MUTATED HEV POLYPEPTIDES AND THE USE THEREOF FOR ASSAYING ANTI-HEV ANTIBODIES

    公开(公告)号:US20180328929A1

    公开(公告)日:2018-11-15

    申请号:US15774366

    申请日:2016-11-29

    申请人: BIOMERIEUX

    摘要: Polypeptides of the p-ORF2 protein of the hepatitis E virus, including at least the amino acid sequence 394-660, numbered in relation to a p-ORF2 protein of 660 amino acids, in which the three cysteines at positions 627, 630 and 638 have been mutated or, for a p-ORF2 protein of different length, at least the amino acid sequence corresponding to amino acids 394-660 of the p-ORF2 protein of 660 amino acids, in which the three cysteines located at the three positions corresponding to positions 627, 630 and 638 of the p-ORF2 protein of 660 amino acids have been mutated. Also, methods for determining the presence of the humoral response or the titer of antibodies directed against the p-ORF2 protein using these polypeptides, and also the use thereof in the context of infection with the hepatitis E virus.

    Method and kit for the detection of hepatitis-specific antibodies

    公开(公告)号:US09651557B2

    公开(公告)日:2017-05-16

    申请号:US14383574

    申请日:2013-03-07

    CPC分类号: G01N33/576

    摘要: The present invention relates to an improved method for detecting antibodies to a hepatitis virus in a tissue sample from individuals, which can reliably detect antibodies in recently infected individuals and which provides much lower false positive results in individuals that have cleared their hepatitis infections. More particularly, the present invention relates to an improved method and kit which utilizes an activator of (i) hepatitis virus-primed lymphocytes, (ii) memory cells specific for said hepatitis virus, (iii) hepatitis virus-specific antibody production, or (iv) a combination thereof in a tissue sample to stimulate the production of antibodies from newly primed B cells, if present.

    PROGNOSTIC TESTS FOR HEPATIC DISORDERS
    34.
    发明申请
    PROGNOSTIC TESTS FOR HEPATIC DISORDERS 审中-公开
    恶性疾病的预防性检测

    公开(公告)号:US20170032099A1

    公开(公告)日:2017-02-02

    申请号:US15302708

    申请日:2015-04-08

    IPC分类号: G06F19/00 G06F17/18

    摘要: An in vitro prognostic method for assessing the risk of death or of liver-related event in a subject, includes: a) obtaining at least one, preferably 2, of the following variables from the subject: i. biomarkers measured in a sample from the subject; ii. clinical data; iii. binary markers; iv. blood test results; b) optionally obtaining at least one blood test result by univariate combination, preferably with a binary logistic regression, of the at least one variable obtained in step a), the blood test not being a Fibrotest, c) obtaining at least one physical data from medical imaging or clinical measurement, from elastometry, or Vibration Controlled Transient Elastography, and d) mathematically combining in a multivariate time-dependent model the variable obtained in step a) and/or the at least one blood test result obtained in step b); and the at least one physical data, obtained in step c) thereby obtaining a prognostic score.

    摘要翻译: 用于评估受试者的死亡风险或肝脏相关事件的体外预后方法包括:a)从受试者获得以下变量中的至少一个,优选2个:i。 在受试者的样本中测量的生物标志物; ii。 临床资料; iii。 二进制标记 iv。 血液检测结果; b)任选地通过单因素组合获得至少一个血液检测结果,优选用二元逻辑回归方法获得步骤a)中获得的至少一个变量,血液测试不是Fibrotest,c)获得至少一个物理数据 医学成像或临床测量,弹性测量或振动控制瞬态弹性成像,以及d)在多变量时间依赖模型中数学组合步骤a)中获得的变量和/或步骤b)中获得的至少一个血液测试结果; 以及步骤c)中获得的至少一个物理数据,从而获得预后评分。

    Monoclonal antibody against hepatitis E virus or its fragment with binding activity and use thereof
    35.
    发明授权
    Monoclonal antibody against hepatitis E virus or its fragment with binding activity and use thereof 有权
    针对戊型肝炎病毒的单克隆抗体或其具有结合活性的片段及其用途

