Performance comparison of new generation HCV core antigen test versus HCV RNA test in management of hepatitis C virus infection

Çetiner, Salih; Duran, Alev Çetin; Kibar, Filiz; Yaman, Akgün

doi:10.1016/j.transci.2017.02.005

Cited by 12 publications

(21 citation statements)

References 27 publications

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“…Our results indicate excellent diagnostic performance and concordance for detecting HCVcAg in plasma when compared to HCV RNA with a sensitivity of 98.1% (95% CI: 90%‐100%) and specificity of 100% (95% CI: 93%‐100%). This is comparable to previous studies; in a bivariate analysis by Freiman et al the pooled sensitivity was 93.4% (95% CI: 90.1%‐96.4%) and pooled specificity was 98.8% (95% CI: 90.1%‐96.4%) and a retrospective large screening cohort by Van Tilborg et al demonstrated a sensitivity of 94% (95% CI: 86‐98) with a specificity of 100% (95% CI: 94%‐100%) . Our data build on previous recommendations for HCVcAg as an alternative to HCV nucleic acid testing (NAT) for determining active infection …”

Section: Discussionsupporting

confidence: 91%

“…Studies in plasma and serum have shown advantages of HCV core antigen assays over viral molecular testing methods, including (a) improved affordability; (b) rapid detection (30 minutes); (c) single platform reflex testing to allow for screening and confirmation; (d) multi‐analyte testing from one sample with a smaller input volume requirement and (e) sample stability at room temperature, reducing the need for cold chain transportation . HCV core antigen also offers the potential to provide an alternative tool for monitoring treatment and post‐treatment relapse …”

Section: Introductionmentioning

confidence: 99%

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Evaluation of a hepatitis C virus core antigen assay from venepuncture and dried blood spot collected samples: A cohort study

Catlett

Lamoury

Bajis

et al. 2019

Journal of Viral Hepatitis

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The global scale-up of hepatitis C virus (HCV) diagnosis requires simplified and affordable HCV diagnostic pathways. This study evaluated the sensitivity and specificity of the HCV Architect core antigen (HCVcAg) assay for detection of active HCV infection in plasma and capillary whole blood dried blood spots (DBS) compared with HCV RNA testing in plasma (Abbott RealTime HCV Viral Load). Samples were collected from participants in an observational cohort enrolled at three sites in Australia (two-drug treatment and alcohol clinics and one homelessness service). Of 205 participants, 200 had results across all samples and assay types and 186 were included in this analysis (14 participants receiving HCV therapy were excluded). HCV RNA was detected in 29% of participants ([95% CI: 22.6-36.1], 54 of 186). The sensitivity of HCVcAg for detection of active HCV infection in plasma was 98.1% (95% CI: 90-100) and 100% (95% CI: 93-100) when compared to HCV RNA thresholds of ≥12 and ≥1000 IU/mL, respectively. The sensitivity of the HCVcAg assay for detection of active HCV infection in DBS was 90.7% (95% CI: 80-97) and 92.5% (95% CI: 82-98) when compared to HCV RNA thresholds of ≥12 and ≥1000 IU/mL, respectively. The specificity of HCV core antigen for detection of active infection was 100% (95% CI: 97-100) for all samples and RNA thresholds. These data indicate that the detection of HCVcAg is a useful tool for determining active HCV infection; to facilitate enhanced testing, linkage to care and treatment particularly when testing plasma samples are collected by venepuncture. K E Y W O R D S diagnosis, diagnostic, dried blood spot, HCV core antigen, hepatitis C virus HCV core antigen DBS (≥3 fmol/L) Detected Undetected Total HCV RNA Plasma (≥12 IU/mL) Detected 49

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Section: Discussionsupporting

confidence: 91%

Section: Introductionmentioning

confidence: 99%

Evaluation of a hepatitis C virus core antigen assay from venepuncture and dried blood spot collected samples: A cohort study

Catlett

Lamoury

Bajis

et al. 2019

Journal of Viral Hepatitis

View full text Add to dashboard Cite

show abstract

“…However, first generation antigen tests had soon become unpopular due to their lack of sensitivity [ 7 ]. The chemiluminescent immunoassay based new generation HCV Ag test used in this study has a sensitivity of ≤ 3 fmol/L, offering 16- to 25-fold sensitivity compared to preceding tests [ 11 ].…”

Section: Discussionmentioning

confidence: 99%

Role of hepatitis C virus core antigen assay in hepatitis C care in developing country

