国内丙型肝炎病毒抗体酶联免疫法试剂评价参考品体系的建立

目的 建立国内丙型肝炎病毒抗体酶联免疫法(EIA)诊断试剂评价参考品.方法 收集2009-03/2010-10期间来自全国不同省份4833份供血人员血清样品,用国产5种抗HCV EIA试剂和国外2种抗HCV EIA试剂分别进行初筛和复检;用Chiron的RIBA HCV 3.0 SIA、Roche HCV定量试剂对筛选样品进行了确认试验,对确认阳性样品进行HCV基因型检测;选择不同强度的确认阳性、阴性样品、混合阳性系列稀释样品、部分特殊样品等建立抗HCV诊断试剂评价参考品.结果 设立了抗HCV诊断试剂评价参考品,包含30份强、中、弱阳性的抗HCV混合阳性样品,10份单片段抗体阳性确认阳性样品,6份评价灵敏度系列稀释样品,30份抗HCV确认阴性样品.结论 本研究设立的抗HCV评价参考品检测结果可靠,样品涵盖背景丰富,对新产品研发和筛选评价高质量的抗HCV诊断试剂有一定参考价值.     

基因芯片在丙型肝炎病毒分型检测中的评价

为研究HCV基因分型芯片检测丙型肝炎患者的基因型,以测序法进行对比,并探讨了IFN治疗慢性丙肝疗效与基因型的关系。采用基因芯片的方法对20例慢性丙型肝炎患者进行分型,并通过测序验证。结果基因芯片和测序结果完全一致。20例丙肝患者中18例为1b,2例为2a,并且IFN治疗效果2a较1b型为优。HCV分型芯片检测HCV分型,特异性强、灵敏度高、结果准确,支持HCVRNA基因型在评价IFN疗效中十分重要的观点。     

丙型肝炎病毒基因型的研究进展

丙型肝炎是一种主要经血液传播的疾病,丙型肝炎病毒慢性感染可导致肝脏慢性炎症坏死和纤维化,部分患者可能发展成为肝硬化或肝癌。HCV是单股RNA病毒易变异,目前可分为6个基因型与不同的亚型,本文就此问题的研究状况进行综述。     

丙型肝炎病毒与安全血液

丙型肝炎在全世界广泛流行，并且有不少地区还表现出上升的趋势，严重程度及其复杂性日益突出，使采供血工作以及输血安全面临许多问题，所以本文重点就丙型肝炎病毒与安全血液的若干问题作一综述。     

不同化学发光分析系统检测丙型肝炎病毒抗体的性能评价

目的 评价罗氏Cobas e601及雅培Architect i2000两种化学发光免疫分析系统检测抗-HCV的分析性能和一致性.方法 按照CLSI推荐的方法对两台分析仪检测抗-HCV的精密度、检出限、阴阳性符合率等性能进行验证试验;两台仪器分别检测120例有反应性血清样本及30例无反应性样本,用Kappa检验评价检测结果的一致性.结果 两台仪器的精密度良好;检出限均为0.3NCU;阴阳性符合率为100％;两个分析系统检测抗-HCV总体符合率为70.67％,无反应性、e601 S/CO≥15.0、i2000 S/CO≥6.0样本结果的符合率为100％,e601 S/CO为1.01 ～5.0和i2000 S/CO为1.01 ～2.0样本结果的符合率为0和44.4％:经统计分析κ=0.35在Kappa系数区段中一致性程度属于弱(κ=0.35,P＜0.05).结论 两个分析系统检测抗-HCV的分析性能均良好,适用于临床标本的常规检测,对于两台仪器检测结果不一致的样本,尤其是e601 S/CO 1 ～ 15及i2000 S/CO 1～6的样本,建议进行补充实验(RIBA,NAT)来明确诊断.     

丙型肝炎病毒血清学分型应用的可行性研究

目的 探讨丙型肝炎病毒血清学分型的可行性。方法 应用EIA法对兰州地区148例抗－HCV阳性者进行血清学分型。结果 血清学方法的分型率为56．08％（83／148）,其中血清1型占50．60％（42／83）,血清2型占43．47％（36／83）,1＋2混合型占6．03％（5／83）。对其中70例HCVRNA阳性血清的基因型与血清型结果进行比较,二者完全相符。结论 丙型肝炎病毒的血清学分型具有一定的临床应用价值。     

丙型肝炎病毒基因结构与实验室检测技术

丙型肝炎是一种血源性病毒病.发病率高,病期长,可引发慢性肝炎、肝硬化和肝细胞癌,对人类健康构成重大威协.HCV容易变异,型别和亚型多.随着对病毒病防控力量加强,丙型肝炎的危害性日益显露出来,应引起社会广泛关注,呼吁主管部门对疫苗研制增加投入.加速诊断试剂标准化,探索新的献血员筛查模式,制订完善献血员筛选程序,阻断病毒经血传播.寻找有效价廉的抗病毒药物,提高治愈率.聚乙二醇干扰素应作为目前治疗丙型肝炎首选药物.树突状细胞是一种很有前途的治疗性疫苗.疫苗的研究已显露出可喜的端倪,人们热切期待疫苗问世.丙型肝炎疫情没有得到有效控制,还有那么多病人在等待治疗.防治检三管齐下,将丙型肝炎危害降至最低,任重而道远.     

