Real‐world utility of HCV core antigen as an alternative to HCV RNA testing: Implications for viral load and genotype

Pollock, Kevin G; McDonald, Scott; Gunson, Rory; McLeod, Allan; Went, April; Goldberg, David J.; Hutchinson, Sharon; Barclay, Stephen T.

doi:10.1111/jvh.13337

Cited by 8 publications

(5 citation statements)

References 23 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Although the low level of viremia may lead to reduced sensitivity of the HCV‐cAg assay, 26,28 several studies reported that HCV genotype 3 infection was associated with increased odds of a false‐negative result (odds ratio = 3.59, 95% CI: 1.32‐9.71), 28–30 which may be contributed by HCV core mutations (A48T and T49A/P) 31 . Moreover, HCV genotypes may affect HCV‐cAg levels; HCV 1b genotype may have higher HCV‐cAg levels than 3b, 2, and 1b/3b‐mix genotypes 29,30 .…”

Section: Discussionmentioning

confidence: 99%

The utility of HCV core antigen for evaluation of viremia at 48 weeks posttreatment with direct‐acting antivirals

Tseng

et al. 2022

Adv in Digestive Medicine

View full text Add to dashboard Cite

The hepatitis C virus core antigen (HCV‐cAg) assay is a cheap and rapid alternative to HCV‐RNA detection, while the results were limited to 12 weeks following direct‐acting antiviral (DAA) treatment. In this study we aimed to investigate the role of the HCV‐cAg assay up to 48 weeks after DAA treatment. We enrolled 98 patients with chronic HCV infection who received DAA treatment in this study. Plasma samples were assessed for HCV‐RNA (AmpliPrep/COBAS TaqMan assay, Roche) and HCV‐cAg (Abbott ARCHITECT HCV‐cAg assay) levels at baseline, 12 weeks (P12) and 48 weeks (P48) after DAA treatment. The sensitivity and specificity of HCV‐cAg were compared with those of HCV‐RNA. A total of 284 samples from 98 enrolled participants were analyzed. HCV‐cAg levels changed in parallel with HCV‐RNA levels in HCV‐infected patients during and after DAA therapy. HCV‐cAg levels showed excellent correlation with HCV viral load (R = 0.951, R2 = 0.905, β = 0.951, and P < .001). The overall sensitivity and specificity for HCV‐cAg in detecting quantifiable HCV‐RNA thresholds were 96.9% and 100%, respectively. Three patients with baseline HCV viremia had nonreactive HCV‐cAg (false‐negative rate was 1.02%); none of the patients were HCV‐cAg positive and HCV‐RNA negative. At 48 weeks after DAA treatment, the HCV‐cAg assay detected all patients with viremia, demonstrating 100% sensitivity and specificity. In conclusions, the HCV‐cAg assay has high sensitivity and specificity for the detection of pre‐ and post‐DAA treatment viremia and may be a useful tool to confirm viremia at P12 and P48.

show abstract

Section: Discussionmentioning

confidence: 99%

The utility of HCV core antigen for evaluation of viremia at 48 weeks posttreatment with direct‐acting antivirals

Tseng

et al. 2022

Adv in Digestive Medicine

View full text Add to dashboard Cite

show abstract

“…Genotype 3 has found to be associated with increased odds of a false-negative result (odds ratio(OR) = 3.59, 95% CI: 1.32-9.71), while older age (OR = 0.92, 95% CI: 0.88-0.97 per year) and VL (OR = 0.10, 95% CI: 0.05-0.21 perlog 10 IU/mL) were associated with reduced odds of a false negative. 24 Although HCV-cAg testing apply to diagnosis could lead to significant cost savings in national screening programmes, a significant proportion of HCVinfected individuals may be missed particularly in low-and middleincome regions, where genotype 3 is prevalent. These findings have implications for HCV diagnosis and determination of viral clearance after treatment.…”

Section: Hcv-cag Expression Highly Agreement With That Of Hcv-rnamentioning

confidence: 99%

HCV core antigen plays an important role in the fight against HCV as an alternative to HCV‐RNA detection

