丙型肝炎病毒核心抗原检测用于献血者筛查价值的探讨

目的应用酶联免疫吸附技术筛查献血员中丙型肝炎病毒核心抗原（HCV—cAg）和抗体（HCV—Ab），了解丙型肝炎病毒核心抗原筛查献血员应用价值。方法对我站2004年8-12月间的3972份献血者血清标本进行抗-HCV初、复检和HCV—cAg ELISA检测，将ELISA法阳性的25份血清标本，再做RT-PCR检测证实。结果3972份血清标本检测中，有10份仅初检抗-HCV阳性样本，经HCVRNA检测阳性有l份，12份仅复检抗-HCV阳性样本，经HCVRNA检测阳性有1份，HCV—cAg检测阳性有3份，经HCVRNA检测阳性有2份。结论HCV—cAg ELISA检测技术的敏感性与HCVRNA技术类似，但成本明显降低，可与HCV抗体联合检测应用献血员筛查。     

检测丙型肝炎病毒实验研究

目的探讨丙型肝炎患者血清丙型肝炎病毒抗体（抗-HCV）结果与丙型肝炎病毒核糖核酸（HCV—RNA）定量的相关性。方法采用酶联免疫吸咐实验（ELISA）和实时荧光定量PCR（FQ—PCR）技术,对621例同时做抗-HCV和HCV—RNA的丙型肝炎患者检测。结果621份标本中有115份HCV—RNA含量高于1000拷贝／ml,124份抗-HCV阳性。经统计分析,两者有明显的相关性。结论血清抗-HCV与血清HCV—RNA之间有较好的一致性;抗-HCV检测和HCV—RNA检测均有一定的局限性,同时检测抗-HCV和HCV-RNA可提高丙型肝炎患者的检出率．为其诊断和治疗提供帮助。     

实时荧光定量HCV RNA与ALT检测在丙肝筛查中临床价值的研究

目的 探讨抗-HCV抗体阳性时,实时荧光定量HCV RNA与ALT检测在丙肝筛查中临床价值的研究.方法 回顾选择2019年1月至2019年12月首都医科大学附属房山区良乡医院收治的患者109例为研究对象,均留取外周静脉血,测定血清抗-HCV抗体、HCV RNA,丙氨酸氨基转移酶(ALT)水平.结果 在收集的109例抗-HCV抗体阳性患者样本中,以HCV RNA为金标准作为丙型肝炎的诊断,HCV RNA阳性患者占20.2％(22/109),HCV RNA阴性患者占79.8％(87/109),两组样本经独立样本配对t检验,P值为0.006,差异有统计学意义(P<0.05),以HCV RNA检测为金标准,用SPSS 23.0软件对抗-HCV的S/CO值及ALT进行ROC曲线处理,HCV抗体S/CO值对丙型肝炎的ROC曲线下面积(AUC)为0.851,ALT对丙型肝炎的ROC曲线下面积(AUC)为0.831.结论 HCV RNA阳性患者ALT平均值明显高于HCV RNA阴性患者的ALT平均值.抗-HCV的S/CO值及ALT对于丙型肝炎的筛查都有一定的价值,且抗-HCV抗体优于ALT的筛查.临床上,患者筛查丙型肝炎抗体阳性时,可同时进行ALT的检测,可为丙型肝炎早期诊断提供依据,以免延误治疗时机.     

1年以上血透患者HCV感染状况的调查

目的 研究1年以上的长期血液透析患者丙型肝炎（HCV）感染状况。方法 用ELISA法和RT－PCR法检测137例长期血透患者血清中的抗－HCV和HCVRNA,并且同时检测谷丙转氨酶（ALT）和谷草转氨酶（AST）,计算其变动率。结果 透析时间超过1年以上的137例患者中仅抗－HCV阳性8例,仅HCV－RNA阳性13例,抗－HCV与HCVRNA同时阳性者24例,感染率34．3％。且透析时间小于2年的,HCV感染率为15％,透析时间大于2年以上的其感染率增至37．6％。结论 血透患者中HCV的感染应引起重视,透析的年限越长,被HCV感染的机率就越大。酶学指证的变动率不能作为长期透析患者HCV感染的敏感指标。     

