False-positive hepatitis C virus antibody tests in paraproteinaemia

Boudart, D.; Lucas, J.; Muller, Jean‐Yves; Carrer, D. Le; Planchon, B.; Harousseau, Jean‐Luc

doi:10.1016/0140-6736(90)91585-x

Cited by 61 publications

(14 citation statements)

References 1 publication

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…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).…”

Section: Anti-hcv Enzyme Immunoassay (Eia) Testsmentioning

confidence: 99%

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

Al-Faleh

Ramia

1997

Ann Saudi Med

View full text Add to dashboard Cite

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 ...

show abstract

Section: Anti-hcv Enzyme Immunoassay (Eia) Testsmentioning

confidence: 99%

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

Al-Faleh

Ramia

1997

Ann Saudi Med

View full text Add to dashboard Cite

show abstract

“…Initial studies using as antigen this fusion protein, designated C100-3, confirmed HCV as the predominant agent of NANBH (4)(5)(6)(7). However, these and subsequent studies (8)(9)(10)(11)(12) have shown a number of shortcomings with C100-3-based serological tests, resulting from insufficient sensitivity and specificity.…”

mentioning

confidence: 99%

Improved serodiagnosis of hepatitis C virus infection with synthetic peptide antigen from capsid protein.

Hosein

Fang

Popovsky

et al. 1991

Proc. Natl. Acad. Sci. U.S.A.

141

View full text Add to dashboard Cite

Cloning and expression of hepatitis C virus have allowed the development of immunoassays to detect hepatitis C virus infection. However, currently available recombinant fusion protein C100-3 assays, based on a nonstructural protein of the virus, are limited in sensitivity, particularly for detecting acute infection. In this report seroconversion panels showed that an assay based on synthetic peptides, derived from immunodominant regions of both capsid and nonstructural proteins, accelerated hepatitis C virus antibody detection by 4-10 weeks. In screening, this enzyme immunoassay increased detection from 47% to 64% in plasmapheresis donors with elevated alanine aminotransferase levels (>100 international units per liter), from 15% to 24% in anti-hepatitis B core antigen-positive blood donors, and from 28% to 42% in renal dialysis patients when compared with nonstructural peptide-based assays. The screening assay was repeatedly reactive for 27 of 2902 volunteer blood donor samples (0.93%); four sera reacted only with the capsid antigen. The peptide test distinguished true from false positive results in agreement with recombinant immunoblot assay in 96% of blood donor samples repeatably reactive on a recombinant hepatitis C virus enzyme immunoassay.

show abstract

“…Serial testing of 6 patients showed that anti-HCV positivity disappeared with successful immunosuppressive therapy [7]. False-positive anti-HCV ELISA results were similarly reported in patients with rheumatoid arthritis [8], paraproteinemia [9] and primary biliary cirrhosis [10], although at a much lower frequency than in sera from patients with AIH. It had previously been reported that the presence of large immune complexes in sera of patients with AIH caused difficulties in other immunoassays probably explaining the high rates of false-positive results in anti-HCV ELISAs [11].…”

mentioning

confidence: 68%