Kallala

Kacem

Fodha

et al. 2021

Egypt Liver Journal

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Background The World Health Organization (WHO) aims to achieve global hepatitis C elimination by 2030, defined as diagnosis of 90% of infected individuals and treating 80% of them. Current guidelines for the screening and diagnosis of hepatitis C infection denote using a relatively cheap screen with anti-hepatitis C virus (HCV) antibody immunoassay, followed by the much costlier molecular test for HCV RNA levels using polymerase chain reaction (PCR) assay to confirm active HCV infection. Simplification of the HCV evaluation algorithm to reduce the number of required tests could considerably expand the provision of HCV treatment especially in a developing country. This study investigates the performance of hepatitis C Core Antigen (HCV Ag) test by comparing HCV Ag results versus the results obtained with HCV ribonucleic acid (RNA) PCR which is considered the gold standard for the diagnosis of HCV infection. Results Among the 109 anti-HCV positive sera, 96 were positive for both HCV Ag (> 3 fmol/L) and HCV RNA (> 15 IU/mL); 8 were negative for both tests, while the remaining 5 were positive for HCV RNA only. Considering the HCV RNA as gold standard; the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of HCV Ag test were found to be 95.05%, 100%, 100%, and 61.54%, respectively. HCV genotype was performed for 59 patients. The most common HCV genotype was genotype 1 (72.9%). Genotype 2 (15.3%) and genotype 3 (11.9%) were detected in the others samples. A high level of correlation was seen between HCV RNA and HCV Ag (r = 0.958, p < 0.001). The correlation for the samples that were genotyped 1 was significant (r = 0.966, p < 0.001). Conclusion In our study, it was found that there was strong correlation between HCV RNA levels and HCV Ag levels. So, it can be used for a one-step HCV antigen test to diagnose active HCV infection.

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“…The amount of HCV cAg in serum reflects the level of viremia to some extent. It has been reported abroad that without consideration of HCV genotypes, HCV RNA was correlated with HCV Ag . Kesli et al revealed that when compared to HCV RNA detection, HCV cAg's sensitivity, specialty, positive predictive value, and negative predictive value were 96.3%, 100%, 100%, and 89.7%, respectively.…”

Section: Discussionmentioning

confidence: 99%

The correlation of HCV RNA and HCV core antigen in different genotypes of HCV

Lai

Chen

et al. 2018

Clinical Laboratory Analysis

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Background To analyze the correlation of HCV RNA and HCV core antigen ( HCV cA g) in different genotypes of HCV . Methods One hundred and six patients who were diagnosed with HCV infection by HCV RNA test were included in the study. HCV genotypes were detected by PCR fluorescent probe. Detected HCV cA g's expression in serum quantitatively and qualitatively with chemiluminescent micro‐particle immuno assay ( CMIA ) and enzyme‐linked immunosorbent assay ( ELISA ), respectively, and compared positive rates. Analyzed the correlation of HCV RNA and HCV cA g in different genotypes. Results Distribution of HCV genotypes in 106 HCV infected patients were as follows: 1b genotype 46 (43.4%); 2a genotype 7 (6.6%); 3a genotype 18 (17.0%); 3b genotype 3 (2.8%); 6a genotype 9 (8.5%); 1b/3b mixed type 13 (12.3%); and unidentified type 10 (9.4%). Positive rates of HCV cA g detected by CMIA and ELISA were 100% and 56%, respectively, with statistical significance ( χ 2 = 60.38, P = 0.000). HCV cA g in 1b genotype group was higher than that in 3b and 1b/3b genotype groups, with statistical significance ( U = 3.0, P = 0.006, U = 165, P = 0.014). HCV RNA and HCV cA g in genotype 1b demonstrated a positive correlation ( r = 0.894, P = 0.04). Conclusion Major genetic subtype of HCV genotype was 1b. Compared with ELISA , detection of HCV cA g by CMIA increased the positive rate and facilitated early diagnosis and treatment of HCV ‐infected patients. With the increase in HCV RNA load and the expression of HCV cA g, HCV cA g could be an early indicator for the diagnosis of HCV infection in 1b genotype.

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Performance comparison of new generation HCV core antigen test versus HCV RNA test in management of hepatitis C virus infection

Cited by 12 publications

References 27 publications

Evaluation of a hepatitis C virus core antigen assay from venepuncture and dried blood spot collected samples: A cohort study

Evaluation of a hepatitis C virus core antigen assay from venepuncture and dried blood spot collected samples: A cohort study

Role of hepatitis C virus core antigen assay in hepatitis C care in developing country

The correlation of HCV RNA and HCV core antigen in different genotypes of HCV

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