Confirmation of hepatitis C virus infection by new four-antigen recombinant immunoblot assay

Poel, C.L. van der; Reesink, H. W.; Boven, J. J. P. Van; Cuypers, H. T. M.; Winkel, I.N.; Exel-Oehlers, P.J.; Schaasberg, W.; Lelie, P. N.; Weiner, Amy J.; Polito, A.; Quan, Stella; Nello, R. Di; Houghton, Michael; Mulder‐Folkerts, D. K. F.; Leentvaar-Kuypers, A.

doi:10.1016/0140-6736(91)90942-i

Cited by 497 publications

(185 citation statements)

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Section: Anti-hcv Enzyme Immunoassay (Eia) Testsmentioning

confidence: 99%

“…The additional antigens c22 and c33 were derived from two conserved regions: the structural region (core) and NS3 region, respectively (Figure l). 21,22 In patients with posttransfusion NANBH, the seroconversion rate improved from 54% with the first-generation to 82% with a second-generation test and the time lag to seroconversion decreased from a mean of 6.1 weeks after the onset of hepatitis with the first-generation test to a mean of 2.3 weeks with the second-generation test.23 Thus, the second-generation test reduces the "window-phase" to seroconversion and increases the sensitivity in diagnosing HCV infection, with a dramatic reduction in the number of false-positive reactions seen with the first-generation test. Recently, third-generation anti-HCV EIA tests, which additionally detect NS5 antibodies, have been developed and are now commercially available.…”

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confidence: 99%

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Hepatitis C Virus (HCV) Infection in Saudi Arabia: A Review

Al-Faleh

Ramia

1997

Ann Saudi Med

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It is well established now that HCV is the major etiological agent of parenterally transmitted non-A, non-B hepatitis (PT-NANBH), [1][2][3] and that it has a worldwide distribution. Studies on HCV infection have led to three striking observations. First, there is a high frequency of chronic infection in a significant number of infected individuals. It is estimated that at least 50% of HCV infections lead to chronic liver disease, including chronic active hepatitis with or without concurrent cirrhosis. [4][5][6] Second, HCV has been implicated as one of the major causative agents of primary hepatocellular carcinoma (HCC) in Japan 7 , Saudi Arabia, 8 and other parts of the world. [9][10] Third, approximately 45% of HCV cases have no obvious risk factors, including parenteral exposure, 4-6 leaving unanswered the question of virus transmission via as yet unidentified routes of exposure. The aim of this article is to review the literature about the extent of HCV infection in Saudi Arabia and see what can be concluded from the studies conducted so far. However, since there have been dramatic advances in the serologic diagnosis of HCV during the past six to seven years, we would first like to briefly review those serologic tests used and their reliability in diagnosing HCV infection. Diagnosis of HCV Infection Anti-HCV enzyme immunoassay (EIA) testsHCV infection, once a diagnosis of "exclusion" based on the absence of markers of acute infection with hepatitis A virus (HAV) or hepatitis B virus (HBV) can now be specifically diagnosed by using serodiagnostic assays for virus-specific antibodies.11 A first-generation anti-HCV EIA test was developed by using recombinant c100-3, derived from the NS3/NS4 region of the genome of HCV, as antigen (Figure 1). The test was used widely and although important data was generated, the test suffered from major drawbacks. These included failure to discover all patients with HCV infection, 12 long "window-phase" before seroconversion (could be up to 12 months), 13 in addition to a high rate of false-positive reactions. [14][15][16][17][18][19][20] To circumvent the drawbacks of the anti-HCV c100-3 test, recombinant or synthetic antigens derived from other regions of the HCV genome were included in the test and this is what is referred to as second-generation anti-HCV EIA tests. The additional antigens c22 and c33 were derived from two conserved regions: the structural region (core) and NS3 region, respectively (Figure l). 21,22 In patients with posttransfusion NANBH, the seroconversion rate improved from 54% with the first-generation to 82% with a second-generation test and the time lag to seroconversion decreased from a mean of 6.1 weeks after the onset of hepatitis with the first-generation test to a mean of 2.3 weeks with the second-generation test.23 Thus, the second-generation test reduces the "window-phase" to seroconversion and increases the sensitivity in diagnosing HCV infection, with a dramatic reduction in the number of false-positive reactions seen with the first-generation ...

