Abstract
Early diagnosis of hepatitis C virus (HCV) infection is essential for prompt initiation of treatment and prevention of transmission, yet several logistical barriers continue to limit access to HCV testing. Dried blood spot (DBS) technology involves a simple fingerstick that eliminates the need for trained personnel, and DBS can be stored and transported at room temperature. We evaluated the use of DBS whole blood samples in the modified Abbott ARCHITECT anti-HCV assay, comparing assay performance against the standard assay run using DBS and venous plasma samples. 144 HCV positive and 104 HCV negative matched venous plasma and whole blood specimens were selected from a retrospective study with convenience sampling in Cameroon. Results obtained using a modified volume DBS assay were highly correlated to the results of the standard assay run with plasma on clinical samples and dilution series (R2 = 0.71 and 0.99 respectively). The ARCHITECT Anti-HCV assay with input volume modification more accurately detects HCV antibodies in DBS whole blood samples with 100% sensitivity and specificity, while the standard assay had 90.97% sensitivity. The use of DBS has the potential to expand access to HCV testing to underserved or marginalized populations with limited access to direct HCV care.
Highlights
When DBS were eluted in assay diluent (AD), we observed a roughly two-fold decrease in assay sensitivity compared to elution buffer (EB)
Dilutional sensitivity using the modified assay file with 12-mm DBS eluted in EB was equivalent to the standard on-market assay with plasma samples; both DBS and plasma were positive at a dilution of 1:500 with comparable S/CO values (Table 1)
DBS eluted in PBS/Triton buffer and tested using a modified assay file with the increased sample input volume
Summary
Dilutional sensitivity using the modified assay file with 12-mm DBS eluted in EB was equivalent to the standard on-market assay with plasma samples; both DBS and plasma were positive at a dilution of 1:500 with comparable S/CO values (Table 1). For N = 144 anti-HCV/ RNA positive matched samples, DBS samples were prepared and tested using the standard and modified antiHCV assay (Fig. 2), and the results were compared to those from plasma samples.
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