The accuracy and cost‐effectiveness of hepatitis C core antigen assay in the monitoring of anti‐viral therapy in patients with chronic hepatitis C genotype 4

Kamal, Sanaa M.; Kassim, Samar K.; Gohary, Eman El; Fouad, Ahmed; Nabegh, Leila; Hafez, Tamer; Bahnasy, Khaled; Hassan, H.; Ghoraba, Dalia

doi:10.1111/apt.13261

Cited by 20 publications

(22 citation statements)

References 38 publications

(63 reference statements)

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“…Cost of testing to the patient or health care provider is also a key factor for implementation in LMICs. The cost estimates from LMICs are highly variable and often country specific, though generally cost estimates for HCVcAg tests are lower (from $10–50) than for HCV RNA tests ($13–100) (65, 70, 72, 73) (unpublished survey of high burden countries by Foundation for Innovative New Diagnostics and WHO).…”

Section: Discussionmentioning

confidence: 99%

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Freiman¹,

Tran²,

Schumacher³

et al. 2016

Ann Intern Med

150

145

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Background Diagnosis of chronic Hepatitis C Virus (HCV) infection requires both a positive HCV antibody screen and confirmatory nucleic acid test (NAT). HCV core antigen (HCVcAg) is a potential alternative to NAT. Purpose This systematic review evaluated the accuracy of diagnosis of active HCV infection among adults and children for five HCVcAg tests compared to NAT. Data Sources EMBASE, PubMed, Web of Science, Scopus, and Cochrane from 1990 through March 31, 2016. Study Selection Cohort, cross-sectional, and randomized controlled trials were included without language restriction Data Extraction Two independent reviewers extracted data and assessed quality using an adapted Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool. Data Synthesis 44 studies evaluated 5 index tests. Studies for the ARCHITECT had the highest quality, while those for Ortho ELISA were the lowest. From bivariate analyses, the sensitivity and specificity with 95% CI were: ARCHITECT 93.4% (90.1, 96.4) and 98.8% (97.4, 99.5), Ortho ELISA 93.2% (81.6, 97.7) and 99.2% (87.9, 100), and Hunan Jynda 59.5% (46.0, 71.7) and 82.9% (58.6, 94.3). Insufficient data were available for a meta-analysis for Lumipulse and Lumispot. In three quantitative studies using ARCHITECT, HCVcAg correlated closely with HCV RNA above 3000 IU/mL. Limitations There was insufficient data on covariates such as HIV or HBV status for sub-group analyses. Few studies reported genotypes of isolates and there were scant data for genotypes 4, 5, and 6. Most studies were conducted in high resource settings within reference laboratories. Conclusions HCVcAg assays with signal amplification have high sensitivity, high specificity, and good correlation with HCV RNA above 3000 IU/mL. HCVcAg assays have the potential to replace NAT in high HCV prevalence settings.

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Section: Discussionmentioning

confidence: 99%

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Freiman¹,

Tran²,

Schumacher³

et al. 2016

Ann Intern Med

150

145

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“…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%

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: Introductionmentioning

confidence: 99%

“…HCV Ag has been proposed as an indirect marker of viral replication, and ELISAs have been introduced to test serum HCV Ag since 1999 . In recent years, assays for HCV Ag have been developed, such as enzyme immunoassays (EIAs) or chemiluminescent immunoassays (CMIA) . Previous studies showed that the limit of detection of HCV Ag using CMIA is approximately 0.06 pg/mL (or 3 fmol/L), which corresponds to a viral load range of 428‐2700 IU/mL; in addition, there is an excellent correlation between HCV Ag concentrations and HCV RNA levels .…”

Section: Introductionmentioning

confidence: 99%

“…In recent years, assays for HCV Ag have been developed, such as enzyme immunoassays (EIAs) or chemiluminescent immunoassays (CMIA) . Previous studies showed that the limit of detection of HCV Ag using CMIA is approximately 0.06 pg/mL (or 3 fmol/L), which corresponds to a viral load range of 428‐2700 IU/mL; in addition, there is an excellent correlation between HCV Ag concentrations and HCV RNA levels . With high analytical sensitivity and a short turn‐around time, the quantificationation of HCV Ag by means of CMIA has been suggested as an alternative to HCV RNA testing in the diagnosis and treatment monitoring of HCV infections .…”

Section: Introductionmentioning

confidence: 99%

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Utility of enzyme‐linked immunosorbent assays to test core antigen in the diagnosis and antiviral therapy management of hepatitis C virus infections

Wang

Chen

et al. 2017

Journal of Medical Virology

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In this study, we evaluate the performance of the enzyme-linked immunosorbent assays (ELISAs) for HCV Ag detection in the diagnosis and antiviral therapy management of HCV infections. For the diagnosis of an active HCV infection, the limit of detection of HCV Ag corresponding to HCV RNA level was approximately 7300 IU/mL; the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of HCV-Ag were 88.96, 100, 100, and 91.33%, respectively. The Pearson's correlation coefficient between HCV Ag and HCV RNA was 0.891. All patients with negative HCV Ag at interferon-α2α/ribavirin therapy week 1 achieved a sustained viral response (SVR), and the PPV was 100%; whereas in patients with positive HCV Ag at therapy weeks 12, the NPV for achieving non-response (NR) was 100%. The results showed that ELISAs for HCV Ag detection could be cost effectively applied to diagnose and evaluate the response to antiviral therapy for HCV infections.

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The accuracy and cost‐effectiveness of hepatitis C core antigen assay in the monitoring of anti‐viral therapy in patients with chronic hepatitis C genotype 4

Abstract: SUMMARY BackgroundQuantitative hepatitis C (HCV) polymerase chain reaction (qtHCV-PCR), the gold standard for monitoring HCV therapy, is an expensive, time-consuming procedure that requires equipped laboratories and trained personnel.

Cited by 20 publications

References 38 publications

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

Hepatitis C Core Antigen Testing for Diagnosis of Hepatitis C Virus Infection

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

Utility of enzyme‐linked immunosorbent assays to test core antigen in the diagnosis and antiviral therapy management of hepatitis C virus infections

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