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Updated: Oct 29, 2025
Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection
Published on: December 15, 2023
Performance of rapid diagnostic tests for HCV infection in serum or plasma
Stéphane Chevaliez1,2, Françoise Roudot-Thoraval2,3, Christophe Hézode2,3
1Department of Virology, National Reference Center for Viral Hepatitis B, C & Delta, Hôpital Henri Mondor, Université Paris-Est, Créteil, France.
Insights
Accurate and affordable rapid diagnostic tests (RDTs) are crucial for hepatitis C virus (HCV) diagnosis. Seven RDTs showed high sensitivity and specificity, with two assays performing exceptionally well for global HCV elimination efforts.
Area of Science:
- Hepatology
- Infectious Diseases
- Public Health
Background:
- Hepatitis C virus (HCV) diagnosis is a significant barrier to global elimination efforts.
- There is a critical need for simple, accurate, and cost-effective testing strategies to enhance HCV screening and diagnosis.
- Current diagnostic methods require improvement to meet the demands of large-scale public health initiatives.
Purpose of the Study:
- To evaluate the performance of seven rapid diagnostic tests (RDTs) for Hepatitis C virus (HCV) antibody detection.
- To assess the clinical sensitivity and specificity of these RDTs using a large sample size.
- To identify RDTs suitable for WHO prequalification and integration into low-cost treatment programs.
Main Methods:
- A comparative performance assessment of seven different HCV RDTs was conducted.
- Serum or plasma specimens from 498 individuals in France and Cameroon were analyzed.
- Immunoassays served as the reference standard for determining clinical sensitivity and specificity.
Main Results:
- All seven RDTs demonstrated high clinical sensitivity, ranging from 97.2% to 100%.
- Specificities were also high, varying between 96.1% and 100%.
- The Multisure HCV antibody assay and OraQuick HCV rapid antibody test achieved a sensitivity of 99% or greater.
Conclusions:
- Several RDTs exhibit performance characteristics suitable for World Health Organization (WHO) prequalification.
- These validated RDTs can be instrumental in implementing large-scale, cost-effective treatment programs.
- Successful implementation of these tests will contribute significantly to achieving the WHO's viral hepatitis elimination objectives by 2030.
Abstract:
Aim: HCV diagnosis will become the bottleneck in eliminating hepatitis C. Simple, accurate and cost-effective testing strategies are urgently needed to improve hepatitis C screening and diagnosis. Materials & methods: Performance of seven rapid diagnostic tests (RDT) have been assessed in a large series (n = 498) of serum or plasma specimens collected in France and in Cameroon. Results: Specificity varied from 96.1 to 100%. The clinical sensitivity, compared with immunoassays as the reference, was high for all seven RDT (97.2-100%). The Multisure HCV antibody assay and OraQuick HCV rapid antibody test reached sensitivity ≥99%. Conclusion: A number of RDT may be suitable for WHO prequalification and may be implemented in the framework of large-scale low-cost treatment programs to achieve the WHO viral hepatitis objectives by 2030.