肝炎基因诊断芯片检测肝炎患者血清及肝组织中HBVDNA、HCVRNA的临床研究

肝炎基因芯片是根据肝炎病毒的特征基因片段设计探针序列，将探针以微阵列形式排列在经过特殊处理的玻片上，从待测血液、组织标本中抽取微量肝炎病原体DNA（RNA），与探针杂交，用特有的荧光波长扫描芯片，通过计算机软件进行分析诊断。我们用病毒性肝炎基因诊断芯片，分别双盲检测40份乙型肝炎患者和健康人、丙型肝炎患者血清，99份肝炎后肝硬化肝组织蜡块标本，15份慢性乙型肝炎患者肝组织活检标本；同时用荧光微粒子定量法测定血清中乙型肝炎病毒标志物HBcAg，PCR法检测血清中HBVDNA、HCVRNA．用免疫组化法、原位分子杂交法分别检测肝组织HBcAg、HBVDNA。结果报道如下。     

聚合酶链反应杂交ELISA对肝炎患者血清HCV RNA的测定和分析

目的 应用丙型肝炎病毒（HCV）聚合酶链反应杂交酶联法（HCV－PCR－H ELISA）152份各型肝炎血清进行HCV RNA测定和分析。方法 利用标记生物素的寡核苷酸引物对患者血清进行PCR扩增，扩增产物与结合在微孔反应板的HCV特异探针快速杂交，通过抗生物素－酶联反应判定结果。结果 152份肝炎患者中，HCV RNA的检出率为57．9％（88／152），其中抗－HCV阳性组的检出率为81．8％（72／88）。抗－HCV与HCV RNA的总符合率为78．9％（120／152）。对5例丙型肝炎患者应用α干扰素治疗者追访显示，HCVRNA的消长与抗病毒药物疗效一致。结论 HCV－PCR－H ELISA方法简便、稳定、敏感、特异，为半定量指标，可应用于HCV感染的临床诊断和抗病毒药物疗效判定。     

常州地区丙型肝炎病毒基因分型及临床分析

目的:了解常州地区丙型肝炎病毒基因型分布、病毒复制与肝功能损害的关系。方法:对150例丙型肝炎病毒抗体检测为阳性的患者,采用荧光定量聚合酶链反应技术检测血清丙型肝炎病毒核糖核酸(HCVRNA)水平,并检测丙氨酸转氨酶(ALT)、天门冬氨酸转氨酶(AST)等肝功能相关指标,HCV基因分型采用基因芯片法。结果:150例患者中,HCV RNA阳性患者130例(>1×103IU/ml),HCV RNA阴性患者20例(<1×103IU/ml)。经相关性检验,HCV RNA阳性患者血清ALT、AST水平与HCV RNA含量表明无显著的相关性(P>0.05),HCV RNA阳性患者血清ALT和AST指标明显高于HCV RNA阴性患者(P<0.05)。对其中54例HCV RNA阳性标本进行HCV基因分型,1型有46例(85.19%),非1型8例(14.81%)。1型与非1型相比较,两组的血清ALT和AST水平没有明显差异(P>0.05)。结论:常州地区丙型肝炎病毒感染以1型病毒为主;持续的丙型肝炎病毒复制与肝功能损害密切相关;病毒载量与肝功能检测对丙型肝炎的治疗有重要意义。     

人类免疫缺陷病毒Ⅰ型和丙型肝炎病毒核酸联合检测试剂的评价

目的 了解人类免疫缺陷病毒Ⅰ型（HIV-1）和丙型肝炎病毒（HCV）核酸联合检测试剂检测的敏感性、特异性以及检测中国不同亚型样品的适应性。方法 用酶联免疫试剂对来自于不同地区的HIV感染者或可疑感染者献血员样品进行HIV抗体和HCV抗体检测。对HIV抗体阳性者进行抗体确证。用HIV-1和HCV核酸联合检测试剂对样品进行检测，对初次检测阳性者，用HIV RNA和HCV RNA鉴别试剂单独检测，区分是HIV RNA阳性或是HCV RNA阳性。结果 74份HIV和HCV抗体均阳性的样品，HIV／HCV RNA检测也为阳性，5份HIV和HCV抗体均阴性的样品，HIV／HCV RNA检测也为阴性；84份HIV抗体确证为阳性的样品，有82份检测为HIVRNA阳性，7份HIV抗体阴性的样品检测均为HIV RNA阴性，12份HIV抗体不确定的样品，有6份检测为HIV RNA阳性；81份HCV抗体阳性样品中有70份检测为HCV RNA阳性，22份HCV抗体阴性样品中有18份检测为HCV RNA阴性，4份检测为HCV RNA阳性。结论 该试剂的灵敏度较高，尤其在HCV抗体阴性样品中检出HCV RNA阳性者。因此，可用于献血员筛查，减少窗口期的传播。     

