Evaluation of the Aptima HCV Quant Dx Assay for HCV RNA detection from finger-stick capillary dried blood spot and venepuncture-collected samples.

BACKGROUND Simplified diagnostic strategies to increase hepatitis C virus (HCV) testing to determine active infection and link people into treatment are needed. Collection methods such as dried blood spots (DBS) have advantages over standard phlebotomy especially within marginalized populations. METHODS We evaluated the diagnostic performance of the Aptima® HCV Quant assay for the quantification and detection of HCV RNA from paired DBS and venepuncture samples. Specimens were collected from participants enrolled in an Australian observational study. We compared HCV RNA detection from DBS against venepuncture samples (gold standard). RESULTS 164 participants had paired samples and HCV RNA was detected in 45 (27% [95% CI 21-35]) by the Aptima® assay in venepuncture samples. Sensitivity of the Aptima® assay for HCV RNA quantification from DBS (≥10 IU/mL in plasma) was 100% and specificity was 100%. Sensitivity for HCV RNA detection from DBS was 95.6% and specificity was 94.1%. A small bias in plasma over DBS was observed with good agreement (R2=0.96). CONCLUSIONS The Aptima® HCV Quant assay detects active infection from DBS with acceptable diagnostic performance and is clinically comparable to plasma. These data will strengthen the case for the registration of a DBS kit insert claim, enabling future clinical utility.