎病毒核心抗原检测技术的应用评价

目的 探讨丙型肝炎病毒核心抗原(HCV-cAg)检测技术筛查丙型肝炎的应用价值.方法 对门诊体检人群、无偿献血人群进行HCV抗体初检、复检,筛选HCV阳性血清标本、HCV可疑血清标本检测HCV-cAg;同时对单项丙氨酸氨基转移酶(ALT)增高的标本和血液筛查合格的标本进行HCV-cAg的检测.对HCV-cAg阳性标本进...     

丙型肝炎病毒不同编码区重组抗原在抗体检测中的应用

目的　探讨丙型肝炎病毒 (HCV)不同编码区重组蛋白片段的免疫反应性及其在抗体检测中的应用。方法　分别以 4种HCV单片段抗原 (C、NS3、NS4或NS5 )检测抗 HCV抗体阳性血清 ;以 4种单片段抗原的混合物 (MIX)检测抗 HCV抗体阳性血清、大学生体检血清和抗 HCV抗体阴性质控血清。结果　 90份抗 HCV抗体阳性血清中共有 75份可与一种或多种单片段抗原反应 ,阳性率分别为 70 .0 % (C)、6 1.1% (NS3)、5 2 .2 % (NS4 )、4 4 .4 % (NS5 ) ,其中仅与C、NS3、NS4和NS5一种抗原发生反应的分别有 8份、1份、2份和 3份血清标本 ;90份抗 HCV阳性血清经MIX抗原检测 ,阳性率为 83.3% (75 / 90 ) ;10 0份大学生血清和39份阴性质控血清经混合抗原检测均阴性。结论　HCV不同编码区重组蛋白片段有不同的免疫反应性 ,在发展抗 HCV抗体诊断试剂时 ,应采用各种不同编码区的混合抗原。     

ELISA检测丙型肝炎病毒核心抗原的临床应用价值

【目的】探讨丙型肝炎病毒（HCV）核心抗原酶联免疫吸附试验（ELISA）检测方法的临床应用价值。【方法】采用HCV核心抗原ELISA试剂盒,对32例HCVRNA基因扩增试验检测为阳性的临床丙肝感染者血清进行检测,同时用抗-HCVELISA检测试剂盒作为对照进行比较。【结果】与HCVRNA PCR检测为对照,HCV抗原检测试剂盒的灵敏度为96．9％,特异性为96．7％。32例HCVRNAPCR检测阳性血清,用抗-HCV检测法进行检测,其中有5例阴性,将这5例阴性标本用HCV核心抗原检测法进行检测,其中4例为阳性。【结论】丙型肝炎核心抗原ELISA检测方法能缩短窗口期、敏感性高、特异性好、费用低廉,在临床上具有很好的推广前景。     

在安全输血中应用丙型肝炎病毒核心抗原检测技术的初步探索

本研究探讨用丙型肝炎病毒（HCV）核心抗原酶联免疫吸附技术（HCV-cAg ELISA）筛查献血员感染HCV的可行性.对我医院2003年1月-2005年12月间的8 677份献血者血清标本进行抗-HCV初检和复检.将仅初检阳性的15份血清标本和仅复检阳性的14份血清标本,分别再做HCV-cAg ELISA和HCV RT-PCR检测.结果表明：经HCV-cAg ELISA检测,29份仅初检（15份）和仅复检（14份）抗-HCV阳性血清标本中只有5份结果为阳性,阳性率为17.24%.经HCV RT-PCR检测,29份仅初检和仅复检抗-HCV阳性血清标本中同样也只有5份阳性结果,阳性率也为17.24%.结论：HCV-cAgELISA检测技术的敏感性与HCVRT-PCR技术类似,但成本明显降低,有可能作为HCV感染的辅助确证试验,或作为抗-HCV检测技术的更新换代技术用于安全输血中献血者血液的筛查.     