Wang

Jiang

et al. 2021

Clinical Laboratory Analysis

View full text Add to dashboard Cite

Objective: To discuss the clinical significance of HCV-cAg testing in the diagnosis, activity determination, and monitoring of therapeutic effectiveness of HCV infection and its advantages compared with HCV-RNA and anti-HCV antibodies detection. Methods:By summarizing the published literature, the advantages and significance of HCV core antigen detection were sought.Results: The expression of HCV-cAg is highly consistent with that of HCV-RNA, but compared with HCV-RNA, detection of HCV-cAg is easy to operate, time saving, and low cost. HCV-cAg can be detected within 12~15 days after infection, and the window period can be shortened by5~7 weeks. HCV-cAg is a serological indicator of virus replication, which can distinguish previous infection of HCV or current infection.HCV-cAg detection is more suitable for immunocompromised, hemodialysis, organ transplant patients. HCV-cAg also can be used to monitor antiviral efficacy and predict sustained virological response (SVR). Conclusion:HCV core antigen has similar clinical sensitivity to NAT and can be used as a substitute for HCV-RNA in the diagnosis of virus infection. Combined detection of HCV-cAg and antibody serology can help doctors detect HCV infection earlier, accurately diagnose different stages of HCV infection, and evaluate the therapeutic effect of antiviral drugs, which are beneficial in the prevention and treatment of hepatitis C.

show abstract

“…The real-world utility of HCV cAg detection as a substitute for HCV RNA confirmation to identify active infection was demonstrated in a cohort of 744 patients in a Scottish study [ 113 ]. The overall HCV cAg assay sensitivity was demonstrated to be 82.1% and the specificity was 99.8%.…”

Section: The Real-world Clinical Performance Of Current Hcv Diagnostic Algorithmsmentioning

confidence: 99%

“…Although HCV cAg has been implemented as a cost-effective single-step HCV diagnosis strategy in high-income countries in less prevalent HCV settings, a lot of HCV-positive individuals can be missed. Due to this, HCV cAg testing could be feasible for viral clearance determination after post-HCV treatment in LMICs where GT-3 is more prevalent [ 113 ].…”

Section: The Real-world Clinical Performance Of Current Hcv Diagnostic Algorithmsmentioning

confidence: 99%

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

et al. 2021

View full text Add to dashboard Cite

The simplification of current hepatitis C diagnostic algorithms and the emergence of digital diagnostic devices will be very crucial to achieving the WHO’s set goals of hepatitis C diagnosis (i.e., 90%) by 2030. From the last decade, hepatitis C diagnosis has been revolutionized by the advent and approval of state-of-the-art HCV diagnostic platforms which have been efficiently implemented in high-risk HCV populations in developed nations as well as in some low-to-middle income countries (LMICs) to identify millions of undiagnosed hepatitis C-infected individuals. Point-of-care (POC) rapid diagnostic tests (RDTs; POC-RDTs), RNA reflex testing, hepatitis C self-test assays, and dried blood spot (DBS) sample analysis have been proven their diagnostic worth in real-world clinical experiences both at centralized and decentralized diagnostic settings, in mass hepatitis C screening campaigns, and hard-to-reach aboriginal hepatitis C populations in remote areas. The present review article overviews the significance of current and emerging hepatitis C diagnostic packages to subvert the public health care burden of this ‘silent epidemic’ worldwide. We also highlight the challenges that remain to be met about the affordability, accessibility, and health system-related barriers to overcome while modulating the hepatitis C care cascade to adopt a ‘test and treat’ strategy for every hepatitis C-affected individual. We also elaborate some key measures and strategies in terms of policy and progress to be part of hepatitis C care plans to effectively link diagnosis to care cascade for rapid treatment uptake and, consequently, hepatitis C cure.

show abstract

Real‐world utility of HCV core antigen as an alternative to HCV RNA testing: Implications for viral load and genotype

Cited by 8 publications

References 23 publications

The utility of HCV core antigen for evaluation of viremia at 48 weeks posttreatment with direct‐acting antivirals

The utility of HCV core antigen for evaluation of viremia at 48 weeks posttreatment with direct‐acting antivirals

HCV core antigen plays an important role in the fight against HCV as an alternative to HCV‐RNA detection

Hepatitis C Diagnosis: Simplified Solutions, Predictive Barriers, and Future Promises

Contact Info

Product

Resources

About