Format

Send to

Choose Destination
J Int AIDS Soc. 2017 Sep 19;20(1):21856. doi: 10.7448/IAS.20.1.21856.

Clinical utility of HCV core antigen detection and quantification using serum samples and dried blood spots in people who inject drugs in Dar-es-Salaam, Tanzania.

Author information

1
Department of Hepatology, Imperial College London, St Mary's Hospital, London, UK.
2
Department of Psychiatry, Muhimbili University of Health and Allied Sciences, Muhimbili National Hospital, Dar es Salaam, Tanzania.
3
Unité d'Épidémiologie des Maladies Émergentes, Institut Pasteur, Paris, France.
4
French National Reference Center for Viral Hepatitis B, C and delta; Department of Virology; Hopital Henri Mondor, Université Paris-Est, Créteil, France.
5
Department of Gastroenterology, Muhimbili National Hospital, Dar es Salaam, Tanzania.
6
Department of HIV Medicine and Infectious Diseases, The Royal Free Hospital, London, UK.
7
Department of Haematology, Muhimbili University of Health and Allied Sciences, Muhimbili National Hospital, Dar es Salaam, Tanzania.

Abstract

INTRODUCTION:

A lack of access to hepatitis C virus (HCV) diagnostics is a significant barrier to achieving the World Health Organization 2030 global elimination goal. HCV core antigen (HCVcAg) quantification and dried blood spot (DBS) are appealing alternatives to conventional HCV serology and nucleic acid testing (NAT) for resource-constraint settings, particularly in difficult-to-reach populations. We assessed the accuracy of serum and DBS HCVcAg testing in people who inject drugs in Tanzania using HCV NAT as a reference.

METHOD:

Between May and July 2015, consecutive HCV-seropositive patients enrolled in the local opioid substitution treatment centre were invited to participate in the study. All had HCV RNA detection (Roche Molecular Systems, Pleasanton, CA, USA), genotyping (NS5B gene phylogenetic analysis) and HCVcAg on blood samples and DBS (Architect assay; Abbott Diagnostics, Chicago, IL, USA).

RESULTS:

Out of 153 HCV-seropositive individuals, 65 (42.5%) and 15 (9.8%) were co-infected with HIV (41 (63%) were on anti-retroviral therapy (ARVs)) and hepatitis B respectively. In total, 116 were viraemic, median viral load of 5.7 (Interquartile range (IQR); 4.0-6.3) log iU/ml (75 (68.2%) were genotype 1a, 35 (31.8%) genotype 4a). The median alanine transaminase (ALT) (iU/l), aspartate transaminase (AST) (iU/l) and gamma-glutamyl transferase (GGT) (iU/l) were 35 (IQR; 23-51), 46 (32-57) and 69 (35-151) respectively. For the quantification of HCV RNA, serum HCVcAg had a sensitivity at 99.1% and a specificity at 94.1%, with an area under the receiver operating curve (AUROC) at 0.99 (95% CI 0.98-1.00). DBS HCVcAg had a sensitivity of 76.1% and a specificity of 97.3%, with an AUROC of 0.87 (95% CI 0.83-0.92). HCVcAg performance did not differ by HIV co-infection or HCV genotype. Conclusions Our study suggests that HCVcAg testing in serum is an excellent alternative to HCV polymerase chain reaction in Africa. Although HCVcAg detection and quantification in DBS has a reduced sensitivity, its specificity and accuracy are good and it could therefore be used for scaling up HCV testing and care in resource-limited African settings.

KEYWORDS:

Africa; HCV core antigen; dried blood spot; hepatitis C virus (HCV); people who inject drugs; screening

PMID:
28953324
PMCID:
PMC5964737
DOI:
10.7448/IAS.20.1.21856
[Indexed for MEDLINE]
Free PMC Article

Supplemental Content

Full text links

Icon for Wiley Icon for PubMed Central
Loading ...
Support Center