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Evaluation of a hepatitis C virus core antigen assay from venepuncture and dried blood spot collected samples: A cohort study.
- Source :
-
Journal of viral hepatitis [J Viral Hepat] 2019 Dec; Vol. 26 (12), pp. 1423-1430. Date of Electronic Publication: 2019 Sep 18. - Publication Year :
- 2019
-
Abstract
- 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.<br /> (© 2019 John Wiley & Sons Ltd.)
- Subjects :
- Adult
Cohort Studies
Female
Hepatitis C immunology
Humans
Male
Middle Aged
Public Health Surveillance
Sensitivity and Specificity
Seroepidemiologic Studies
Serologic Tests
Hepacivirus immunology
Hepatitis C epidemiology
Hepatitis C virology
Hepatitis C Antigens blood
Hepatitis C Antigens immunology
Viral Core Proteins blood
Viral Core Proteins immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1365-2893
- Volume :
- 26
- Issue :
- 12
- Database :
- MEDLINE
- Journal :
- Journal of viral hepatitis
- Publication Type :
- Academic Journal
- Accession number :
- 31448470
- Full Text :
- https://doi.org/10.1111/jvh.13196