献血员中抗丙型肝炎病毒抗体调查

献血员中抗丙型肝炎病毒抗体调查王毅，胡艳敏，胡艳丽，王春山，贾君凡，薛浩，杨安峰，王云峰，姜艳丽（河南禹州市卫生防疫站，禹州４５２５７０）丙型肝炎在１９８９年正式定名以来，国内外ＨＣＶ感染的诊断主要依靠抗－ＨＣＶ的检测。随着河北省固安县因器械消毒不严...     

Evaluation of commercially available third-generation anti-hepatitis C virus enzyme-linked immunosorbent assay in patients on haemodialysis

Restricted antibody reactivity to hepatitis C virus (HCV) synthetic peptides has been observed in HCV-infected patients on haemodialysis (HD). The aim of this study was to evaluate third-generation anti-HCV enzyme-linked immunosorbent assay (ELISA) test systems containing either synthetic peptide HCV antigens or recombinant HCV antigens or a combination of synthetic and recombinant antigens in screening of 69 chronic renal failure patients on HD for HCV infection. Seven patients were detected to have antibodies to HCV by the 'recombinant HCV antigens'-containing kits, of which the recombinant immunoblot assay for HCV confirmed four cases. The recombinant kits had a sensitivity of 100% and a specificity of 66%. However, the ELISA kits with only synthetic HCV antigens failed to detect antibodies in any of the cases (zero sensitivity). Hence a recombinant protein containing ELISA test system is ideal for screening of HCV infection in patients on hemodialysis.     

丙型肝炎病毒(HCV)荧光PCR(F-PCR)试剂盒的研制及与免疫学方法的比较

目的：用荧光PCR（Fluorescence PCR,F-PCR）方法研制丙型肝炎病毒（Hepatitis C Virus,HCV)RNA检测试剂盒，通过临床验,春性能，并与免疫学方法比较。方法：F－PCR是PCR和荧光探针杂交技术结合所产生的PCR方法。由于采用完全闭管荧光检测，避免了PCR后处理导致的假阳性污染；又采用了荧光检测技术，可以提高检测的灵敏度。结果：设计合成了HCV F－PCR诊断试剂盒。检测了512份临床血清标本，以美国Abbott公司的HCV ELISA诊断试剂盒和美国Biotronics公司的HCV荧光RT－PCR诊断诊断试剂盒（B－PCR）为对照。阳性率30.5%，灵敏度97.3%，特异性98.1%。结论：F－PC的灵敏度显著优于ELISA，也高于B－PCR；三者的特异性无统计学差异。F－PCR试剂盒可以检测HCV的真实感染情况，对于临床诊断和疗效考察有一定的指导意义。     

四种乙肝病毒表面抗原ELISA诊断试剂的评价

目的 对四种国内乙肝病毒表面抗原诊断试剂进行评价。方法 用四种试剂分别对标准品和未知血清进行检测，用几种常用诊断试验评价方法对检测结果进行分析和比较。结果 四种试剂对标准血清的检测结果较好，A、B两种试剂的总符合率为100％，另两种的总符合率也在90％以上，其中B试剂有较好的精密性。δ值比较显示A和B两种试剂有较好的诊断特性。四种试剂在一定的抗原浓度范围内都有良好的线性关系。针对于未知样本的检测中，四种试剂与采用电发光法的罗氏诊断试剂有较好的一致性。结论 国内主要厂家的HBsAg ELISA诊断试剂具有较高的检测效能。在实际工作中，可以通过常用的诊断试剂筛选实验，经统计分析后筛选出较高效能诊断试剂用于检测。     

Double-antigen sandwich ELISA for the detection of anti-hepatitis C virus antibodies