丙型肝炎病毒游离抗原与抗体酶联免疫法检测相关性及临床意义

目的 运用ELISA法分别检测HCV-Ag和HCV-Ab,并进行比较分析,探讨两者之间相关性及临床意义.方法 检测本院来自血液透析室及门诊住院的300例丙型肝炎肝病患者血清.同时设阴性、阳性对照.结果 HCV-Ag阳性20例,HCV-Ab阳性260例,两者均阳性10例,两者均阴性10例.结论 HCV-Ag、HCV-Ab...     

丙肝病毒核心抗原试剂检测进展

丙肝病毒(HCV)核心抗原是HCV结构蛋白之一，其血清中的滴度和HCV RNA水平密切相关。目前使用的HCV抗体诊断试剂和核酸检测技术存在诸多问题。随着HCV核心抗原检测系统的不断完善，该系统将有可能取代抗体和核酸检测，成为筛选献血者HCV的检测项目。     

丙型肝炎病毒核心抗原检测的临床应用价值

目的探讨丙型肝炎病毒核心抗原（HCV—cAg）酶联免疫吸附试验（ELISA）检测方法的临床应用价值。方法对20例HCV抗体（HCV—Ab）阳性标本和200例HCV—Ab阴性标本进行HCV—cAg测定,同时采用核酸扩增进行HCV—RNA对照测定。结果20例HCV—Ab检测阳性的标本中HCV—cAg阳性8例,200例HCV—Ab检测阴性的标本中HCV．cAg阳性3例;以HCV—RNA聚合酶链反应（PCR）检测为对照,HCV—cAg检测试剂盒的敏感性为88．3％,特异性为99．5％。结论HCV—cAgELISA检测方法敏感性和特异性较好,HCV—Ab和HCV—cAg联合检测可起到互补作用,提高阳性检出率,有利于早期诊断。     

HCV核心抗原检测在血液筛查中的初步研究

目的 探讨丙型肝炎病毒核心抗原(HCV cAg)醇免检测试剂用于血液筛查的应用价值.方法 同时用抗HCV抗体和HCV cAg酶免检测试剂平行筛查血液,对HCV抗体阴性样本用Chiron Procleixa TMA系统检测HCV RNA.结果 1 762份无偿献血者样本中,抗HCV阳性12份(0.68％),HCV cAg阳性10份(0.57％),阳性检出率差异无统计学显著性意义(P＞0.05),抗HCV及HCV cAg同时阳性4份(0.23％).1 750份抗HCV阴性样本中,其中HCV cAg阳性样本6份,HCV RNA全为阴性.结论 在血液筛查中增加HCV cAg检测,对降低HCV的输血传播危险具有一定价值.     

丙型肝炎病毒核心抗原检测在丙型肝炎筛检中的应用

目的探讨丙型肝炎病毒核心抗原(HCV-cAg)对丙型肝炎(简称丙肝)筛查的意义。方法收集2014年10月至2015年10月8 000例门诊及住院患者,用酶联免疫吸附试验(ELISA)检测HCV-cAg、丙型肝炎病毒抗体(HCV-Ab),并对HCVcAg或HCV-Ab阳性标本采用聚合酶链反应(PCR)法检测HCV-RNA进行确诊。结果以HCV-cAg或HCV-Ab阳性为标准,从8 000例血清样本中初步筛查出阳性样本82例,经HCV-RNA确证,其中HCV-RNA阳性73例,阴性9例,HCV-cAg的灵敏度及特异度分别为45.83%和99.98%,HCV-Ab的灵敏度及特异度分别为94.44%和99.90%,联合检测HCV-cAg与HCV-Ab的灵敏度及特异度分别为100.00%和99.86%。结论在丙肝筛检工作中,HCV-cAg与HCV-Ab二者有互补性,联合检测HCV-cAg与HCV-Ab有助于提高HCV筛查率。     

