Is an assay for simultaneous detection of hepatitis C virus core antigen and antibody a valuable alternative to nucleic acid testing?

Laperche, Syria; Elghouzzi, M.H.; Morel, Pascal; Asso–Bonnet, Marianne; Marrec, N. Le; Girault, A; Servant‐Delmas, Annabelle; Bouchardeau, Françoise; Deschaseaux, Marie; Piquet, Y.

doi:10.1111/j.1537-2995.2005.00648.x

Cited by 50 publications

(58 citation statements)

References 42 publications

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“…Nevertheless, these long intervals are those observed in the "real" clinical setting and in the management of HIV-infected patients. Of note, our detection delays are consistent with those previously calculated with either commercial (30 days) or so-called natural (28 days) seroconversion panels (2,10). Importantly, for a majority of patients, the combined assay became positive as early as HCV RNA detection.…”

supporting

confidence: 88%

“…The simultaneous detection of both antigen and antibody (Ab) is now commonly used for the diagnosis of human immunodeficiency virus (HIV) infection, with the result being a dramatic shortening of the so-called seronegative window and, subsequently, the earlier diagnosis of recent infection. A similar approach based on the HCV core protein and specific anti-HCV antibody detection (Monolisa HCV Ag-Ab Ultra; Bio-Rad Laboratories, Marnes-la-Coquette, France) has recently been developed for the diagnosis of hepatitis C. The overall performance of this combined assay has previously been evaluated with seroconversion panels and HCV RNA-positive HCV Ab-negative samples (2,10,11).…”

mentioning

confidence: 99%

“…The aim of this study was to complete previous evaluations of the Monolisa HCV Ag-Ab Ultra assay (2,10,11) by assessing its potential clinical benefit in the setting of acute HCV infection in HIV-infected patients.…”

mentioning

confidence: 99%

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Early Detection of Hepatitis C Virus Infection by Use of a New Combined Antigen-Antibody Detection Assay: Potential Use for High-Risk Individuals

et al. 2006

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The performance of a new combined antigen-antibody assay (Monolisa HCV Ag-Ab Ultra; Bio-Rad Laboratories) was evaluated in the context of acute hepatitis C in human immunodeficiency virus-infected patients. The combined assay became positive as early as the first PCR and earlier than a third-generation enzymelinked immunosorbent assay in 65% of the cases. Reduction of the long period of HCV seronegativity should improve the diagnosis of hepatitis C infection, especially in high-risk populations.The early diagnosis of hepatitis C virus (HCV) infection is crucial to prevent further transmission in high-risk groups and to allow clinicians to make a rapid decision about treatment, which has been proven to have a high degree of efficacy for acute hepatitis C (5). Due to the long period of seronegativity, serological assays (18) remain poorly efficient for diagnosis in the early stages of HCV infection. Strategies that can be used to improve the ability to diagnose the infection before seroconversion require additional direct tests, such as detection of viral RNA by PCR or detection of HCV core antigen (Ag). However, genomic tests, which are limited by the requirement for specific equipment, a long delay in the time to a result, the risk of contamination, and high costs, cannot be used as routine screening tools. Moreover, the assay based on detection of the HCV core protein (Trak-C; Ortho Clinical Diagnostics) (12) and proposed as an alternative to PCR (3, 19) is no longer available in several countries and suffered from a lack of sensitivity and relatively long hands-on time. The simultaneous detection of both antigen and antibody (Ab) is now commonly used for the diagnosis of human immunodeficiency virus (HIV) infection, with the result being a dramatic shortening of the so-called seronegative window and, subsequently, the earlier diagnosis of recent infection. A similar approach based on the HCV core protein and specific anti-HCV antibody detection (Monolisa HCV Ag-Ab Ultra; Bio-Rad Laboratories, Marnes-la-Coquette, France) has recently been developed for the diagnosis of hepatitis C. The overall performance of this combined assay has previously been evaluated with seroconversion panels and HCV RNA-positive HCV Ab-negative samples (2, 10, 11).In the context of HIV infection, the HCV seroconversion delay is often prolonged (16), and the failure of reactivity of current HCV Ab detection tests (9, 15) often requires PCR for HCV RNA detection. The aim of this study was to complete previous evaluations of the Monolisa HCV Ag-Ab Ultra assay (2, 10, 11) by assessing its potential clinical benefit in the setting of acute HCV infection in HIV-infected patients.Twenty HIV-infected patients were recently identified to have acute hepatitis C. These patients were among the patients in our local cohort of HIV-infected homosexual males with high-risk sexual behaviors (6). The patients had been HIV infected for 5 to 19 years, all were receiving highly active antiretroviral therapy, and for most of them, the HIV infection was well...