酶联法抗-HCV和HCV-cAg联检对丙型肝炎实验室诊断的应用价值

目的 探讨联合丙型肝炎病毒核心抗原(HCV-cAg)及抗-HCV抗体酶联免疫检测对丙型肝炎实验室诊断的应用价值.方法 289份血清标本按抗-HCV阳性、弱阳性、阴性及HCV-cAg阳性、弱阳性及阴性分组,用PCR扩增法检测其HCV RNA含量.结果 单项抗-HCV阳性及弱阳性标本其HCV RNA检测阳性符合率分别为87...     

丙型肝炎病毒实验室检测技术的研究进展

丙型肝炎病毒（HCV）是一种主要经血液传播的肝炎病毒,是造成慢性肝炎、肝硬化甚至肝癌的主要病原之一。HCV属于黄病毒属,为单股正链的RNA病毒,基因组长度约9.6kb,含有单个开放阅读框架（ORF）,编码一个由约3010个氨基酸组成的多聚蛋白。到目前为止,丙型肝炎的实验室检测技术主要有抗-HCV检测、HCVRNA核酸扩增检测、HCV核心抗原的检测三种类型。现就HCV实验室检测的研究现状作一综述,为致病机理的研究及抗HCV药物的开发和疫苗的研制等提供理论依据。     

Twenty-four mini-pool HCV RNA screening outside a blood transfusion setting: results of a 2-year prospective study

The usefulness of 24 mini-pool hepatitis C virus (HCV) RNA screening was evaluated in a 2-year prospective study carried out on a total of 6432 consecutive anti-HCV negative specimens in a routine diagnostic laboratory setting. A total of 268 mini-pools were tested using an automated commercial PCR assay for qualitative detection of HCV RNA, with a lower limit of detection of 50 IU/ml. Eighteen (0.28%) anti-HCV negative/HCV RNA positive serum samples obtained from 12 patients (all intravenous drug users), were detected. Ten patients responded to an invitation for follow-up testing. Five, three and one patient seroconverted in the first, second and third follow-up sample, respectively. One patient had not seroconverted by the end of the study period. The interval between the first HCV RNA positive sample and the first anti-HCV positive samples was 24–192 days. The costs of detecting a single anti-HCV negative/HCV RNA positive sample and a single anti-HCV negative/HCV RNA positive patient using the 24 mini-pool HCV RNA screening strategy were estimated to be around €643 and 965, respectively. It was shown that screening for HCV infection using the 24 mini-pool HCV RNA screening strategy can also be both useful and cost effective outside a blood transfusion setting.     

The natural history of community-acquired hepatitis C in the United States. The Sentinel Counties Chronic non-A, non-B Hepatitis Study Team.

BACKGROUND. Chronic liver disease develops in more than half of patients with post-transfusion hepatitis C, but little is known about the natural history of community-acquired hepatitis C. METHODS. In 1985 and 1986 we identified adults with acute non-A, non-B hepatitis in four counties in the United States and followed them prospectively. We used three markers to detect hepatitis C virus (HCV) infection in stored samples of serum: antibody to HCV (anti-HCV) detected by second-generation serologic assays; HCV RNA detected by polymerase-chain-reaction assay; and antibody to HCV antigen (anti-HCVAg) detected by fluorescent-antibody-blocking assay. RESULTS. Of 130 patients with non-A, non-B hepatitis, 106 (82 percent) had HCV infection, 93 were positive for anti-HCV, and 13 were positive only for HCV RNA or anti-HCVAg. Chronic hepatitis developed in 60 (62 percent) of 97 HCV-infected patients followed for 9 to 48 months, with no relation to the risk factors for infection. Ten of the 30 patients who had liver biopsies had chronic active hepatitis. In samples collected 42 to 48 months after the onset of hepatitis, HCV RNA was detected in 12 of 13 tested patients with chronic hepatitis and in all 15 tested patients with hepatitis that had resolved. Anti-HCV persisted in all but two of the initially positive patients, for a rate of antibody loss of 0.6 per 100 person-years. CONCLUSIONS. Patients with community-acquired hepatitis C have a high rate of chronic hepatitis. HCV may be a major cause of chronic liver disease in the United States, and in most patients HCV infection seems to persist for at least several years, even in the absence of active liver disease.     

