One-Step Test Developed for Hepatitis C Virus Infection

A cost-effective one-step test that screens, detects, and confirms Hepatitis C virus (HCV) infections has been developed as an alternative to current blood-based HCV testing that requires two steps and can be expensive, inconvenient, and not widely available or affordable globally.

Although the current HCV screening test is specific and sensitive, it cannot distinguish active infection from a previous infection, and virus-specific antibodies must be detected in the blood and then the sensitive HCV ribonucleic acid polymerase chain reaction (RNA PCR) test must be administered to confirm whether or not the infection is active.


Scientists at the University of California Irvine (CA, USA) developed the new test that samples urine instead of blood, and there is potential to significantly reduce the human resources, time, and cost involved with testing. The HCV RNA PCR test in the USA costs more than USD 200. The new assay is a highly specific and sensitive HCV antigens enzyme immunoassay (HCV-AGS EIA) for one-step diagnosis of viremic HCV infection.

According to the Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA), approximately 150 million people worldwide and 3.2 million people in the USA are infected with HCV. Effective screening and fast diagnosis are critical for treatment and controlling transmission. People with an HCV infection do not usually experience symptoms until more serious liver injury develops, such as fibrosis, cirrhosis, or liver cancer. The CDC recommends screening tests for high-risk patients, including intravenous drug users, and individuals who had blood transfusions before 1992, as well as those born between 1945 and 1965.

Dr. Ke-Qin Hu, MD, director of hepatology services and lead author of the study, said, “Our novel HCV antigen test system has significantly improved sensitivity and specificity over current tests. Importantly, for the first time, we can use urine specimens for one-step screening and diagnosing of HCV infection. Finding a more convenient, easy-to-use and cost-effective screening alternative is imperative, because HCV is significantly under-screened and under-diagnosed. The ability to detect infection using urine rather than blood avoids needle stick and blood sample collection, greatly reduces the cost and necessary clinical infrastructure for screening and diagnosis, helping to promote widespread adoption of the test on a global scale.” The study was presented at the Annual Meeting of American Association for the Study of Liver Disease (AASLD) held November, 14–16, 2015, in San Francisco (CA, USA).

Related Links:
University of California Irvine 
US Centers for Disease Control and Prevention