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confidence: 88%

mentioning

confidence: 99%

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Early Detection of Hepatitis C Virus Infection by Use of a New Combined Antigen-Antibody Detection Assay: Potential Use for High-Risk Individuals

et al. 2006

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“…First, we did not assume the treatment at cirrhosis in our model. Second, our screening strategy contained the HCV core antigen test, which has been recently recommended for use in screening because of the cheaper price and the easier performance in comparison to the HCV-PCR test (Bouvier-Alias et al 2002;Laperche et al 2005). Third, the combination therapy with peginterferon plus ribavirin has replaced interferon in combination to ribavirin which was used in their study.…”

Section: Discussionmentioning

confidence: 99%

Cost-Effectiveness of the National Screening Program for Hepatitis C Virus in the General Population and the High-Risk Groups

Nakamura

Terajima

Aoyagi

et al. 2008

Tohoku J. Exp. Med.

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In Japan, the national screening for the hepatitis C virus (HCV) has been started for both the general population and the high-risk groups. Our cost-effectiveness analysis was based on the result of the screening program including 99,001 people among the general population and 42,538 people among the high risk group from 2003 to 2006. The screening was performed using the three steps of the semi-quantitative HCV antibody test, the HCV core antigen test and the HCV-PCR test. A Markov model for HCV infected patients was constructed to estimate the future clinical benefits and the lifetime cost and the cost-effectiveness analysis was performed considering the recent treatment with peginterferon plus ribavirin. In the cost-effectiveness analysis, the cohort, in which the screening was implemented (= screening strategy), was compared with the similar cohort without the screening (= no-screening strategy) in both the general population and the high-risk group, stratified by age. The infection rates of the general population and the high-risk group were 0.36% and 0.81%, respectively. The incremental cost-effectiveness ratio (ICER), a measure of cost-effectiveness, of the general population and the high-risk group was calculated to be from 848 to 4,825 and -749 to 2,297 $/life expectancy gained, respectively. The treatment effectiveness, transition probabilities and the infection rate varied in the one-way sensitivity analyses, but the superiority of the screening strategy regarding the cost-effectiveness was unchanged. In conclusion, the screening strategy in both the general population and the high-risk group therefore appears to be more cost-effective than a no-screening strategy.screening; hepatitis C; general population; high risk group; cost-effectiveness. Tohoku

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“…A fourth-generation assay was reactive a mean of 21.6-26.0 days before thirdgeneration assays. 186,187 Fourth-generation assays were reactive a mean of 4.8-30.0 days after NAT. 187,188 One study reported a turnaround time of 190 minutes to perform the test.…”

Section: Hcv Fourth-generation Immunoassays This Reviewmentioning

confidence: 99%

PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission through Organ Transplantation

et al. 2013

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Is an assay for simultaneous detection of hepatitis C virus core antigen and antibody a valuable alternative to nucleic acid testing?

Cited by 50 publications

References 42 publications

Early Detection of Hepatitis C Virus Infection by Use of a New Combined Antigen-Antibody Detection Assay: Potential Use for High-Risk Individuals

Early Detection of Hepatitis C Virus Infection by Use of a New Combined Antigen-Antibody Detection Assay: Potential Use for High-Risk Individuals

Cost-Effectiveness of the National Screening Program for Hepatitis C Virus in the General Population and the High-Risk Groups

PHS Guideline for Reducing Human Immunodeficiency Virus, Hepatitis B Virus, and Hepatitis C Virus Transmission through Organ Transplantation

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