Abstract

BackgroundNucleic acid tests performed on blood samples collected on Dried Blood Spot (DBS) and detection of HCV core antigen (HCVcAg) are two approaches that may facilitate access to HCV diagnosis in low and middle incomes countries. In this study we evaluate HCV RNA and HCV antigen testing on DBS in HIV/HCV co-infected peoples who inject drugs in Vietnam.MethodOne hundred and four HIV/HCV seropositive patients managed in outpatient care at the Haiphong Viet Tiep hospital were included in this study from February to March, 2014 (ANRS 12262 study).ResultsEighty-six subjects were tested positive for HCV RNA in serum, median (IQR): 6.9 log10 IU/ml (5.6–7.4 log10 IU/ml). Genotypes consisted of 57 G1 (69%), 3 G3 (4%), and 22 G6 (27%). HCV RNA was detected on DBS specimens in 79 out 86 subjects with chronic hepatitis C (sensitivity 92.5%; 95% CI: 85.1–96.9%). HCV RNA level on DBS and serum was moderately correlated (r = 0.24; p = 0.05) suggesting a degradation of HCV RNA due to transportation and storage conditions. HCVcAg was detected in 75/86 dB specimens (sensitivity: 87.2%; 95% CI: 78.3–93.4%), with a strong positive relationship between DBS HCVcAg and serum HCV RNA levels (r = 0.80; P < 0.0001).ConclusionsQuantification of HCVcAg on DBS appears to benefit from substantial stability under prolonged storage conditions but with a lower analytical sensitivity compared to DBS HCV RNA testing. Detection of HCV RNA on DBS is an interesting approach for confirming viral replication in HCV seropositive persons but the impact of pre-analytical conditions on the integrity of HCV RNA needs to be controlled.

Highlights

  • Nucleic acid tests performed on blood samples collected on Dried Blood Spot (DBS) and detection of hepatitis C virus (HCV) core antigen (HCVcAg) are two approaches that may facilitate access to HCV diagnosis in low and middle incomes countries

  • In this study we evaluate the performance of HCV Ribonucleic acid (RNA) and HCV antigen detection on DBS collected in Haiphong Viet Tiep Hospital and compared to serum Polymerase chain reaction (PCR) using open polyvalent PCR platform

  • We observed a good correlation between DBS using the Biocentric assay and serum HCV RNA using the Roche assay (Fig. 1a) (r = 0.9488; P < 0.0001)

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Summary

Introduction

Nucleic acid tests performed on blood samples collected on Dried Blood Spot (DBS) and detection of HCV core antigen (HCVcAg) are two approaches that may facilitate access to HCV diagnosis in low and middle incomes countries. In this study we evaluate HCV RNA and HCV antigen testing on DBS in HIV/HCV co-infected peoples who inject drugs in Vietnam. Decisive breakthrough was recently achieved in hepatitis C virus (HCV) antiviral therapy but the limited access to reliable and low-cost HCV diagnosis tools is a key barrier in the global fight against HCV epidemic [1]. Poor laboratory capacities and logistical difficulties represent key barriers for the scaling testing and the treatment, in rural areas and difficult to reach populations

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