Evaluation of a total hepatitis C virus (HCV) core antigen assay for the detection of antigenaemia in anti‐HCV positive individuals

Valcavi, P.; Medici, Maria Cristina; Casula, F.; Arcangeletti, Maria Cristina; Pinardi, Federica; Calderaro, Adriana; Chezzi, Carlo; Dettori, G.

doi:10.1002/jmv.20105

Cited by 25 publications

(16 citation statements)

References 23 publications

(23 reference statements)

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“…To the best of our knowledge, five studies evaluated the usefulness of HCV core antigen as a marker of active/ongoing HCV infection in the therapynaïve patients [Cano et al, 2003;Agha et al, 2004;Krajden et al, 2004;Netski et al, 2004;Valcavi et al, 2004]. These studies reported on HCV RNA positive samples from 114 to 348 and showed the OTCA to be 86.9-97.4% as sensitive as NAT.…”

Section: Discussionmentioning

confidence: 94%

“…Thus, the detection in the present study of one sample that was ''RNA negative/core antigen positive'' (Table I) might be explained if the detection of HCV core antigen and RNA were correlated to the detection of hepatitis B e antigen (HBeAg) and hepatitis B DNA. In this instance, not all the HBeAg positive patients may express high levels of HBV DNA and conversely, the absence of HBeAg may not indicate the absence of infectivity [Valcavi et al, 2004]. Further work is required to understand the full dynamics and relationships of these two HCV markers.…”

Section: Discussionmentioning

confidence: 97%

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Evaluation of a total core antigen assay for the diagnosis of hepatitis C virus infection in hemodialysis patients

et al. 2005

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Hemodialysis patients are recognized as a group at high risk of infection with hepatitis C virus (HCV). Therefore, such a population should be screened routinely for the presence of HCV viremia. Since nucleic acid techniques remain expensive and largely unavailable in many laboratories in the developing world, the present study assesses the clinical usefulness of the HCV core antigen enzyme immunoassay for the diagnosis of HCV infection in dialysis patients. One hundred seventy-five dialysis patients were screened for the presence of anti-HCV antibodies and HCV RNA in the serum. One hundred twenty-eight serum samples were collected from the 76 patients who were anti-HCV antibody- and/or HCV RNA-positive. These were evaluated for total HCV core antigen. Of these samples, 55 had sufficient volume to be further tested to quantify HCV RNA by reverse transcription polymerase chain reaction (RT-PCR). Genotyping of the HCV strains showed that the majority belonged to genotype 1b (77%). The HCV core antigen assay showed a sensitivity and specificity of 84% and 89%, respectively. The use of core antigen assay has enabled the early detection of three patients who developed an acute hepatitis C infection during the period of study. A correlation study was undertaken between the quantitative values of viral load, expressed as pg/ml of HCV core antigen in serum, and viral RNA in UI/ml. A significant correlation was observed (Pearson's correlation coefficient: 0.552; P<0.001). In conclusion, detection of HCV core antigen in serum is an inexpensive, reliable, and highly specific assay that can be useful in most laboratory settings to diagnose HCV infection, and especially in laboratories where nucleic acid technologies are not yet available.

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Section: Discussionmentioning

confidence: 94%

Section: Discussionmentioning

confidence: 97%

Evaluation of a total core antigen assay for the diagnosis of hepatitis C virus infection in hemodialysis patients

et al. 2005

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“…Qualitative and quantitative ELISA kit (Ortho-Clinical Diagnostics, Johnson & Johnson Company) have been successively developed for assessment of HCV core antigen and commercially available out of China, such as in Thailand and Italy, to detect HCV core antigen [19,20] . A number of reports have suggested that these assays could be used to reduce the serological preseroconversion window period, measure HCV replication, and monitor the response to antiviral therapy [21][22][23] .…”

Section: Discussionmentioning

confidence: 99%

Detection of hepatitis C virus core antigen for early diagnosis of hepatitis C virus infection in plasma donor in China

Zhang¹,

Li²,

Wang³

et al. 2007

WJG

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AIM:To evaluate the efficacy of a new hepatitis C virus (HCV) core antigen assay developed in China. METHODS:After the determination of HCV infection, 49 serial samples were selected from 11 regular plasma donors in 5 different plasma stations. To compare the performance of HCV core antigen detection and HCV PCR, these samples were genotyped, and each specimen was analyzed by ELISA for the detection of HCV core antigen and by qualitative HCV PCR. RESULTS:Among all of the sequential samples, the original 13 specimens were HCV RNA-negative, and 36 samples were HCV RNA-positive. Twenty-seven samples (75%) were HCV core antigen-positive from these HCV RNA-positive specimens. Conversely, 27 samples (93.1%) were found HCV RNA-positive in HCV core antigenpositive samples. Intervals between HCV RNA and HCV core antigen-positive, as well as between HCV core antigen-positive and HCV antibody-positive were 36.0 and 32.8 d, respectively. CONCLUSION:This HCV core antigen assay, developed in China, is able to detect much of anti-HCV-negative, HCV RNA-positive preseroconversion window period (PWP) plasma donations.

