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

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Title: 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
Authors: Mohamed, Z
Mbwambo, J
Shimakawa, Y
Poiteau, L
Chevaliez, S
Pawlotsky, J-M
Rwegasha, J
Bhagani, S
Taylor-Robinson, SD
Makani, J
Thursz, MR
Lemoine, M
Item Type: Journal Article
Abstract: Introduc tion : 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, particu- larly 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.
Issue Date: 19-Sep-2017
Date of Acceptance: 22-Aug-2017
ISSN: 1758-2652
Publisher: International AIDS Society
Journal / Book Title: Journal of the International AIDS Society
Volume: 20
Copyright Statement: © 2017 Mohamed Z et al. licensee International AIDS Society. This is an Open Access article distributed under the terms of the Creative Commons Attribution 3.0 Unported (CC BY 3.0) License ( ), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Sponsor/Funder: Wellcome Trust
Wellcome Trust
Funder's Grant Number: 097816/Z/11/ZR
Keywords: Science & Technology
Life Sciences & Biomedicine
Infectious Diseases
people who inject drugs
hepatitis C virus (HCV)
dried blood spot
HCV core antigen
1199 Other Medical And Health Sciences
Publication Status: Published
Article Number: ARTN 21856
Appears in Collections:Department of Surgery and Cancer