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Section: Anti-hcv Enzyme Immunoassay (Eia) Testsmentioning

confidence: 99%

mentioning

confidence: 99%

Hepatitis C Virus (HCV) Infection in Saudi Arabia: A Review

Al-Faleh

Ramia

1997

Ann Saudi Med

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“…Anti-HCV antibodies were screened using a secondgeneration enzyme immunoassay kit (ELISA-II, Abbott  , Chicago, IL, USA) 31 . Anti-HCV-positive sera, those providing doubtful results were tested by a second-generation recombinant immunoblot method (Ortho Diagnostic Systems Inc  , Emerville-CA, USA).…”

Section: Methodsmentioning

confidence: 99%

Very low prevalence of hepatitis C virus infection in rural communities of northeastern Brazil with a high prevalence of schistosomiasis mansoni

Tavares-Neto

Prata

Paraná

et al. 2005

Rev. Soc. Bras. Med. Trop.

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“…[3][4][5][6] Nevertheless, second-or third-generation immunoblot tests are still used for confirmation in most laboratories. 7,8 The detection of HCV antibodies in serum does not provide information on the replicative status of HCV, a parameter that can be useful in the management of infected patients. Polymerase chain reaction (PCR)-based assays have been developed and are capable of detecting minute amounts of HCV RNA in serum or plasma.…”

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confidence: 99%

What strategy should be used for diagnosis of hepatitis C virus infection in clinical laboratories?

et al. 1998

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The aim of this study was to determine a cost-effective strategy for the diagnosis of hepatitis C virus ( The diagnosis of hepatitis C virus (HCV) infection is based on the detection of anti-HCV antibodies in serum, generally by means of enzyme-linked immunosorbent assays (ELISA). Two different settings must be considered: 1) Blood banks routinely perform anti-HCV testing in blood donors to identify potentially infectious donations and to avoid posttransfusion HCV infection; 2) clinical laboratories routinely search for anti-HCV antibodies in patients with risk factors for parenterally acquired viral infections or clinical symptoms compatible with HCV infection to make appropriate clinical decisions, including therapeutic ones. By analogy with human immunodeficiency virus diagnosis, the French laws have been obliging to perform two different ELISA tests in the routine diagnosis of HCV infection in clinical laboratories for several years, while only one test was needed for blood screening.First-generation anti-HCV ELISAs were lacking sensitivity as well as specificity. This is why first-generation confirmatory assays based on immunoblot testing were developed and systematically used in samples positive in ELISA. 1,2 Since then, ELISA assays have considerably improved, and the second-or third-generation tests available today are both highly sensitive and specific. 3-6 Nevertheless, second-or third-generation immunoblot tests are still used for confirmation in most laboratories. 7,8 The detection of HCV antibodies in serum does not provide information on the replicative status of HCV, a parameter that can be useful in the management of infected patients. Polymerase chain reaction (PCR)-based assays have been developed and are capable of detecting minute amounts of HCV RNA in serum or plasma.The aim of this work was to determine whether a double ELISA determination and confirmation of positive ELISA results with immunoblot assays are still useful in clinical laboratories performing routine diagnosis of HCV infection. MATERIALS AND METHODSFrom January 1 to May 22, 1996, 3,014 consecutive requests for the detection of anti-HCV antibodies were sent to the virology laboratory by the various medical departments of our institution.The serum samples were routinely tested for the presence of anti-HCV antibodies with two different ELISAs: ORTHO HCV 3.0 ELISA Test System (ELISA3.0 HCV; Ortho Clinical Systems, Raritan, NJ), and MONOLISA anti-HCV New Ag (MONOLISA HCV; Sanofi Diagnostics Pasteur, Marnes-la-Coquette, France). ELISA 3.0 detects antibodies directed to core, nonstructural (NS) 3, NS4, and NS5 HCV antigens, while MONOLISA HCV detects antibodies directed to core, NS3, and NS4 antigens. 9 Different peptides are used in the two assays. 9 The assays were perfomed according to the manufacturers' instructions, and, in each sample, the optical density (OD) ratio was calculated by dividing the sample OD by the assay control OD. Samples with an OD ratio Ն2 were considered positive, samples with an OD ratio between 1 and 2 we...

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Confirmation of hepatitis C virus infection by new four-antigen recombinant immunoblot assay

Cited by 497 publications

References 9 publications

Hepatitis C Virus (HCV) Infection in Saudi Arabia: A Review

Hepatitis C Virus (HCV) Infection in Saudi Arabia: A Review

Very low prevalence of hepatitis C virus infection in rural communities of northeastern Brazil with a high prevalence of schistosomiasis mansoni

What strategy should be used for diagnosis of hepatitis C virus infection in clinical laboratories?

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