Rapid diagnostic tests for detection of antibodies to hepatitis C virus

Most patients with chronic hepatitis C often remain asymptomatic or experience nonspecific symptoms for decades, and by the time symptoms manifest, the disease has deteriorated to life-threatening stages such as cirrhosis or liver cancer. Early detection of hepatitis C virus (HCV) infection is crucial for preventing and managing subsequent complications. The conventional two-step diagnostic process, involving initial enzyme immunoassay testing for HCV antibodies (anti-HCV) followed by nucleic acid testing in the laboratory to confirm the presence of HCV, presents a significant challenge in the discovery and diagnosis of HCV virus infection. In addition to traditional laboratory-based serum antibody testing, the World Health Organization recommends the use of rapid diagnostic tests (RDTs) as one of the methods for analyzing anti-HCV antibodies, with the potential to improve access and linkage to care and treatment. Since 2020, the studies have shown that both the specificity and sensitivity of the anti-HCV RDTs have been improved. Three anti-HCV RDTs in Taiwan have received market approval, each demonstrating a sensitivity and specificity of at least 92.8% and 92.6%, respectively, as indicated by literature reviews. This article collects and summarizes existing literature on the diagnostic performance of anti-HCV RDTs and their implementation scenarios. It aims to enhance awareness across various sectors regarding the utility of anti-HCV RDTs and to discuss their potential applications in accelerating hepatitis C elimination efforts in Taiwan.