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“…As previously published (1), the testing for the presence of anti-HCV antibody is still recommended for the initial identification of HCV infection in the general population. In anti-HCV EIA-positive subjects, the HCV core Ag assay and other serological tools, such as RIBA and ALT level testing (19), will contribute to establishing the diagnosis of an ongoing HCV infection.…”

Section: Discussionmentioning

confidence: 99%

Usefulness of the Hepatitis C Virus Core Antigen Assay for Screening of a Population Undergoing Routine Medical Checkup

et al. 2005

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We studied the usefulness of the recently designed Trak-C assay for the detection and quantification of the hepatitis C virus (HCV) core antigen (Ag) for the screening of HCV infection in 4,201 subjects selected from 74,150 consecutive volunteers undergoing routine medical checkups. Subjects were selected for screening because they had risk factors (group II, n ‫؍‬ 321) and/or elevated alanine transaminase activity (group I, n ‫؍‬ 3847). Initially, the anti-HCV antibody assay and the Trak-C assay were performed on each patient. Subsequently, the Trak-C assay was performed only when the anti-HCV enzyme immune assay (EIA) was positive. Positive samples were further evaluated for anti-HCV antibodies by a third-generation strip immunoblot assay and for HCV RNA. Four samples (1.2%) from group II and 113 (2.9%) from group I were anti-HCV EIA positive. We also tested 33 subjects who previously tested positive for anti-HCV in our medical center. Among the 150 anti-HCV EIA-positive samples, the HCV core Ag result was in accord with the HCV RNA result in 146 cases (97.3%). When the EIA result was positive, the HCV core Ag concentration and the HCV RNA load were correlated (r 2 ‫؍‬ 0.78; P < 0.001). Four samples with low viral loads were Trak-C negative but HCV RNA positive. Among the 2,395 anti-HCV EIA-negative serum samples collected during the first part of the study, 17 (0.7%) were found to contain very low levels of HCV core Ag (<8.5 pg/ml, the cutoff value being 1.5 pg/ml). All these samples were HCV RNA negative and considered to be false positives. This was confirmed by HCV core Ag neutralization analysis. The HCV core Ag assay is a useful method in the screening strategy of HCV infection and provides a reliable means of distinguishing between current and cleared HCV infections that is well correlated with HCV RNA testing.The method currently recommended for identifying subjects with hepatitis C virus (HCV) infection is an enzyme immune assay (EIA) for the detection of anti-HCV antibodies (16). However, this assay sometimes generates false-positive or false-negative results. Furthermore, it is not always possible to distinguish between current and past cleared infections. Thus, supplementary tests are required. The strip immunoblot assay, a more specific anti-HCV serological test, is useful to distinguish true-positive from false-positive EIA results. Positive results from nucleic acid testing (NAT) for HCV RNA indicate active HCV infection (1). Assays that detect the HCV core antigen (Ag) have been developed to diagnose current HCV infection. The first such assay developed was a qualitative assay, conceived for screening blood donations. This assay increased viral safety by significantly reducing the length of the window preceding seroconversion (4, 13). A second test was subsequently developed for the detection and quantification of total HCV core antigen (Trak-C; Ortho-Clinical Diagnostics, Raritan, N.J.). This assay, incorporating an immune complex dissociation step, was designed for blood donation screening (3...

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Evaluation of a total hepatitis C virus (HCV) core antigen assay for the detection of antigenaemia in anti‐HCV positive individuals

Cited by 25 publications

References 23 publications

Evaluation of a total core antigen assay for the diagnosis of hepatitis C virus infection in hemodialysis patients

Evaluation of a total core antigen assay for the diagnosis of hepatitis C virus infection in hemodialysis patients

Detection of hepatitis C virus core antigen for early diagnosis of hepatitis C virus infection in plasma donor in China

Usefulness of the Hepatitis C Virus Core Antigen Assay for Screening of a Population Undergoing Routine Medical Checkup

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