Hepatitis C virus core antigen: Analytical performances, correlation with viremia and potential applications of a quantitative, automated immunoassay

Medici, Maria Cristina; Furlini, G.; Rodella, Anna; Fuertes, A; Monachetti, Alessia; Calderaro, Adriana; Galli, S.; Terlenghi, Luigina; Olivares, Magdalena; Bagnarelli, Patrizia; Costantini, Andrea; Conto, Flora De; Sainz, Marìa; Galli, Claudio; Manca, N.; Landini, Maria Paola; Dettori, G.; Chezzi, Carlo

doi:10.1016/j.jcv.2011.05.003

Cited by 83 publications

(97 citation statements)

References 35 publications

(51 reference statements)

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“…This study also supports previous studies indicating a qualitative assay is likely to reliably identify the absence of HCV infection and confirm cure, regardless of the treatment regimen [10,13]. Our study demonstrates a similar HCVcAg analytical sensitivity (94% at baseline) to previous studies (91-98%) [10,[26][27][28] for detection of active HCV infection. With regard to on-treatment monitoring, HCV RNA detectable samples with negative HCVcAg at week 4 had declining HCV RNA levels of < 2,909 IU/mL.…”

Section: Journal Of Clinical Virology 92 (2017) 32-38supporting

confidence: 89%

“…This would have the additional advantage of improving detection of acute HCV infection cases prior to anti-HCV antibody seroconversion. In such a setting HCVcAg is a cost effective-effective strategy to replace HCV antibody as a single diagnostic assay for active infection [22,26,36]. For screening HCV in low prevalence setting, a three step algorithm with HCV antibody, followed by HCVcAg (for HCV ab reactive result) and finally HCV RNA test (for HCVcAg non-reactive result) would be cost effective in achieving 100% detection of active viraemia as previously described [37].…”

Section: Journal Of Clinical Virology 92 (2017) 32-38mentioning

confidence: 98%

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Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Lamoury¹,

Soker²,

Martinez³

et al. 2016

Journal of Hepatology

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Background: Simple, affordable diagnostic tools are essential to facilitate global hepatitis C virus (HCV) elimination efforts. Objectives: This study evaluated the clinical performance of core antigen (HCVcAg) assay from plasma samples to monitor HCV treatment efficacy and HCV viral recurrence. Study design: Plasma samples from a study of response-guided pegylated-interferon/ribavirin therapy for people who inject drugs with chronic HCV genotype 2/3 infection were assessed for HCV RNA (AmpliPrep/COBAS Taqman assay, Roche) and HCVcAg (ARCHITECT HCV Ag, Abbott Diagnostics) during and after therapy. The sensitivity and specificity of the HCVcAg assay was compared to the HCV RNA assay (gold standard). Results: A total of 335 samples from 92 enrolled participants were assessed (mean 4 time-points per participant). At baseline, end of treatment response (ETR) and sustained virological response (SVR) visits, the sensitivity of the HCVcAg assay with quantifiable HCV RNA threshold was 94% (95% CI: 88%, 98%), 56% (21%, 86%) and 100%, respectively. The specificity was between 98 to 100% for all time-points assessed. HCVcAg accurately detected all six participants with viral recurrence, demonstrating 100% sensitivity and specificity. One participant with detectable (non-quantifiable) HCV RNA and non-reactive HCVcAg at SVR12 subsequently cleared HCV RNA at SVR24. Conclusions: HCVcAg demonstrated high sensitivity and specificity for detection of pre-treatment and posttreatment viraemia. This study indicates that confirmation of active HCV infection, including recurrent viraemia, by HCVcAg is possible. Reduced on-treatment sensitivity of HCVcAg may be a clinical advantage given the moves toward simplification of monitoring schedules.

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Section: Journal Of Clinical Virology 92 (2017) 32-38supporting

confidence: 89%

Section: Journal Of Clinical Virology 92 (2017) 32-38mentioning

confidence: 98%

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Lamoury¹,

Soker²,

Martinez³

et al. 2016

Journal of Hepatology

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“…Several other studies using HCVcAg testing reported a significant correlation between serum levels of HCV-RNA and HCVcAg with different linear regression coefficients ranging from 0.6 to 0.8 (22,24,36,30−33), which is higher than seen in our study. In addition, the weak correlation reported in our study is lower than that reported elsewhere among those infected with HCV genotype 4 or other genotypes (9)(10)(11)34,35). This could be attributed to viral genetic differences and/or patient characteristics.…”

Section: Discussioncontrasting

confidence: 96%

Correlation between hepatitis C viral load and hepatitis C Core antigenaemia among Egyptians

Kotb

Esmail

Abdelwahab

et al. 2017

East Mediterr Health J

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Hepatitis C virus (HCV) infection is widespread in Egypt.This study compared HCV RNA with HCVcAg for the detection and quantification of viraemia among a sample of Egyptians. Sera from 80 suspected HCVpositive individuals were tested simultaneously for HCV-RNA load using real-time polymerase chain reaction (PCR) and HCVcAg level using ELISA. Of the 80 samples, 25% were HCV-RNA-negative. HCVcAg was detected in all samples: range 0.4-2462 ng/mL, mean 460 (SD 506) ng/mL. The sensitivity and specificity of HCVcAg were 96.7% and 90.9%, respectively. There was a significant correlation between serum HCV-RNA and HCVcAg levels (r = 0.4, P < 0.0001). HCV-RNA remains the gold standard for diagnosis of active HCV infection but HCVcAg can be used where PCR is not available. L'ARN du VHC demeure la méthode de référence pour le diagnostic d'infection à VHC active mais l'antigène de la nucléocapside peut être utilisé lorsque la PCR n'est pas disponible.‫املتوسط‬ ‫لرشق‬ ‫الصحية‬ ‫املجلة‬ ‫العرشون‬ ‫و‬ ‫الثالث‬ ‫املجلد‬ ‫الرابع‬ ‫العدد‬ 281

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“…This is clear evidence of the enhanced ability of the new HCV core Ag test compared to older ELISA, to detect low level viremia and this in accordance with Medici et al [12], who studied 193 HCV RNA low positive samples (<3.9 log10 IU/mL), HCV-Ag was detected in low levels (median 16 fmol/L) in 81.9% of studied samples and the sensitivity of HCV-Ag corresponded to 1000 IU/mL of HCV RNA and also in agreement with Emilia et al [13]. Who demonstrated sensitivity in clinical specimen's equivalent to 1200 IU/mL, corresponding to the serum with the lowest HCV RNA that tested positive for HCV-Ag.…”

Section: Discussionsupporting

confidence: 87%

“…On the other hand Medici et al [12]. Concluded that the correlation coefficient between HCV-Ag and bDNA was 0.713 and this could be explained by that these results were based on calculations with absolute and not logarithmically transformed values.…”

Section: Discussionmentioning

confidence: 96%

The Utility of Automated HCV Core Antigen Assay as an Alternative to PCR in Chronic HCV Egyptian Patients

El-reheem¹,

Fouad²,

El-Bab³

et al. 2016

J Mol Biomark Diagn

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Hepatitis C virus core antigen: Analytical performances, correlation with viremia and potential applications of a quantitative, automated immunoassay

Cited by 83 publications

References 35 publications

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Hepatitis C Virus Core Antigen: A Simplified Treatment Monitoring Tool, including for Post-Treatment Relapse

Correlation between hepatitis C viral load and hepatitis C Core antigenaemia among Egyptians

The Utility of Automated HCV Core Antigen Assay as an Alternative to PCR in Chronic HCV Egyptian Patients

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