A double-antigen sandwich ELISA was developed a detection of HCV antibodies by a recombinant multi-epitope HCV antigen and a biotin-streptavidin amplification system. Three plasma specimens from 1708 individuals who were suspected previously to be HCV-positive using an HCV antibody diagnostic kit (Chuangxin, Xiamen, China) displayed negative results when using the ELISA. These results were validated by a recombinant immunoblotting assay (two were negative, and one was indeterminate). Among 889 blood specimens donated for clinical evaluation, 246 were positive and 630 were negative using the ELISA. The sensitivity and specificity of the ELISA were 98.7% and 100%, respectively. In 43 donors and 14 patients with chronic hepatitis C, the detectable rates for HCV IgM by both ELISA and the HCV anti-IgM detection reagents (Huimin, Shenyang, China) were 100%, and the detectable rate for HCV IgG using an indirect HCV-antibody detection kit (GWK, Beijing, China) was 98.3%. Thus, the double-antigen sandwich ELISA exhibits strong specificity and sensitivity and has been approved by the China State Food and Drug Administration (SFDA). The performance of the double-antigen sandwich ELISA was similar to the Ortho ELISA 3.0. It did not give false-negative results otherwise IgM was undetectable using an indirect HCV-antibody detection kit. This ELISA provides another method for the detection of HCV antibodies.     

胶体金联免疫吸附试验检测丙型肝炎病毒抗体

采用基因工程方法，用在大肠杆菌中表达的丙型肝炎病毒（ＨＣＶ）－Ｃｏｒｅ和ＮＳ３优势表位抗原，建立了检测ＨＣＶ－ＩｇＧ抗体的间接胶体金联免疫吸附试验。其特异性、敏感性均达到国内外ＥＬＩＳＡ试剂盒水平，其特点是操作简便，观察结果直观可靠，适于医院、血站和家庭自检。     

Evaluation of immunoglobulin M and G capture enzyme-linked immunosorbent assay Panbio kits for diagnostic dengue infections.

BACKGROUND: Serological assays are widely used to confirm dengue virus infections and to differentiate between a primary and a secondary infection. OBJECTIVE: Two commercial dengue diagnostic kits, Panbio Dengue IgM Capture and Dengue IgG Capture ELISA (Brisbane, Australia) were evaluated. STUDY DESIGN: Three hundred and seventy-three serum samples were tested. Panel sera included samples from dengue confirmed cases (representing both primary and secondary infections), from non-dengue infectious diseases, and from healthy individuals. The MAC-ELISA/Dengue IPK was used for the detection of anti-dengue virus IgM antibody in the sera and the ELISA inhibition method (EIM/Dengue IPK) was used to differentiate between primary and secondary infections. Both these reference assays, which were previously developed in the Arbovirus Laboratory at the "Pedro Kouri" Tropical Medicine Institute, were employed as the gold standard. RESULTS: High sensitivity (96.8%) and specificity (99.4%) were found with the commercial diagnostics when compared to the reference methods. Furthermore, high concordance 95.5% in classifying dengue infection types (primary or secondary infections) was observed. CONCLUSIONS: The Panbio Dengue IgM and IgG assays offer a good alternative for dengue diagnosis. They are easy to perform and results can be obtained in less than 3h.     

丙型肝炎患者血清抗丙型肝炎病毒抗体IgM及HCVRNA检测结果的比较

用酶联免疫吸附试验（ＥＬＩＳＡ）对住院病人抗丙型肝炎病毒抗体（抗－ＨＣＶ）阳性血清标本进行抗－ＨＣＶＩｇＭ的检测，并与ＨＣＶＲＮＡ检测结果比较。结果表明，ＨＣＶＲＮＡ阳性、抗－ＨＣＶ阳性，ＨＣＶＲＮＡ阳性、抗－ＨＣＶ阴性及ＨＣＶＲＮＡ阴性、抗－ＨＣＶ阳性三种类型中均有抗－ＨＣＶＩｇＭ阳性者。结果还表明ＨＣＶＲＮＡ阳性病例的抗－ＨＣＶＩｇＭ阳性率明显高于ＨＣＶＲＮＡ阴性的病例（Ｐ＜０．０５），在临床诊断上ＨＣＶＲＮＡ阳性与阴性病例的肝病大多数为急性肝炎（ＡＨ）和慢性活动性肝炎（ＣＡＨ），ＨＣＶＲＮＡ阳性与阴性比较，各类肝病的病例数无明显差别。     

Discordance between four second-generation enzyme immunoassay kits in anti-hepatitis C virus screening

Participating laboratories: Bordeaux (P. Trimoulet; L. Richard); Limoges (S. Ranger); Marseille (X. de Lamballerie); Paris VI (V. Fauveau; F. Lunel-Fabiani); Paris XI (Y. Lazizi); Poitiers (G. Agius); Rennes (A. Ruffault); Rouen (I. Mendel); Strasbourg (H.J. Wendling); Toulouse (J. Isopet); Tours (F. Barin).