Assessing the Utility of Shortened Read Time of the Abbott Bioline HCV Test to Predict Viremia

The current two-step model for HCV diagnosis risks losing people from care; a one-step diagnostic approach could improve retention. We investigated whether shortening the read time of an HCV antibody test from 20-min to 1 or 5-min could accurately predict HCV RNA viremia in-lieu of a standard RNA test. 1110 people in Yangon had a HCV Ab using Bioline HCV RDT. Results were recorded at 1-min intervals until 20-min, with HCV RNA testing of reactive results at 20-min. 884 participants returned both antibody and RNA results; 838 were Ab reactive at 1-min, 875 were reactive at 5-min and 728 were RNA positive. Sensitivity was 98.6% and 100% for 1 and 5-min read-times, and specificity was 23.1% and 5.8% for 1 and 5-min respectively. Our results suggest that reading the Bioline at 5 min has potential to identify patients with HCV infection ahead of reflexive RNA testing. Trial Registration: ClinicalTrials.gov:NCT03939013.