    公开(公告)号:US09428554B2

    公开(公告)日:2016-08-30

    申请号:US12433497

    申请日:2009-04-30

    摘要: The present invention relates to monoclonal antibody specifically binding to polypeptide(s) comprising the amino acid sequence as set forth in SEQ ID No. 1 of hepatitis E virus ORF2 or its conserved variants or its active fragments, or other monoclonal antibodies against ORF2 which can cross react with said monoclonal antibody of present invention, and its nucleotide sequence or its degenerate sequence; to the antigenic determinant in hepatitis E virus ORF2; to a method for screening isolated or recombined polypeptide or polypeptide analog, which has the same property of specifically binding said monoclonal antibody 8C11 and/or 8H3 as said antigenic determinant 1) or 3) of hepatitis E virus ORF2; to polypeptide or polypeptide analog screened by the method above and its nucleotide sequence or degenerate sequence; to a use of said polypeptide or polypeptide analog in preparation of a medicament for the diagnosis and/or precaution of hepatitis E virus infection; to a diagnostic kit for hepatitis E virus infection and a vaccine composition for prophylaxis of hepatitis E virus infection; to use of said monoclonal antibodies or their active fragments or conserved variants in preparation of a medicament for diagnosis, prophylaxis and/or treatment of hepatitis E virus infection; to pharmaceutical composition for prophylaxis and/or treatment of hepatitis E virus infection and a method for prophylaxis and/or treatment of hepatitis E virus infection; to a recombinant expression vector comprising said nucleotide molecule in present invention and a host cell transformed with said recombinant expression vector that is able to express monoclonal antibody and its conserved variants or active fragments or polypeptide or polypeptide analogs.

    摘要翻译: 本发明涉及与多肽特异性结合的单克隆抗体,其包含如戊型肝炎病毒ORF2的SEQ ID No.1所示的氨基酸序列或其保守变体或其活性片段或针对ORF2的其它单克隆抗体,其可以 与本发明的单克隆抗体交叉反应,其核苷酸序列或其简并序列; 对乙型肝炎病毒ORF2的抗原决定簇; 涉及用于筛选分离或重组的多肽或多肽类似物的方法,其具有与所述单克隆抗体8C11和/或8H3特异性结合作为所述抗原决定簇1)或3)的戊型肝炎病毒ORF2的相同性质; 通过上述方法筛选的多肽或多肽模拟物及其核苷酸序列或简并序列; 涉及所述多肽或多肽类似物在制备用于诊断和/或预防戊型肝炎病毒感染的药物中的用途; 用于戊型肝炎病毒感染的诊断试剂盒和用于预防戊型肝炎病毒感染的疫苗组合物; 在制备用于诊断,预防和/或治疗戊型肝炎病毒感染的药物中使用所述单克隆抗体或其活性片段或保守变体; 用于预防和/或治疗戊型肝炎病毒感染的药物组合物和预防和/或治疗戊型肝炎病毒感染的方法; 涉及包含本发明中的所述核苷酸分子和能够表达单克隆抗体及其保守变体或活性片段或多肽或多肽类似物的所述重组表达载体转化的宿主细胞的重组表达载体。

    CLINICAL DIAGNOSIS OF HEPATIC FIBROSIS USING A NOVEL PANEL OF HUMAN SERUM PROTEIN BIOMARKERS
    36.
    发明申请
    CLINICAL DIAGNOSIS OF HEPATIC FIBROSIS USING A NOVEL PANEL OF HUMAN SERUM PROTEIN BIOMARKERS 审中-公开
    使用人类血清蛋白生物标志物的新面板进行的肝脏纤维化的临床诊断

