HCV core-antigen assay as an alternative to HCV RNA quantification: A correlation study for the assessment of HCV

Roberto Alonso1, Felipe Pérez-García2, Paula López-Roa2

  • 1Servicio de Microbiología Clínica y Enfermedades Infecciosas, Hospital General Universitario Gregorio Marañón, Madrid, Spain; Facultad de Medicina, Universidad Complutense de Madrid, Spain.

Insights

The hepatitis C virus core antigen assay (HCV-Ag) shows excellent correlation with HCV RNA quantification, making it a valuable tool for diagnosing HCV infection, especially in emergencies.

Area of Science:

  • Hepatology
  • Virology
  • Clinical Diagnostics

Background:

  • Hepatitis C virus (HCV) RNA and HCV core antigen (HCV-Ag) assays are key for diagnosing active and chronic HCV infections.
  • Evaluating HCV-Ag as a viable alternative to HCV RNA quantification is crucial for improving diagnostic strategies.

Purpose of the Study:

  • To assess the sensitivity and specificity of the HCV-Ag assay compared to HCV RNA quantification.
  • To determine the correlation between HCV-Ag levels and HCV RNA viral load.
  • To establish a formula for estimating HCV RNA viral load from HCV-Ag values.

Main Methods:

  • A comparative study involving 204 serum samples.
  • Evaluation of the sensitivity and specificity of the HCV-Ag assay against a PCR-based HCV RNA assay.
  • Determination of the correlation between the two diagnostic techniques.

Main Results:

  • HCV-Ag assay demonstrated 76.6% sensitivity and 100% specificity.
  • An excellent correlation was observed between HCV-Ag and HCV RNA quantification (Pearson coefficient=0.951).
  • A formula was derived to estimate viral load: LogCV=1.15*LogAg+2.26; however, HCV-Ag could not detect viral loads below 5000 IU/mL.

Conclusions:

  • Despite lower sensitivity than PCR, the HCV-Ag assay exhibits strong correlation with HCV RNA levels.
  • HCV-Ag serves as a practical first-line diagnostic tool for acute or chronic HCV infection.
  • The assay is particularly useful in emergency settings for rapid HCV diagnosis.
Abstract