Hepatitis C virus RNA tests: performance attributes and their impact on clinical utility

The diagnostic market is driven by the burden of disease in the population and the ease or difficulty of disease diagnosis. The efficacy of available therapeutics determines the need for monitoring. Hepatitis C virus currently affects approximately 3% of the world's population, although the overall response rate to the best available therapies is 56%. Research regarding hepatitis C virus remains elusive due to lack of an efficient cell culture system. Diagnosis and monitoring of active hepatitis C virus infection therefore rely on sophisticated molecular tests. This review will focus on current molecular tests for hepatitis C virus RNA and the performance attributes that these tests require for accurate diagnosis and monitoring of infection.