Zeitschrift für molekulare Biomarker und Diagnose

The Utility of Automated HCV Core Antigen Assay as an Alternative to PCR in Chronic HCV Egyptian Patients

Abstract

Ehab M Abd El-reheem, Magdy Fouad, Hanaa Kh Fath El-bab and Waleed M Abd El-Hmeed

Hepatitis C is a disease with a significant global impact. Although the detection and quantitation of HCV RNA have been the standard method for the diagnosis and assessing individual patient response to the antiviral drug regimen, it is very sensitive testing, expensive, labor intensive, and requires technical skill.

Since the HCV core Ag assay is easy to perform in an immunoassay format, cheap, and less prone to sample carryover contamination compared to nucleic acid tests, There is an increasing interest to use HCV core antigen as a reflex test for seropositive individual to identify the active HCV infection also can be used to detect the early HCV infection.

Aim of the work: To compare the diagnostic accuracy of HCV core antigen with HCV-PCR in chronic HCV Egyptian patients.

Patients and methods: HCV core Ag was measured by a fully automated chemiluminescent immunoassay (CLIA) ABBOTT diagnostics in 57 patients proven to be chronic hepatitis C from those 32 were treated with pegylated interferon and ribavirin therpay and achieved HCV RNA negative six monthes after stoppage of treatment ( successful SVR) and 25 chronic HCV patients not considered for treatment . Viral load was quantified with branched DNA (bDNA, Versant, Siemens) also sera were tested with the Architect HCV Ag test (Abbott Laboratories). Statistical analysis was performed on logarithmically transformed values.

Results: HCV core antigen was detectable in 19/25 and grey zone in 4/25 HCV RNA positive sera while 2 sera were negative for HCV Ag. HCV-Ag was undetectable in all 32 HCV RNA negative samples. The sample with the lowest viral load that tested positive for HCV-Ag contained 1200 IU/mL HCV RNA. The levels of HCV core antigen showed a good correlation with those from the HCV RNA quantification (r = 0.907) HCV core Ag levels were correlated significantly with ALT levels (r = 0.516; P < 0.0001)

Conclusion: In conclusion, the Architect HCV antigen assay is highly sensitive, (>90%) reliable, easy to perform, cost-effective, and applicable as a screening, supplemental, and preconfirmatory test for anti-HCV assays used in laboratory procedures for the diagnosis of hepatitis C virus infection.