Inexpensive one-step test for hepatitis C developed

Current blood-based testing requires two steps and is expensive, inconvenient and not widely available globally

Scientists have developed a novel, cost-effective one-step test that screens, detects and confirms hepatitis C virus infections from urine samples.

Current blood-based hepatitis C virus (HCV) testing requires two steps and can be expensive, inconvenient and is not widely available or affordable globally.

"Our novel HCV antigen test system has significantly improved sensitivity and specificity over current tests," said Dr Ke-Qin Hu, professor of gastroenterology and hepatology at University of California - Irvine School of Medicine.

"Importantly, for the first time, we can use urine specimens for one-step screening and diagnosing of HCV infection," said Hu.

"Finding a more convenient, easy-to-use and cost-effective screening alternative is imperative, because HCV is significantly under-screened and under-diagnosed," Hu said.

Although the current HCV screening test is specific and sensitive, it cannot distinguish active infection from a previous infection. A blood sample is required, and two steps are required.

First, virus-specific antibodies must be detected in the blood. Then, the sensitive HCV RNA polymerase chain reaction (PCR) test must be administered to confirm whether or not the infection is active.

Hu said many developing countries are not equipped to administer the two-step test, especially the HCV RNA PCR test. In the US, its cost is above $200.

The novel HCV antigen test system developed by Hu's UC Irvine lab could significantly reduce the cost, human resources and time required for the test results.

"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," Hu said.

According to the Centres for Disease Control and Prevention, approximately 150 million people worldwide and 3.2 million people in the US are infected with HCV. Effective screening and fast diagnosis are critical for treatment and controlling transmission.

"Those who are HCV infected can now be cured, before a further liver injury and complications develop, but only if they are diagnosed," Hu said.

People with an HCV infection do not usually experience symptoms until more serious liver injury develops, such as fibrosis, cirrhosis, or liver cancer.