丙型肝炎病毒感染的血清学检测

目的了解丙型肝炎病毒（ＨＣＶ）感染及病毒血症存在情况。方法用酶联免疫吸附试验（ＥＬＩＳＡ）和聚合酶链反应（ＰＣＲ）对不同人群的血清标本做了抗－ＨＣＶ、抗－ＨＣＶＩｇＭ和ＨＣＶＲＮＡ的检测，并对三项指标间的关系进行了对比分析。结果抗－ＨＣＶ在普通成年人、献血员、急性肝炎和肝硬化患者中的检出率分别是３５７％，８５８％，６２５％和４８３８％；与ＨＣＶＲＮＡ的符合率分别是１１４３％，６１１１％，８００％和７３３３％。相同人群抗－ＨＣＶＩｇＭ与ＨＣＶＲＮＡ的符合率分别是７５％，９０９％，８１８１％和１００％。结论抗－ＨＣＶＩｇＭ比抗－ＨＣＶ能更客观地反映ＨＣＶ病毒血症的情况，个别抗－ＨＣＶ阴性血清检测到了抗－ＨＣＶＩｇＭ和ＨＣＶＲＮＡ。     

Twenty-four mini-pool HCV RNA screening in a routine clinical virology laboratory setting: a six-year prospective study

The usefulness of combined anti-HCV and 24 mini-pool HCV RNA screening strategy was re-evaluated after a six-year continuous routine use in a clinical virology laboratory, at which more than half of newly diagnosed hepatitis C patients are intravenous drug users. Pools of 24 samples were prepared from 20,448 anti-HCV negative serum samples and tested using an automated commercial PCR assay with a lower limit of detection of 50 IU/ml. After detection of anti-HCV negative/HCV RNA positive patients, responsible physicians provided follow-up samples. Thirty-eight (0.19%) anti-HCV negative/HCV RNA positive samples from 30 patients (28 intravenous drug users) were detected. Follow-up samples were available for 27/30 patients. Twenty, six and one patient seroconverted in the second, third and fourth available samples, respectively. The interval between the first HCV RNA positive and the first available anti-HCV positive sample was 17-517 days. The costs of detecting a single anti-HCV negative/HCV RNA positive patient were 1227 Euros. Combined anti-HCV and 24 mini-pool HCV RNA screening is a useful and cost effective strategy, not only in blood-transfusion settings but also in a routine clinical virology laboratory, at which a significant proportion of the tested population belongs to a high-risk population.     

Simultaneous detection of hepatitis C virus (HCV) core antigen and anti-HCV antibodies improves the early detection of HCV infection

To evaluate whether a new enzyme immunoassay developed for the simultaneous detection of hepatitis C virus (HCV) core antigen (Ag) and anti-HCV antibodies (anti-HCV Ab) (Monolisa HCV Ag/Ab ULTRA; Bio-Rad) could improve the early detection of HCV infection, we compared its sensitivity to that of anti-HCV, HCV core Ag, and HCV RNA assays. The populations studied included 12 blood donor samples positive for HCV RNA and HCV core Ag but negative for anti-HCV antibodies and 23 hemodialysis patients who developed anti-HCV Ab (seroconversion) during the follow-up. From these 23 individuals, 83 samples sequentially collected prior to seroconversion and 108 samples collected after seroconversion were tested. Six of 12 blood donations were positive by the HCV Ag/Ab assay. In the hemodialysis cohort, the 24 HCV RNA-negative samples were negative by the HCV Ag/Ab assay and 23 of the 59 HCV RNA-positive samples (39%) were positive. The HCV Ag/Ab assay detected HCV infection on average 21.6 days before the most sensitive antibody assay. The HCV Ag/Ab assay did not detect HCV infection as early as the HCV RNA assay (mean delay, 30.3 days) or HCV Ag assay (mean delays, 27.9, and 16.3 days by the HCV core Ag quantification assay and the HCV Ag blood screening assay, respectively). This new assay provides a notable improvement for the early detection of HCV infection during the so-called window period compared with anti-HCV Ab assays and could be a useful alternative to HCV RNA detection or HCV core Ag assays for diagnosis or blood screening when nucleic acid technologies or HCV core Ag detection are not implemented.     

