Prescreening with a Rapid Diagnostic Test Followed by a Confirmatory Qualitative Nucleic Acid Test Can Simplify Hepatitis C Diagnosis

Abstract

ABSTRACT. Asymptomatic hepatitis C virus (HCV) infection without treatment is associated with chronic liver diseases including hepatocellular carcinoma. A major obstacle to hepatitis C diagnosis leading to antiviral treatment in some developing countries is the complicated HCV testing required before treatment. To simplify an HCV test-to-treat strategy, which could lead to timely diagnosis and treatment at the point-of-care, we evaluated the performance of four anti-HCV rapid diagnostic tests (RDTs) (Abon, Blue Cross, Healgen, and SD Bioline). They yielded comparable sensitivity (80–83%), specificity (99–100%), and accuracy (90–91.5%). When we field-tested Abon in 4,769 residents of an HCV-endemic province in Thailand, 306 seropositive individuals (6.4%) were identified. In comparison, laboratory test using an automated commercial chemiluminescent microparticle immunoassay (ARCHITECT anti-HCV assay, Abbott Diagnostics, Chicago, IL) identified slightly more seropositives (327/4,769 or 6.9%). Field implementation suggests that Abon was sensitive (88.7%), specific (99.6%), and accurate (98.9%). Furthermore, 82% (250/306) of Abon-positive samples had detectable HCV RNA as determined by nucleic acid test (cobas® 4800 HCV assay; Roche Diagnostics GmbH, Mannheim, Germany). The same 250 samples out of 327 reactive in Abbott immunoassay also had detectable HCV RNA (mean RNA level: log 6.28 IU/mL, range: log 3.06– 7.78 IU/mL). The use of RDT followed by qualitative nucleic acid test can cost-effectively identify the majority of HCV seropositive individuals with active infection, which will obviate the need for expensive viral load quantification tests when simplifying HCV diagnosis for the test-to-treat program at the point-of-care.