Study: A New Test Simplifies Hepatitis C Diagnosis

A new test, developed by researchers at the University of California, can diagnose hepatitis C virus (HCV) infection in 1 step, according to a new study.

The current standard for diagnosing HCV requires an HCV antigen test to screen and then a test that confirms viremic HCV—a 2-step process that is costly, time consuming, and not globally available. Although there are currently 1-step HCV options (HCV core antigen tests), they have shown low sensitivity and specificity.
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The present study tested the sensitivity, specificity, and utility of a novel HCV antigens enzyme immunoassay (HCV-Ags EIA) in diagnosing HCV in 1 step.

To test the HCV-Ags EIA, the researchers analyzed 189 samples with HCV and 176 serum samples without HCV to confirm the 4 HCV proteins: nonstructural protein 3 (NS3), NS4b, NS5a, and HCV core antigen.

After assessing their results, the researchers found that serum sample denaturation decreases test specificity, so instead they used nondenumeration in their HCV-Ags EIA model.

The results showed that the HCV-Ags EIA had 99% specificity and 100% sensitivity.

“The highly specific and sensitive HCV-Ags EIA developed in the present study has the lowest limit of detection equivalent to serum HCV RNA levels of 150-250 IU/mL,” the researchers concluded.

“Using nondenaturation of serum samples, our HCV-Ags EIA reliably differentiated V-HCV infection from resolved HCV infection, accomplishes screening and diagnosis of V-HCV infection in one step.”

—Amanda Balbi

Reference:

Hu K-Q, Cui W. A highly specific and sensitive hepatitis C virus antigens enzyme immunoassay for one-step diagnosis of viremic HCV infection [published online June 6, 2016]. Hepatology. doi:10.1002/hep.28663.