Trends in residual risk of transfusion‐transmitted viral infections in France between 1992 and 2000

Pillonel, Josiane; Laperche, Syria; Saura, C.; Desenclos, Jean‐Claude; Couroucé, Anne‐Marie

doi:10.1046/j.1537-2995.2002.00155.x

Cited by 90 publications

(65 citation statements)

References 39 publications

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“…This increased sensitivity of the last-generation assays has dramatically reduced the risk of HCV transmission by blood components by reducing the window period from 82 days (5) to 66 days (3,12). To further reduce the residual risk (2,5,16,18,36,37,41,48), nucleic acid testing (NAT) for HCV RNA was introduced in several high-income countries (2,14,15,21,30,39). In some countries, an assay for the detection of HCV core antigen (Ag) by use of the enzyme immunoassay (EIA) technology has been chosen as an alternative to NAT for the early diagnosis of infection (1,8,25,38).…”

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confidence: 99%

Simultaneous Detection of Hepatitis C Virus (HCV) Core Antigen and Anti-HCV Antibodies Improves the Early Detection of HCV Infection

et al. 2005

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Since the development of the first assay in 1989 (20), assays for detection of hepatitis C virus (HCV) antibodies (Ab) have allowed progress in the early detection of HCV infection (46). This increased sensitivity of the last-generation assays has dramatically reduced the risk of HCV transmission by blood components by reducing the window period from 82 days (5) to 66 days (3, 12). To further reduce the residual risk (2,5,16,18,36,37,41,48), nucleic acid testing (NAT) for HCV RNA was introduced in several high-income countries (2,14,15,21,30,39). In some countries, an assay for the detection of HCV core antigen (Ag) by use of the enzyme immunoassay (EIA) technology has been chosen as an alternative to NAT for the early diagnosis of infection (1,8,25,38). In addition, some authors emphasized the clinical advantage of HCV core Ag quantification as a direct marker of viral replication in the chronic phase of infection (4) and as a relevant marker for predicting and monitoring the response to therapy (7,29,31). Indeed, the HCV core Ag assays have sensitivities close to that of NAT, with mean detection differences of 1 to 2 days in the window period with the specific assay developed for blood screening (11,32,35,45) and 0.29 day with the immunoassay capable of detecting and quantifying HCV core Ag (23). A recent study reported that a prototype assay based on the simultaneous detection of HCV core Ag and anti-HCV Ab significantly closed the time gap between HCV RNA detection and the first appearance of detectable anti-HCV Ab (42). However, this assay is not yet available for routine use. More recently, a new combination assay has been developed and licensed in Europe (Monolisa HCV Ag/Ab ULTRA; Bio-Rad, Marnes la Coquette, France). To assess its sensitivity for the detection of HCV infection during the window period or at the early phase after seroconversion, we tested two panels and compared the results with those obtained using the two available assays for HCV Ag (HCV core Ag EIA blood screening assay and trak-C assay) and HCV RNA. The overall objective was to determine if this new test could constitute an alternative to NAT for the diagnosis of HCV infection during the window period and whether the sensitivity for antibody detection is preserved. (Table 1) consisted of 12 blood donor samples which were negative for anti-HCV Ab (Ortho HCV 3.0 EIA test system Enhanced SAVe; Ortho Clinical Diagnostics, Raritan, NJ) but positive for HCV RNA. The plasma from each of these blood donations was immediately aliquoted and stored at Ϫ30°C until it was MATERIALS AND METHODS Panels

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Simultaneous Detection of Hepatitis C Virus (HCV) Core Antigen and Anti-HCV Antibodies Improves the Early Detection of HCV Infection

et al. 2005

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“…HCV currently affects approximately 3% of the world's population, and 70% of those individuals develop chronic HCV infection, which often progresses to liver cirrhosis and hepatocellular carcinomas (3,19,23). The incidence of posttransfusion HCV has steadily declined since the implementation of routine screening for HCV antibodies and HCV nucleic acid amplification testing among blood donors (21). Despite the proven utility of these assays for blood screening and for the diagnosis of HCV infection in symptomatic patients, important challenges to the improvement of immunoassay performance remain.…”

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Design of Novel Conformational and Genotype-Specific Antigens for Improving Sensitivity of Immunoassays for Hepatitis C Virus-Specific Antibodies

