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Comparison of two diagnostic algorithms for the identification of patients with HCV viremia using a new HCV antigen
Miguel Ángel Reyes-Méndez1, Luis Juárez-Figueroa2, Patricia Iracheta-Hernández2
1Scientific Affairs Abbott Diagnostics.
Insights
Diagnosing hepatitis C virus (HCV) viremia can be done using two algorithms. The HCV core antigen test offers a feasible alternative to molecular methods for HCV diagnosis, especially when resources are limited.
Area of Science:
- Virology
- Clinical Diagnostics
- Infectious Diseases
Background:
- Hepatitis C virus (HCV) infection can lead to chronic viremia.
- Accurate diagnosis of HCV viremia relies on specific laboratory testing algorithms.
- Algorithm selection depends on available resources and population characteristics.
Purpose of the Study:
- To compare the diagnostic efficacy of two algorithms for identifying viremic HCV patients.
- To evaluate an algorithm using HCV core antigen (HCV Ag) testing against a molecular method (RT-PCR).
- To assess the performance of HCV Ag as a confirmatory test for anti-HCV results.
Main Methods:
- Compared diagnostic algorithms using anti-HCV, HCV Ag, and viral load (RT-PCR) measurements.
- Analyzed 211 patient samples (53 antibody positive, 158 antibody negative).
- Simulated diagnostic performance of two algorithms against RT-PCR as the gold standard.
Main Results:
- Both algorithms demonstrated high concordance in identifying viremic patients.
- RT-PCR based algorithm achieved 99.05% correct classification; HCV Ag algorithm achieved 98.10%.
- HCV core Ag test showed 0.917 clinical sensitivity and strong correlation (ρ=0.97) with molecular methods.
Conclusions:
- An algorithm using HCV Ag as a confirmatory test for anti-HCV is a viable alternative.
- This approach is suitable for laboratories lacking molecular techniques or needing faster results.
- HCV Ag testing provides a practical option for HCV diagnosis and viremia confirmation.
Background:
Patients exposed to hepatitis C virus (HCV) may develop chronic infection with viremia. The diagnosis of this condition requires the use of several laboratory tests in algorithms tailored to the population and resources available for each laboratory.
Aim:
We compared the diagnostic efficacy of two diagnostic algorithms for the identification of viremic patients with HCV. One based on confirmation of reactive antibody results with molecular techniques (reverse transcription polymerase chain reaction, RTPCR) and the other based on the use of a new HCV core antigen test (HCV Ag). Material and methods. We measured levels of anti-HCV, HCV Ag and viral load (trough RT-PCR) in parallel, in 211 samples (53 antibody positive, 158 antibody negative). Using the three results available for each sample we simulated the diagnostic performance of the two algorithms and compared them to the results of RT-PCR as gold standard.
Results:
Both algorithms showed a high degree of concordance for viremic patients. The percentage of correctly classified patients was 99.05% for the algorithm based on RT-PCR and 98.10% for the HCV Ag algorithm. The HCV core Ag test showed a clinical sensitivity of 0.917 and showed a good correlation to the results of molecular biology. Spearman rank correlation coefficient (ρ) of 0.97 (95% CI 0.95 to 0.99, p < 0.0001).
Conclusion:
An algorithm incorporating HCV Ag as confirmatory test for anti-HCV results is a feasible alternative to the use of molecular techniques in laboratories that do not have access to them or require faster turn around times.
