A new sensitive and automated chemiluminescent microparticle immunoassay for quantitative determination of hepatitis C virus core antigen

Morota, Kaori; Fujinami, Ryo; Kinukawa, Hideki; Machida, Taiji; Ohno, Kenichi; Saegusa, Haruhisa; Takeda, Katsumichi

doi:10.1016/j.jviromet.2008.12.009

Cited by 119 publications

(141 citation statements)

References 21 publications

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“…HCV viral RNA real-time PCR, together with a HCVcoreAg assay can serve as strong evidence for predicting or excluding a HCV infection. Moreover, as some reported studies have shown, HCVcoreAg can be detected earlier than the anti-HCV antibodies produced by an individual (30). This may have implications for the newborns with maternal HCV antibodies against HCV.…”

Section: Discussionmentioning

confidence: 82%

Evaluation of Hepatitis C Virus Infection in Antibody Positive Orphan Newborns

Ziyaeyan

Jamalidoust

Moeini

2012

Jundishapur J Microbiol

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Comparing diagnostic methods of vertical transmission of HCV infection can serve as a cornerstone for better understanding of the capability of each methods in more accurate diagnosis of HCV infection in the newborns.HCV is spread through contaminated blood and blood products with percutaneous exposure. This disease also poses a risk to injection drug users (IDU) and hemodialysis patients. However, sexual transmission of HCV is comparably low in Iran, and in addition the risk through occupational exposure is also very low. Mother-to-infant transmission rates vary widely (5-9). Usually, a mother BackgroundHepatitis C virus (HCV) infection is a major cause of; chronic hepatitis, liver cirrhosis and liver cancer. It represents an enormous global health problem, affecting 130-170 million people worldwide. In Iran, the prevalence of HCV in the general population is 0.5% (1), but the rate is higher in certain at risk populations (2-4).Background: The rate of mother-to-infant hepatitis C virus (HCV) transmission is relatively low, however, this mode of infection is the most important route for childhood HCV involvement. The chances of transmission are increased by the level of maternal HCV viraemia and maternal human immunodeficiency virus (HIV) co infection. Objectives: The objective of the present study was to determine the presence of HCV infection in orphan newborns of infected mothers. Patients and Methods: A total of 29, two to seven month old, orphan infants were included in the study. The tests performed consisted of the detection of; anti-HCV and anti-HIV antibodies, HCV RNA in the plasma and peripheral blood mononuclear cells by realtime polymerase chain reaction (PCR), and finally the detection of HCV core antigens (HCV core Ag). Results: Anti-HCV antibodies were detectable in all of the infants. However HCV RNA was undetectable in both plasma and peripheral blood mononuclear cells (PBMCs) and there were also no anti-HIV 1/2 antibodies present in the infants. Conclusions: Few studies have addressed the issue of mother-to-infant transmission of HCV among orphan newborns. According to the present study, carried out with orphan babies, the use of a HCV core Ag assay and evaluation of HCV RNA in PBMCs together with HCV RNA real-time PCR on the plasma, could benefit the prediction or exclusion of HCV transmission from mother to child.

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Section: Discussionmentioning

confidence: 82%

Evaluation of Hepatitis C Virus Infection in Antibody Positive Orphan Newborns

Ziyaeyan

Jamalidoust

Moeini

2012

Jundishapur J Microbiol

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“…If both retest values indicate that the specimen is nonreactive, the specimen is considered nonreactive for HCV Ag. If one or both of the duplicates have values of Ն3.00 fmol/liter, the specimen is considered repeatedly reactive (16,23).…”

Section: Methodsmentioning

confidence: 99%

“…Therefore, these anti-HCV assays are not often used in developing countries or in routine diagnostic laboratory procedures (10). The HCV RNA assay is a reliable method but needs technical skill and may also result in false positivity because of contamination, and it is time intensive and more expensive (16).…”