丙型肝炎核心抗原与丙型肝炎抗体联合检测在丙型肝炎诊疗中的作用

目的了解丙型肝炎核心抗原(HCV-cAg)检测在丙型肝炎(简称丙肝)诊疗中的作用。方法采用酶联免疫吸附试验(ELISA)对400例健康体检者和600例邢台市人民医院住院患者进行HCV-cAg和丙肝抗体(抗-HCV)联合检测,HCV-cAg阳性标本用PCR荧光定量法检测HCV-RNA确认。结果 400例健康体检者6例(1.5%)抗-HCV阳性,0例HCV-cAg阳性;600例住院患者12例(2%)抗-HCV阳性,4例(0.67%)HCV-cAg阳性(含1例抗-HCV阳性),HCV-RNA确认3例,二者符合率为75%。结论 HCV-cAg较抗-HCV的检测将丙肝病毒感染的"窗口期"提前了,是HCV的早期诊断指标,HCV-cAg与抗-HCV联合检测有助于提高HCV的诊断率,对于HCV筛查有重要意义,是有效防范丙肝传播的重要手段,值得推广。     

Utility of a commercial quantitative hepatitis C virus core antigen assay in a diagnostic laboratory setting

In this study, the utility and impact of hepatitis C virus (HCV) core antigen (Cag) detection via a commercial assay have been evaluated in diagnostic laboratory conditions. In a total of 272 samples from 226 individuals, HCV RNA was detected in 81.3% and anti-HCV antibody prevalence was 86.4%. HCV Cag reactivity was identified in 59.9% of the samples and in 75.8% with detectable RNA. The sensitivity and specificity of HCV Cag assay have been calculated as 75.8% and 95.1%, respectively, and agreement between HCV RNA and HCV Cag was moderate (κ = 0.554). HCV Cag and RNA levels were highly correlated (r = 0.915 and 0.937). A viral load threshold of 10³ IU/mL has been recognized, above which the correlation with RNA became statistically significant and sensitivity increased to 90.9%. Detection and quantification of HCV core antigen have been observed as a strong alternative to nucleic acid testing for HCV monitorization.     

Detection of hepatitis C core antigen in serum or plasma as a marker of hepatitis C viraemia in the serological window-phase

A new immunoassay for the detection of hepatitis C core antigen (HCVcoreAg) in peripheral blood during serological window-phase was evaluated among healthy blood donors, commercially available hepatitis C virus (HCV) seroconversion panels and in-house specimens from individuals undergoing seroconversion. Among 1964 low-risk blood donor samples, seven samples were initially reactive but only one was repeat reactive. Reactivity of this specimen was not confirmable by neutralization with specific anti-HCV core antibody, and the sample was negative for HCV RNA by polymerase chain reaction (PCR). The specificity of the HCVcoreAg enzyme-linked immunosorbent assay (ELISA) was 99.95%. In seven commercially available HCV seroconversion panels, HCVcoreAg appeared 23-46 days earlier than anti-HCV antibody by third generation assay. Additional testing with specimens from patients undergoing anti-HCV seroconversion indicated that HCVcoreAg becomes undetectable by the present test format soon after the onset of antibody. This test may be considered as an alternative to nucleic amplification techniques (NAT) for blood donor HCV screening. Additional development of technology for detecting HCVcoreAg may be useful for patient diagnosis and therapy monitoring.     

Application of a new enzyme-linked immunosorbent assay for detection of total hepatitis C virus core antigen in blood donors

