Retrospective Evaluation of Serological and Molecular Tests for Determination of Anti-HCV Screening Test Cut-Off

Abstract

Objective: We aimed to determine an appropriate anti-HCV test cut-off value for the HCV-RNA study and contribute to the development of correct algorithms by evaluating our hospital’s anti HCV and HCV-RNA test results between 2017-2019. Methods: Available HCV-RNA test results of patients who were found to have reactivity in anti-HCV were analyzed. Patients with anti-HCV reactivity were analyzed by dividing into age groups 0-20 years, 21-40 years, 41-60 years, and ≥61 years. HCV-RNA results were also evaluated within the same age groups. Patients with anti-HCV reactivity were divided into three groups according to their S/Co values as 1-5 mLU/mL, 5.1-10 mLU/mL, and ≥10.1 mLU/mL, and statistical analysis was performed. Results: Anti-HCV reactive results were divided into groups of 1.0-3.8 mLU/mL and ≥3.9 mLU/mL according to S/Co values, and HCV-RNA positivity was 2% and 44.4% respectively. When divided into three groups as 1-5 mLU/mL, 5.1-10 mLU/mL, and ≥10.1 mLU/mL according to S/Co values, the HCV RNA positivity rate was 1.8%, 25%, and 55.2%, respectively. The difference between the groups was statistically significant. Conclusion: Countries should carry out comprehensive studies to represent their populations to determine cut-off values for widely used kits and to make this applicable with algorithms.