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confidence: 99%

Comparison of a Newly Developed Automated and Quantitative Hepatitis C Virus (HCV) Core Antigen Test with the HCV RNA Assay for Clinical Usefulness in Confirming Anti-HCV Results

et al. 2011

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Hepatitis C virus (HCV) is a global health care problem. Diagnosis of HCV infection is mainly based on the detection of anti-HCV antibodies as a screening test with serum samples. Recombinant immunoblot assays are used as supplemental tests and for the final detection and quantification of HCV RNA in confirmatory tests. In this study, we aimed to compare the HCV core antigen test with the HCV RNA assay for confirming anti-HCV results to determine whether the HCV core antigen test may be used as an alternative confirmatory test to the HCV RNA test and to assess the diagnostic values of the total HCV core antigen test by determining the diagnostic specificity and sensitivity rates compared with the HCV RNA test. Sera from a total of 212 treatment-naive patients were analyzed for anti-HCV and HCV core antigen both with the Abbott Architect test and with the molecular HCV RNA assay consisting of a reverse transcription-PCR method as a confirmatory test. The diagnostic sensitivity, specificity, and positive and negative predictive values of the HCV core antigen assay compared to the HCV RNA test were 96.3%, 100%, 100%, and 89.7%, respectively. The levels of HCV core antigen showed a good correlation with those from the HCV RNA quantification (r ‫؍‬ 0.907). In conclusion, the Architect HCV antigen assay is highly specific, sensitive, reliable, easy to perform, reproducible, cost-effective, and applicable as a screening, supplemental, and preconfirmatory test for anti-HCV assays used in laboratory procedures for the diagnosis of hepatitis C virus infection.

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“…Thus, due to cheap and easyto-perform, the HCV core antigen quantification assay can be used as an alternative method to NATs to detect HCV RNA [44] . Currently, core antigen detection by means of a chemiluminescent microparticle immunoassay can be fully automated in the Architect HCV Core antigen test (Abbott Laboratories) [63] . The Architect HCV Ag assay had a specificity of 100%, with a lower limit of detection of 3 fmol/L corresponds to approximately 1000 IU/mL of HCV RNA [62] .…”

Section: Detection Of Viral Rnamentioning

confidence: 99%

Hepatitis C virus: Virology, diagnosis and treatment

2015

WJH

163

114

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More than twenty years of study has provided a better understanding of hepatitis C virus (HCV) life cycle, including the general properties of viral RNA and proteins. This effort facilitates the development of sensitive diagnostic tools and effective antiviral treatments. At present, serologic screening test is recommended to perform on individuals in the high risk groups and nucleic acid tests are recommended to confirm the active HCV infections. Quantization and genotyping of HCV RNAs are important to determine the optimal duration of anti-viral therapy and predict the likelihood of response. In the early 2000s, pegylated interferon plus ribavirin became the standard anti-HCV treatment. However, this therapy is not ideal. To 2014, boceprevir, telaprevir, simeprevir, sofosbuvir and Harvoni are approved by Food and Drug Administration for the treat of HCV infections. It is likely that the new all-oral, interferon-free, pan-genotyping anti-HCV therapy will be available within the next few years. Majority of HCV infections will be cured by these antiviral treatments. However, not all patients are expected to be cured due to viral resistance and the high cost of antiviral treatments. Thus, an efficient prophylactic vaccine will be the next challenge in the fight against HCV infection. Core tip: Understanding the general properties of hepatitis C virus (HCV) viral RNA and proteins facilitates the development of sensitive diagnostic tools and effective antiviral treatments. At present, serologic screening test is recommended to perform on individuals in the high risk groups and nucleic acid tests are recommended to confirm the active HCV infections. To 2014, in addition to pegylated interferon and ribavirin, boceprevir, telaprevir, simeprevir, sofosbuvir and Harvoni are approved by Food and Drug Administration to treat HCV infections. The majority of HCV infections can be cured by these anti-viral treatments. An efficient prophylactic vaccine will be the next challenge in the fight against HCV infection. REVIEWSubmit a

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A new sensitive and automated chemiluminescent microparticle immunoassay for quantitative determination of hepatitis C virus core antigen

Cited by 119 publications

References 21 publications

Evaluation of Hepatitis C Virus Infection in Antibody Positive Orphan Newborns

Evaluation of Hepatitis C Virus Infection in Antibody Positive Orphan Newborns

Comparison of a Newly Developed Automated and Quantitative Hepatitis C Virus (HCV) Core Antigen Test with the HCV RNA Assay for Clinical Usefulness in Confirming Anti-HCV Results

Hepatitis C virus: Virology, diagnosis and treatment

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