    公开(公告)号:US20160077109A1

    公开(公告)日:2016-03-17

    申请号:US14690539

    申请日:2015-04-20

    IPC分类号: G01N33/68 G01N33/576

    摘要: The inventors have proposed a novel panel of human serum protein biomarkers for diagnosing hepatic fibrosis and cirrhosis. Presently there is no reliable non-invasive way of assessing liver fibrosis. A 2D-PAGE based proteomics study was used to identify potential fibrosis biomarkers. Serum from patients with varying degrees of hepatic scarring induced by infection with the hepatitis C virus (HCV) was analysed. Several proteins associated with liver scarring and/or viral infection were identified. These proteins include the inter-α-trypsin inhibitor heavy chain H4 fragments, complement factor H-related protein 1, CD5L, Apo L1, and β2GPI. Increased and decreased thiolester cleavage of a2M and Complement C3, respectively, was also detected. The concentrations of these novel biomarkers can be determined using an immunoassay where the concentrations would reflect the extent of fibrosis. A fibrosis scoring scale for each of the novel biomarkers is proposed. The additive result from the scores of all the novel biomarkers would give a more reliable indication of the degree of fibrosis rather than examining individual biomarkers.

    摘要翻译: 本发明人提出了用于诊断肝纤维化和肝硬化的人类血清蛋白生物标志物的新颖小组。 目前尚无可靠的非侵入性肝纤维化评估方法。 使用基于2D-PAGE的蛋白质组学研究来鉴定潜在的纤维化生物标志物。 分析了丙型肝炎病毒(HCV)感染引起肝脏瘢痕形成程度不同的患者血清。 鉴定了与肝脏瘢痕形成和/或病毒感染相关的几种蛋白质。 这些蛋白质包括α-间胰蛋白酶抑制剂重链H4片段,补体因子H相关蛋白1,CD5L,Apo L1和&bgr; 2GPI。 还检测到了分别增加和减少的a2M和补体C3的硫醇裂解。 这些新型生物标志物的浓度可以使用免疫测定来确定,其中浓度将反映纤维化程度。 提出了每种新型生物标志物的纤维化评分量表。 所有新生物标志物的得分的添加剂结果将给出更可靠的纤维化程度的指示,而不是检查个体生物标志物。

    METHODS FOR DETECTION OF BIOLOGICAL SUBSTANCES
    37.
    发明申请
    METHODS FOR DETECTION OF BIOLOGICAL SUBSTANCES 审中-公开
    检测生物物质的方法

    公开(公告)号:US20150366869A1

    公开(公告)日:2015-12-24

    申请号:US14601387

    申请日:2015-01-21

    申请人: Robert I. HENKIN

    发明人: Robert I. HENKIN

    摘要: The invention is directed to a method of detecting a biological substance in the nasal secretion and diagnosing a disease following the detection of the biological substance wherein the biological substance is not related to a respiratory disease. The invention also provides treatment of the diseases following the detection of the biological substance and/or diagnosis of the disease. In some embodiments, the diseases are cancer, hepatitis, smell loss, taste loss, diabetes, and leprosy. The invention also provides a kit for diagnosing a disease.The present invention includes methods of analyzing samples from the nose for the detection of biological substances. In particular, nasal secretion or nasal mucus is collected and analyzed for biological substances. The results of this analysis are then suitable for use in diagnosis, prognosis, and determination of suitability of therapeutic interventions.

    摘要翻译: 本发明涉及一种检测鼻分泌物中的生物物质的方法,并且在检测到生物物质与生物物质与呼吸系统疾病无关之后诊断疾病。 本发明还提供了在检测生物物质和/或诊断疾病之后的疾病的治疗。 在一些实施方案中,疾病是癌症,肝炎,气味丧失,味觉丧失,糖尿病和麻风病。 本发明还提供了用于诊断疾病的试剂盒。 本发明包括分析来自鼻子的样品用于检测生物物质的方法。 特别地,收集鼻分泌物或鼻粘液并分析生物物质。 该分析结果适用于诊断,预后和治疗干预适合性的测定。

    Clinical diagnosis of hepatic fibrosis using a novel panel of human serum protein biomarkers
    39.
    发明授权
    Clinical diagnosis of hepatic fibrosis using a novel panel of human serum protein biomarkers 有权
    使用人血清蛋白生物标志物的新型小组对肝纤维化进行临床诊断

