New Test Diagnoses Hepatitis C in One Step

JUNE 07, 2016
Caitlyn Fitzpatrick
gastroenterology, hospital medicine, infectious disease, hepatology, hepatitis C, HCV, hep C, diagnosticsA 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. “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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