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A Protocol for Analyzing Hepatitis C Virus Replication
Published on: June 26, 2014
HCV Ag quantification as a one-step procedure in diagnosing chronic hepatitis C infection in Cameroon: the ANRS 12336
Léa Duchesne1, Richard Njouom2, Frédéric Lissock2
1Institut Pierre Louis d'épidémiologie et de Santé Publique (IPLESP UMRS 1136), Sorbonne Universités, UPMC Univ Paris 06, Inserm, Paris, France.
Insights
Hepatitis C core antigen (cAg) quantification is a sensitive and specific diagnostic tool for chronic hepatitis C infection (CHC). This method remains accurate even with co-infections like HIV or HBV, supporting "test and treat" strategies.
Area of Science:
- Hepatology
- Infectious Diseases
- Clinical Diagnostics
Background:
- Chronic hepatitis C infection (CHC) diagnosis typically involves anti-HCV antibody and HCV-RNA tests.
- HCV core antigen (cAg) quantification offers a potential one-step diagnostic approach to streamline CHC detection.
Purpose of the Study:
- To evaluate the diagnostic performance of HCV core antigen (cAg) quantification for CHC.
- To assess the impact of concomitant HIV or HBV infections on cAg assay performance.
Main Methods:
- A total of 1009 serum samples (465 HCV-Ab negative, 544 HCV-RNA positive) from Cameroon were analyzed.
- HCV cAg was quantified using an automated assay and compared against gold-standard methods (ELISA/PCR).
- Diagnostic sensitivity, specificity, and AUROC curves were calculated for different patient groups (HCV mono-infected, HCV-HBV, HIV-HCV co-infected).
Main Results:
- The cAg assay demonstrated high diagnostic performance for CHC with 95.7% sensitivity and 99.7% specificity (AUROC=0.99).
- Correlation between cAg and HCV-RNA levels was strong (Spearman ρ = 0.75, p < 0.00001).
- Concomitant HIV or HBV infections did not significantly alter cAg assay performance.
Conclusions:
- HCV cAg quantification is a highly sensitive and specific method for diagnosing CHC in Cameroon.
- The assay's accuracy is unaffected by co-infections with HIV or HBV.
- cAg quantification is a reliable tool for a "test and treat" strategy in global CHC elimination efforts.
Introduction:
The diagnostic procedure for chronic hepatitis C infection (CHC) usually combines anti-HCV antibody (HCV-Ab) and HCV-RNA measurement. Quantifying HCV core antigen (cAg) as a one-step procedure could shorten the diagnostic process. We aimed to assess the performance of cAg quantification in diagnosing CHC and how it is influenced by concomitant HIV or HBV infections.
Methods:
The cAg was quantified by an automated assay (Abbott Diagnostics) in 465 HCV-Ab negative serum samples and 544 HCV-RNA positive serum samples (n = 1009) collected in patients from the Pasteur Center in Cameroon, some of whom were infected by HBV or HIV. Its performance was evaluated in comparison to the gold standard (ELISA or PCR) by estimating its sensitivity (Se) and specificity (Sp), and by comparing the area under ROC (AUROC) curves in each patient population: HCV mono-infected, HCV-HBV and HIV-HCV co-infected.
Results:
Among the 465 HCV-Ab negative patients, 51 and 79 were HIV- and HBV-infected, respectively, whereas among the 544 patients with CHC, 27 and 28 were HIV- and HBV-infected, respectively. The Spearman ρ correlation coefficient between cAg and HCV-RNA was 0.75 (p < 0.00001). The assay had a sensitivity of 95.7% (95% CI: 93.2-97.5) and a specificity of 99.7% (95% CI: 98.1-10) in diagnosing CHC, corresponding to an AUROC of 0.99 (95% CI: 0.98-1.0). Being HIV- or HBV-infected did not impact the performance of cAg (Se = 96.4%, Sp = 96.2% and AUROC = 0.98 (95% CI: 0.95-1.0) in the HBV group, Se = 100%, Sp = 88.2% and AUROC = 0.99 (95% CI: 0.97-1.0) in the HIV group, p between AUROC = 0.69).
Conclusions:
The cAg quantification displayed a high specificity and sensitivity for the diagnosis of CHC in Cameroon, and its performance was not significantly modified by a concomitant HIV or HBV infection. In the context of CHC elimination on a global scale, using cAg quantification as a screening tool to directly identify CHC could be a reliable tool in a "test and treat" strategy.
