HC010_Export_2024-06-10 Abbott Paper.xlsx

Dried blood spot samples (DBS) can help improve access to hepatitis C virus (HCV) testing for hard-to-reach populations. We conducted a multicentre diagnostic accuracy study to evaluate the performance of the Abbott m2000 platform for the detection of HCV RNA using DBS. The study was conducted at four sites in Cameroon, Rwanda, Georgia and Greece. The diagnostic accuracy of the Abbott RealTime HCV assay was assessed using DBS prepared from capillary and venous samples collected in three targeted populations: persons at risk of HCV, living with HCV, and treated for HCV. Abbott m2000 plasma samples were used as reference tests. In total, samples from 936 individuals (76.6% HCV antibody positive) were tested. Both capillary DBS and venous DBS showed a high sensitivity and specificity with 95.2% (95% CI: 92.9–96.8) and 95.6% (95%CI: 93.3–97.1), respectively, using capillary DBS and 95.4% (95% CI: 93.1–97.0) and 96.0% (95% CI: 93.8–97.4), respectively, using venous DBS. Overall, the Abbot RealTime HCV assay on the Abbott m2000 platform demonstrated strong performance in detecting HCV RNA using DBS. Our findings suggest that DBS can be used to screen for HCV infection in minoritized populations and in decentralized contexts. As a less costly and resource-dependent approach than plasma, DBS can improve HCV testing uptake, and accelerate access to HCV treatment.