Recent studies have shown that total hepatitis C virus (HCV) core antigen, both free and antibody bound, is an accurate indirect marker of viral replication that can be used in clinical practice. The aim of the present study was to evaluate the performance of a new total HCV core antigen enzyme-linked immunosorbent assay (ELISA) for detection and quantification of total core antigen in blood donors, testing positive for anti-HCV antibodies and for prospective low-risk population screening. A population comprising 257 samples, from blood donors detected reactive for anti-HCV antibodies [137 recombinant immunoblot assay (RIBA) positive and 120 RIBA indeterminate], were tested by using a new total HCV core antigen ELISA. HCV-RNA was quantified by using quantitative polymerase chain reaction (PCR) assays in all RIBA-positive samples and RIBA-indeterminate samples that were positive for the total core antigen. Specificity of the assay was studied in 1070 healthy blood donors negative for anti-HCV antibodies. Compared with quantitative PCR assays, the total HCV core antigen assay showed 97.37% sensitivity. The three HCV-RNA-positive samples, which tested negative for the total core antigen, had a low viral load (< 1.4 x 10(4) IU mL(-1)). All samples with more than 1.4 x 10(4) IU mL(-1) of viral RNA were positive for total core antigen, independent of the HCV genotype. Concentration of total core antigen correlated significantly with those of HCV-RNA (r = 0.614, P < 0.0001). Overall specificity in freshly collected blood donor specimens was 99.63%. Our data indicate that the total HCV core antigen ELISA has a sensitivity close to PCR assays in diagnosing HCV infection in blood donors with anti-HCV antibodies and shows an excellent specificity in volunteer donors. This assay, in combination with anti-HCV antibodies screening tests, could be an alternative to molecular assays for HCV infection screening in blood donors.     

Role of Hepatitis C Virus (HCV) core antigen in improving blood transfusion safety in high prevalence,resource limited countries,a step forward

Objective

The aim of the present study was to evaluate the efficacy of hepatitis C virus [HCV] core Ag as an alternative affordable test in resource limited countries blood banks.

HCV感染者/慢性丙型肝炎患者血清HCVRNA含量、外周血淋巴细胞Fas抗原及ALT浓度的相关性

目的探讨HCV感染者/慢性丙型肝炎患者血清HCV-RNA含量、外周血淋巴细胞(PBL)Fas抗原及ALT浓度的相关性。方法对本站献血群中60例HCV感染者,50例正常者及来自本市一院56例慢性丙型肝炎患者,采用荧光定量PCR检测其HCV-RNA含量,用FACSCalibur流式细胞仪为检测外周血淋巴细胞Fas抗原,用生化自动分析仪检测ALT浓度。结果本研究116例HCV感染者/慢性丙型肝炎患者血清HCV-RNA含量与PBLFas抗原表达率、ALT异常率呈正相关(γ值分别为0.94、0.96,均P﹤0.01),但与ALT浓度无相关性γ=0.38,0.03,无统计学意义(P均>0.05),ALT浓度差异无统计学意义(均P>0.05),ALT异常率差异有统计学意义(P﹤0.05)。结论HCV感染者/慢性丙型肝炎患者血清HCV-RNA含量与外周血淋巴细胞Fas抗原呈正相关、与ALT异常率相关性显著,外周血淋巴细胞Fas抗原与ALT异常率相关性显著。     

乙型肝炎病毒X抗原、X抗体检测的临床意义

目的了解乙型肝炎病毒X抗原(HBxAg)、X抗体(HBxAb)在乙型肝炎、肝硬化、肝癌患者血清中的表达情况,探讨HBxAg和HBxAb与上述疾病的相关性和临床意义。方法应用大肠埃希菌合成重组HBxAg,用该抗原免疫动物获得的HBxAb分别包被反应板以酶联免疫吸附试验(ELISA)检测患者(171例乙型肝炎、70例肝硬化和38例肝癌)血清中HBxAg和HBxAb。结果在乙型肝炎、肝硬化、肝癌患者血清中HBxAg和HBxAb阳性率分别为8.8%、18.6%、7.9%和10.5%、47.1%、34.2%,HBxAg在肝硬化患者中检出率较高(P<0.025);与乙型肝炎组比较,HBxAb阳性率在肝硬化和肝癌患者均有显著增高(P<0.005)。结论HBxAg在肝硬化患者检出率较高,而HBxAb则在乙型肝炎后的肝硬化和肝癌患者检出率较高,提示HBxAg和HBxAb可能参与肝组织的免疫病理性损伤过程。