Sensitivity of a modified version of the ARCHITECT Anti-HCV test in detecting samples with immunoblot-confirmed, low-level antibody to hepatitis C virus.

BACKGROUND AND OBJECTIVES: Compliance with current regulations regarding the prevention of hepatitis C virus (HCV) transmission in the blood transfusion setting requires the use of sensitive assays for HCV antibody (anti-HCV) detection, which should, ideally, identify any donor having had prior contact with the virus. Therefore, low-level anti-HCV positive blood units should be detected by the screening assays, even those reflecting a past and resolved infection. To assess the sensitivity of two versions of an automated chemiluminescent microparticle immunoassay (CMIA) for anti-HCV screening (ARCHITECT Anti-HCV), 113 single serum samples containing low levels of anti-HCV, assessed by two immunoblot tests, were selected from 3686 samples received for confirmation of HCV infection by a reference laboratory over a 2-year period. MATERIALS AND METHODS: The panel included 17 samples with HCV RNA detected by the polymerase chain reaction (PCR) and 96 PCR negative samples with either positive or indeterminate (anti-Core and anti-NS3 alone) results by immunoblot. RESULTS: All but 13 specimens (100/113, 88.5%) were detected by the current version of the ARCHITECT Anti-HCV assay and 10 additional samples (110/113, 97.3%) tested positive in a modified version of the test. CONCLUSION: The results showed that the modification introduced in the ARCHITECT Anti-HCV assay achieves a significant sensitivity improvement including samples with low-level anti-HCV which are either PCR positive or negative.     

Hepatitis C virus infection in post-transfusion hepatitis. An analysis with first- and second-generation assays.

BACKGROUND. The causes of post-transfusion non-A, non-B hepatitis are still not fully defined, nor is it clear how accurate the tests are that are used to screen blood donors for hepatitis C virus (HCV) and to diagnose post-transfusion hepatitis caused by infected blood. METHODS. We used two first-generation enzyme-linked immunoassays (EIAs) and one second-generation immunoassay to test for anti-HCV antibodies in serum samples collected between 1976 and 1979 in the Transfusion-Transmitted Viruses Study (from 1247 patients who underwent transfusion and 1235 matched control subjects who did not receive transfusions). We tested serum collected before and after infection from the patients in whom non-A, non-B hepatitis developed, serum from their blood donors, and serum from 41 of the control subjects who had hepatitis unrelated to transfusion. RESULTS. Of the 115 patients in whom post-transfusion non-A, non-B hepatitis developed, the initial serum samples of 111 were anti-HCV-negative; after hepatitis developed in these 111 patients, the first-generation EIAs detected anti-HCV in 51 (46 percent), and the second-generation assay detected anti-HCV in an additional 16 (14 percent), for a total of 60 percent. Of 40 controls, 37 were anti-HCV-negative initially, and none seroconverted after hepatitis developed. If the 3 percent rate of non-A, non-B, non-C hepatitis among the controls (37 of 1235) was applied to the 1247 transfusion recipients, only 74 of the 111 cases of hepatitis were attributable to the transfusion. Thus, 91 percent (67 of 74) of the cases of post-transfusion hepatitis were caused by HCV. Of the 99 donors, 60 were HCV-positive (9 on second-generation tests only) and 39 were not. CONCLUSIONS. Nearly all cases of non-A, non-B post-transfusion hepatitis are caused by HCV. Screening with a second-generation assay improves the rate of detection of HCV infection in patients with post-transfusion hepatitis and in blood donors. The use of this test showed a 3.6 percent risk of non-A, non-B, non-C hepatitis, which was not significantly different from the rate in the controls (3.0 percent).     

Clinical significance of antibodies to nonstructural and core proteins of hepatitis C virus in posttransfusion hepatitis patients during long-term follow-up