    公开(公告)号:US09012162B2

    公开(公告)日:2015-04-21

    申请号:US11851619

    申请日:2007-09-07

    IPC分类号: G01N33/00 G01N33/576

    摘要: The inventors have proposed a novel panel of human serum protein biomarkers for diagnosing hepatic fibrosis and cirrhosis. Presently there is no reliable non-invasive way of assessing liver fibrosis. A 2D-PAGE based proteomics study was used to identify potential fibrosis biomarkers. Serum from patients with varying degrees of hepatic scarring induced by infection with the hepatitis C virus (HCV) was analyzed. Several proteins associated with liver scarring and/or viral infection were identified. These proteins include the inter-α-trypsin inhibitor heavy chain H4 fragments, complement factor H-related protein 1, CD5L, Apo L1, and β2GPI. Increased and decreased thiolester cleavage of a2M and Complement C3, respectively, was also detected. The concentrations of these novel biomarkers can be determined using an immunoassay where the concentrations would reflect the extent of fibrosis. A fibrosis scoring scale for each of the novel biomarkers is proposed. The additive result from the scores of all the novel biomarkers would give a more reliable indication of the degree of fibrosis rather than examining individual biomarkers.

    摘要翻译: 本发明人提出了用于诊断肝纤维化和肝硬化的人类血清蛋白生物标志物的新颖小组。 目前尚无可靠的非侵入性肝纤维化评估方法。 使用基于2D-PAGE的蛋白质组学研究来鉴定潜在的纤维化生物标志物。 分析了丙型肝炎病毒(HCV)感染引起肝脏瘢痕形成程度不同的患者血清。 鉴定了与肝脏瘢痕形成和/或病毒感染相关的几种蛋白质。 这些蛋白质包括α-间胰蛋白酶抑制剂重链H4片段,补体因子H相关蛋白1,CD5L,Apo L1和&bgr; 2GPI。 还检测到了分别增加和减少的a2M和补体C3的硫醇裂解。 这些新型生物标志物的浓度可以使用免疫测定来确定,其中浓度将反映纤维化程度。 提出了每种新型生物标志物的纤维化评分量表。 所有新生物标志物的得分的添加剂结果将给出更可靠的纤维化程度的指示,而不是检查个体生物标志物。

    EXOSOME-MEDIATED DIAGNOSIS OF HEPATITIS VIRUS INFECTIONS AND DISEASES
    40.
    发明申请
    EXOSOME-MEDIATED DIAGNOSIS OF HEPATITIS VIRUS INFECTIONS AND DISEASES 有权
    异位传染性病毒性肝炎病毒感染和疾病诊断

    公开(公告)号:US20140134606A1

    公开(公告)日:2014-05-15

    申请号:US14159612

    申请日:2014-01-21

    IPC分类号: C12Q1/70

    摘要: A method for diagnosing hepatitis virus infection or a hepatitis disease condition in a subject based on hepatitis virus-associated biomarkers present on exosomes in a bodily fluid sample from the subject is disclosed. Also disclosed are a method for monitoring the course of a hepatitis virus infection or a hepatitis disease condition in a subject and a method for monitoring effectiveness of treatment to a subject with an anti-hepatitis virus agent based on hepatitis virus-associated biomarkers present on exosomes in bodily fluid samples from the subject, as well as a kit for diagnosing hepatitis virus infection and/or a hepatitis disease condition in a subject based on hepatitis virus-associated biomarkers on exosomes in bodily fluid samples from the subject.

    摘要翻译: 公开了一种用于诊断受试者中基于肝炎病毒相关生物标志物的肝炎病毒感染或肝炎病症的方法,所述肝炎病毒相关生物标志物存在于来自受试者的体液样品中的外来体上。 还公开了一种用于监测受试者中肝炎病毒感染或肝炎疾病状况的过程的方法以及基于存在于外来体上的肝炎病毒相关生物标志物来监测具有抗肝炎病毒剂的受试者治疗有效性的方法 来自受试者的体液样本,以及用于诊断受试者中基于肝炎病毒相关生物标志物的肝炎病毒感染和/或肝炎疾病状况的试剂盒,其来自受试者的体液样品中的外来体。