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.