The prevalence of hepatitis C antibodies (anti- HCV) among multitransfused patients was studied and compared with predicted values obtained from a post-transfusion hepatitis study and from data on the prevalence of anti-HCV among blood donors. The prevalence of hepatitis B core antibodies (anti-HBc) was also studied to determine the routes of transmission of hepatitis C virus. The patients consisted of 65 dialysis patients (57 on haemodialysis and 8 on continuous ambulatory peritoneal dialysis) and 71 leukemia patients in long-term remission [49 with acute myeloid leukemia (AML) and 22 with acute lymphatic leukemia (ALL)]. The presence of anti-HCV was investigated using a second generation enzyme-linked immunosorbent assay. Reactive samples were confirmed by a second generation recombinant immunoblot assay. Anti-HBc was studied in the 65 dialysis patients and in 40 of the leukemia patients. Three (4.6%) of the 65 dialysis patients and 12 (24.5%) of the 49 AML patients were anti-HCV positive whereas all of the ALL patients were seronegative. The total number of blood units transfused to 134 patients (data on two dialysis patients were not available) was 18,148, out of which 17,575 units had been transfused prior to the initiation of anti- HCV screening of blood donors. On the basis of the anti-HCV prevalence among blood donors and the incidence of post-transfusion hepatitis, the predicted number of seropositive patients was 11 and 18, respectively. Five of the 65 dialysis patients were anti-HBc positive, compared with only one of the 40 leukemia patients. It is concluded that the anti-HCV prevalence among dialysis and leukemia patients is concordant with the risk of receiving contaminated blood products, whereas hepatitis B infection may have other routes of transmission in dialysis patients. © 1993 Wiley-Liss, Inc.     

The declining risk of post-transfusion hepatitis C virus infection.

BACKGROUND. The most common serious complication of blood transfusion is post-transfusion hepatitis from the hepatitis C virus (HCV). Blood banks now screen blood donors for surrogate markers of non-A, non-B hepatitis and antibodies to HCV, but the current risk of post-transfusion hepatitis C is unknown. METHODS. From 1985 through 1991, blood samples and medical information were obtained prospectively from patients before and at least six months after cardiac surgery. The stored serum samples were tested for antibodies to HCV by enzyme immunoassay, and by recombinant immunoblotting if positive. RESULTS. Of the 912 patients who received transfusions before donors were screened for surrogate markers, 35 seroconverted to HCV, for a risk of 3.84 percent per patient (0.45 percent per unit transfused). For the 976 patients who received transfusions after October 1986 with blood screened for surrogate markers, the risk of seroconversion was 1.54 percent per patient (0.19 percent per unit). For the 522 patients receiving transfusions since the addition in May 1990 of screening for antibodies to HCV, the risk was 0.57 percent per patient (0.03 percent per unit). The trend toward decreasing risk with increasingly stringent screening of donors was statistically significant (P less than 0.001). After we controlled for the method of donor screening, the risk of seroconversion was strongly associated (P less than 0.001) with the volume of blood transfused, but not with the use of particular blood components. CONCLUSIONS. The incidence of post-transfusion hepatitis C has decreased markedly since the implementation of donor screening for surrogate markers and antibodies to HCV. The current risk of post-transfusion hepatitis is about 3 per 10,000 units transfused.     

Multicenter clinical evaluation of the new 3rd generation assay for detection of antibodies against hepatitis C virus on the VIDAS® system

BackgroundDetection of antibodies (anti-HCV) against hepatitis C virus (HCV) is indispensable for screening and diagnosis of viral hepatitis and for the viral safety of blood, tissue or organ donations. It gains additional importance by the new HCV drugs which improve the therapeutic possibilities dramatically.ObjectiveTo evaluate the performance of a newly developed immune assay for anti-HCV based on the well-established VIDAS platform.Study designThe assay was evaluated with samples from anti-HCV negative blood donors and from patients with or without HCV markers in six centres in France, Spain and Egypt. The status of the samples was determined by using CE-marked immune assays (Architect, AxSym, Prism, Vitros), two immunoblots (RIBA, Inno-Lia) and/or HCV RNA results.ResultsSpecificity was 99.67% in 10,320 French blood donors without anti-HCV, 99.5% in 200 anti-HCV negative hospitalized European patients and 99.0% in 198 negative patients from Egypt. Sensitivity was 99.7% in 1054 patients pretested positive by other assays; 345 patients with known genotype had genotype 1–6; 61 patients were co-infected with HIV. VIDAS was reactive in 78% of 91 patients with uncertain or very weak anti-HCV. It became on average positive at day 37 with seroconversion panels.ConclusionsThis multicentric, international study with >12,000 samples show that the new VIDAS anti-HCV assay is very suitable for screening and confirmation of HCV infection. Sensitivity, specificity and recognition of seroconversion compare favorably with well-established CE-marked tests and help to clarify discrepant results obtained with other assays.