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DOI: 10.1055/s-2004-813429
© Karl Demeter Verlag im Georg Thieme Verlag KG Stuttgart · New York
Diagnostic Algorithm for Chronic Hepatitis C Virus Infection: Role of the New HCV-Core Antigen Assay
Diagnostischer Algorithmus für die chronische Hepatitis-C-Virusinfektion: Rolle des neuen HCV-Core-Antigen-TestsPublikationsverlauf
manuscript received: 16.3.2004
manuscript accepted: 22.6.2004
Publikationsdatum:
13. Januar 2005 (online)
![](https://www.thieme-connect.de/media/zfg/200501/lookinside/thumbnails/10.1055-s-2004-813429-1.jpg)
Zusammenfassung
Hintergrund: Die Diagnose einer chronischen Hepatitis C basiert derzeit auf dem Nachweis von HCV-RNA im Serum. Wir untersuchten die Rolle eines neuen serologischen Tests zur Detektion und Quantifizierung von HCV-Core-Antigen für die Diagnose einer chronischen Hepatitis-C-Virusinfektion. Patienten und Methoden: Zuvor mit vier verschiedenen HCV-RNA-Quantifizierungstests (Superquant, NGI; HCV-Monitor v 1.0 und v 2.0; Quantiplex 2.0) untersuchte Serumproben von 192 unbehandelten Patienten wurden mit dem trak-C-Test (Ortho Clinical Diagnostics, Raritan, NJ, USA) untersucht. Zusätzlich wurden bei 52 Patienten parallel Plasma und Serum untersucht. Bei 59 Patienten wurde eine Serumprobe mehrmals untersucht. Ergebnisse: 172/192 (89,6 %) der Proben unbehandelter Patienten zeigten ein positives Resultat mit dem trak-C-Test. Alle bis auf 2 der trak-C-positiven Proben waren auch PCR-positiv für HCV-RNA. Nur 4 der 20 trak-C-negativen Proben waren in 2 RNA-Tests positiv mit niedriger Viruslast (< 30 000 copies/ml). Das quantitative Ergebnis des trak-C zeigte eine sehr gute Korrelation zu den HCV-RNA-Spiegeln der verschiedenen HCV-RNA-Tests (r > 0,72; p > 0,001), gute Reproduzierbarkeit bei Re-Testung und gepaarten Serum/Plasma-Proben, unabhängig vom Genotyp. Schlussfolgerung: Basierend auf der guten Reproduzierbarkeit, der Einfachheit und dem vermutlich niedrigeren Preis von trak-C im Vergleich zu molekularen Nachweismethoden der HCV-Virämie, würden wir einen alternativen diagnostischen Algorithmus für die Hepatitis-C-Virusinfektion vorschlagen. trak-C könnte „Nucleotid Assay Tests” als initiale Bestätigung bei anti-HCV-positiven Patienten ersetzen. NAT würde nur bei trak-C-negativen Proben benötigt werden.
Abstract
Background: The diagnosis of chronic hepatitis C virus infection is based on nucleic acid testing (NAT) for HCV-RNA. We evaluated whether total HCV core antigen testing could be a substitute for NAT testing. Patients and Methods: Samples from 192 untreated chronic HCV positive patients previously tested for HCV-RNA by four different commercially available assays (SuperQuant, Amplicor HCV Monitor v 1.0 and v 2.0, Quantiplex) were tested for total HCV core antigen using the Ortho trak-C assay (Ortho Clinical Diagnostics, Raritan, NJ, USA). Furthermore, 52 HCV-RNA positive paired serum and plasma samples were analysed. Finally, inter-assay coefficients of variation for core antigen were determined by repeated testing of 59 samples. Results: 172/192 (89.6 %) samples from untreated HCV patients showed positive results with the trak-C assay. Importantly, all but two trak-C positive samples were NAT positive. Only four of the twenty trak-C negative samples tested positive by two NAT assays with viral loads below 30,000 copies/mL. Moreover, HCV core antigen levels correlated significantly with HCV-RNA levels (r > 0.72; p > 0.001), gave consistent results in paired serum and plasma samples (r = 0.991), and showed a very low inter-assay variability (r = 0.943) independent of genotype. Conclusion: Based on the performance characteristics, easiness of use, and potential lower cost of the core Ag assay, we propose an alternative testing algorithm for establishing the diagnosis of chronic HCV infection in which the trak-C assay could substitute for NAT as the first choice for detection of HCV viraemia in anti-HCV positive individuals. NAT would only be necessary in rare cases with low viral load.
Schlüsselwörter
HCV - Core-Antigen - Diagnostik
Key words
HCV - total core antigen - diagnostics
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Prof. Dr. med. Hans L. Tillmann
Medizinische Klinik & Poliklinik II, Universitätsklinikum Leipzig A.ö. R.
Philipp-Rosenthal-Str. 27
04103 Leipzig
Germany
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eMail: Hans.Tillmann@medizin.uni-leipzig.de