William F. Balistreri, MD


March 17, 2016

In This Article


HCV infections are significantly underdiagnosed, in part owing to the lack of a convenient, easy-to-use, cost-effective screening alternative. Current screening tests are specific and sensitive. However, to differentiate active from prior infection, the current sequential approach involves testing for anti-HCV and then, if positive, testing for HCV RNA via polymerase chain reaction to confirm viremia.

One-Step Diagnosis of Active Hepatitis C

Hu and Cui[10] developed a novel HCV antigens (HCV-Ags) enzyme immunoassay (EIA) that is specific and sensitive for one-step diagnosis of active HCV infection. All patients with acute or chronic HCV infection (all genotypes) and detectable serum HCV RNA levels tested positive for serum HCV-Ags, indicating 100% sensitivity and 100% specificity of the immunoassay. In acute HCV infection, HCV-Ags were detectable 59-65 days before the anti-HCV test became positive. The lower limits of detection of the HCV-Ags EIA were equivalent to serum HCV RNA levels of 150-250 IU/mL.

Hu and Cui[11] further assessed the feasibility, specificity, and sensitivity of their HCV-Ags EIA in one-step diagnosis of HCV infection by testing urine specimens. In persons without HCV infection, 100% of urine specimens tested negative for HCV-Ags. Similarly, in those with past or resolved HCV infection, all urine specimens tested negative for HCV-Ags, confirming 100% specificity of the assay.

In infected persons, all urine specimens tested positive for HCV-Ags, indicating a sensitivity of 100%. The lowest detection limit of the HCV-Ags EIA for urine specimens was equivalent to a serum HCV RNA level of 26 IU/mL.

This novel urine HCV-Ags EIA may eliminate the need for a blood specimen and establish a diagnosis of active HCV infection in a single noninvasive step, which could increase the capacity of global screening for pan-genotypic infections in a cost-effective manner.


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