Lin¹,

Arcangel²,

Medina-Selby³

et al. 2005

J Clin Microbiol

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The current commercially licensed enzyme-linked immunosorbent assays (ELISAs) for hepatitis C virus (HCV) mainly use recombinant proteins containing linear epitopes. There is evidence, however, that conformational epitopes of HCV are more immunoreactive. Thus, we have designed an HCV antibody assay that employs a conformational protein, NS3NS4a PI (with functional protease and helicase activities), and a linear fusion protein, multiple-epitope fusion antigen 7.1 (MEFA 7.1) or MEFA 7.2. We have shown that NS3NS4a PI detects early-seroconversion conformation-sensitive antibodies better than c33c antigen. The correct conformation of NS3NS4a PI also cross-reacts with different genotype samples better than the c33c antigen. MEFA 7.1 and MEFA 7.2 incorporate all the major immunodominant and genotype-specific epitopes of HCV core, E1, E2 hypervariable region 1 (HVR1), E2 HVR1-plus-HVR2 consensus, NS3, NS4, and NS5. Since MEFA 7.1 is degraded by the active NS3NS4a PI protease, we designed a second MEFA 7.2 construct in which the six protease cleavage sites found in MEFA 7.1 were eliminated by amino acid mutation. We demonstrate here that MEFA 7.2 remains intact in the presence of NS3NS4a PI and preserves the epitopes present in MEFA 7.1. Compared to currently licensed assays, an ELISA incorporating a combination of the two antigens NS3NS4a PI and MEFA 7.1 or 7.2 demonstrates better serotype sensitivity and detects seroconversion earlier in many commercially available panels. We believe that an assay using NS3NS4a PI and MEFA 7.1 or 7.2 may have the potential to replace current HCV immunoassays for better sensitivity.Hepatitis C virus (HCV) is the major etiologic agent for blood transfusion-associated and community-acquired non-A, non-B viral hepatitis (1,9,19). HCV currently affects approximately 3% of the world's population, and 70% of those individuals develop chronic HCV infection, which often progresses to liver cirrhosis and hepatocellular carcinomas (3,19,23). The incidence of posttransfusion HCV has steadily declined since the implementation of routine screening for HCV antibodies and HCV nucleic acid amplification testing among blood donors (21). Despite the proven utility of these assays for blood screening and for the diagnosis of HCV infection in symptomatic patients, important challenges to the improvement of immunoassay performance remain. Such challenges include detecting antibody earlier, improving the detection of HCV samples from immunosuppressed patients, and increasing assay sensitivity to detect antibodies to the different HCV genotype-specific epitopes.HCV is an enveloped virus with a single-stranded positivesense RNA genome of approximately 9.5 kb that encodes about 3,010 amino acids (10, 24). The HCV polyprotein is processed by host and viral proteases into several mature proteins: core protein (C), envelope glycoproteins (E1 and E2), and six nonstructural proteins (NS2, NS3, NS4a, NS4b, NS5a, NS5b) (14,17). NS3 is a 630-amino-acid protein with three enzymatic activities: the N-terminal 180 amino ...

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“…A pesar de estas medidas, existe un riesgo residual de transmitir esta infección a través de transfusiones de productos sanguíneos, el cual se asocia principalmente al periodo de incubación de la enfermedad, periodo en el cual los marcadores serológicos de infección podrían no ser detectados y a donantes de sangre que presentan una infección oculta por VHB caracterizada por ausencia de marcadores serológicos asociadas por lo general con una baja carga de ADN [4][5][6] .…”

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Seroprevalencia de virus hepatitis B en niños con cáncer en tratamiento quimioterápico en 6 hospitales de Santiago de Chile

Zubieta¹,

Santolaya

Hurtado

et al. 2009

Rev. méd. Chile

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Trends in residual risk of transfusion‐transmitted viral infections in France between 1992 and 2000

Abstract: In France, the current risk of a blood recipient becoming infected with a retrovirus or a hepatitis virus is extremely low. The implementation of NAT in July 2001 is predicted to reduce the residual risk to 1 in 2,700,000 donations for HIV and 1 in 8,300,000 for HCV.

Cited by 90 publications

References 39 publications

Simultaneous Detection of Hepatitis C Virus (HCV) Core Antigen and Anti-HCV Antibodies Improves the Early Detection of HCV Infection

Simultaneous Detection of Hepatitis C Virus (HCV) Core Antigen and Anti-HCV Antibodies Improves the Early Detection of HCV Infection

Design of Novel Conformational and Genotype-Specific Antigens for Improving Sensitivity of Immunoassays for Hepatitis C Virus-Specific Antibodies

Seroprevalencia de virus hepatitis B en niños con cáncer en tratamiento quimioterápico en 6 hospitales de Santiago de Chile

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