New Test Diagnoses Hepatitis C in One Step

A new test created by researchers at the University of California has cut the number of hepatitis C (HCV) diagnosis testing steps in half — meaning going from two steps to one.

Currently, patients are diagnosed with hepatitis C after undergoing a blood test, the Hepatitis C Antibody Test. If the antibodies prove to be reactive, then patients will have to have a follow-up test to confirm the diagnosis. There are one-step methods, HCV core antigen (HCVcAg) tests; however, they’ve been described as having low sensitivity and specificity. Researchers believe that this new one-step strategy has more valuable clinical potential.

The novel HCV antigens enzyme immunoassay (HCV-Ags EIA) was developed from analyzing 365 serum specimens — 189 with HCV and 176 without HCV.

• Related: Patients with Hepatitis C Have Higher Hospitalization Rates

“First, we confirmed presence of HCV non-structural protein 3 (NS3), NS4b, and NS5a proteins besides HCVcAg during HCV infection, and developed a novel HCV-Ags EIA via simultaneous detection of all these four HCV proteins,” the authors wrote in Hepatology.

The team made the new discovery that serum sample denaturation — the process where protein or nucleic acids lose their structure – decreases test specificity. Therefore, it shouldn’t be used in hepatitis C tests. So instead, the researchers used serum sample non-denaturation in the HCV-Ags EIA test and it showed 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 authors specified.

This test proved to screen and diagnosis hepatitis C infection in one step.

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