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Z Gastroenterol 2014; 52(10): 1164-1170
DOI: 10.1055/s-0034-1366618
Originalarbeit
© Georg Thieme Verlag KG Stuttgart · New York

Hepatitis-C-Diagnostik: Klinische Evaluierung der HCV-Core-Antigenbestimmung

Hepatitis C Diagnostics: Clinical Evaluation of the HCV-Core Antigen Determination
J. van Helden
1   MVZ Dr. Stein und Kollegen, Mönchengladbach
,
R. Weiskirchen
2   Institut für Molekulare Pathobiochemie, Experimentelle Gentherapie und Klinische Chemie, Universitätsklinikum Aachen
› Author Affiliations
Further Information

Publication History

07 November 2013

11 May 2014

Publication Date:
14 October 2014 (online)

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Zusammenfassung:

Hintergrund: Ziel der Arbeit ist es, die Bedeutung des seit Kurzem verfügbaren HCV-Core-Antigentests für die Diagnostik und Verlaufskontrolle der HCV-Infektion in der täglichen Praxis aufzuzeigen. Die serologische Diagnostik wurde bisher hauptsächlich mittels Antikörpernachweis durchgeführt. Die Bestimmung der Aktivität sowie das Therapiemonitoring erfolgte mittels Hepatits-C-RNA-PCR.

Methoden: Aus den Routineanforderungen eines medizinischen Großlabors wurden über 2 Jahre die Hepatitis-C-Anforderungen ausgewertet unter besonderer Berücksichtigung der HCV-Core-Antigentests.

Ergebnisse: Die Bestimmung des HCV-Antigens korreliert hervorragend mit dem quantitativen Nachweis der HCV-RNA (r = 0,73, p = 0,0003). Das diagnostische Fenster ist vergleichbar mit der PCR-Untersuchung (27,1 ± 12,8 d vs. 23,9 ± 9,2 d, p = 0,11). Die Sensitivität der HCV-Ag-Bestimmung lag bei 99 % bei einer Spezifität von 99,2 % für die Erkennung von aktiven HCV-Infektionen im Vergleich zur HCV-RNA-PCR. In 54,3 % der HCV-Antikörper positiven Proben war HCV-Core-Antigen nachweisbar. Lediglich in 3 von 560 HCV-RNA-positiven Proben war kein HCV-Antigen nachweisbar. Drei HCV-Antigenproben waren anti-HCV negativ.

Schlussfolgerungen: Der HCV-Core-Antigentest eignet sich neben der Erkennung von chronisch aktiven Infektionen, zur Frühdiagnose von akuten HCV-Infektionen und zur Diagnostik von Hepatitis C bei Immunsupprimierten mit fehlendem Antikörpernachweis. Der HCV-Core-Antigentest ist somit eine wertvolle Ergänzung der serologischen HCV-Diagnostik.

Abstract

Background: The aim of the evaluation was to investigate the relevance of the HCV-core antigen testing for the diagnosis and monitoring of HCV infections in the daily routine. Up to now, most of the serological diagnostics was performed as determination of antibodies while the determination of activity and the monitoring of antiviral therapy were checked by HCV RNA PCR.

Methods: The routine requests for HCV-core antigen of a private laboratory were analyzed for a period of two years.

Results: The determination of HCV antigen highly correlates with the quantitative measurement of HCV RNA (r = 0.73), p = 0.0003). The diagnostic window is comparable with that of the HCV PCR (27.1 ± 12.8 d vs. 23.9 ± 9.2 d, p = 0.11). The sensitivity of the HCV antigen assay was 99.0 % with a specificity of 99.2 %. 54.3 % of the confirmed antibody positive samples were also antigen positive. Only in 3 of 560 HCV-RNA positive samples HCV antigen was not detectable, but 3 samples without HCV antibodies were confirmed positive for HCV antigen.

Conclusions: The HCV antigen assay is a suitable tool for the detection of chronic active HCV infections, for the early diagnosis of acute infections and for testing of HCV in patient with immunodeficiency. The HCV antigen assay valuable completion of serological testing for HCV.

Schlüsselwörter

Hepatitis C - HCV-Core-Antigen - Sensitivität - Spezifität - diagnostisches Fenster

Key words

hepatitis C - HCV-core-antigen - sensitivity - specificity - diagnostic window
 

  • Literatur

  • 1 Poethko-Müller C, Zimmermann R, Homouda O et al. Epidemiology of hepatitis A, B and C among adults in Germany: results of the German Health Interview and Examination Survey for Adults (DEGS1). Bundesgesundheitsblatt 2013; 56: 707-715
    PubMedGoogle Scholar
  • 2 Robert Koch Institut: Epidemiologisches Bulletin 30/2013.
    PubMedGoogle Scholar
  • 3 Robert Koch Institut: Epidemiologisches Bulletin 46/2005.
    PubMedGoogle Scholar
  • 4 Armstrong GL, Wasley A, Simard EP et al. The prevalence of hepatitis C virus infection in the United States. Annals Int Med 2006; 144: 705-714
    CrossrefPubMedGoogle Scholar
  • 5 Mutimer D, Aghemo A, Diepolder H et al. EASL Clinical Practice Guidelines: Management of hepatitis C virus infection. J Hepatol 2014; 60: 392-420
    CrossrefPubMedGoogle Scholar
  • 6 Detering K, Grüner N, Buggisch P et al. Delayed versus immediate treatment for patients with acute hepatitis C: a randomized controlled non inferiority trial. Lancet Infect. Diseas 2013; 13: 497-506
    PubMedGoogle Scholar
  • 7 Laperche S, Elghouzzi MH, Morel P et al. Is an assay for simultaneous detection of hepatitis C virus core antigen and antibody a valuable alternative to nucleic acid testing?. Transfusion 2005; 45: 1965-1972
    CrossrefPubMedGoogle Scholar
  • 8 Hayashi K, Hasuike S, Kusumoto K et al. Usefulness of a new immuno-radiometric assay to detect hepatitis C core antigen in a community-based population. J Viral Hepatitis 2005; 12: 106-110
    CrossrefPubMedGoogle Scholar
  • 9 Maynard M, Pradat P, Berthillon P et al. Clinical relevance of total HCV Core antigen testing for hepatitis C monitoring and for predicting patients’ response to therapy. J Viral Hepatitis 2003; 10: 318-323
    CrossrefPubMedGoogle Scholar
  • 10 Gonzales V, Padilla E, Diago M et al. Clinical usefulness of total hepatitis C virus core antigen quantification to monitor the response to treatment with peginterferon alpha-2a plus ribavirin. J Viral Hepatitis 2005; 12: 481-487
    CrossrefPubMedGoogle Scholar
  • 11 NCCLS Document EP5A. Evaluation of precision performance of clinical chemistry devices. Approved guidline. 1999 2nd ed.
    PubMedGoogle Scholar
  • 12 Ross RS, Viazov S, Salloum S et al. Analytical performance characteristics and clinical utility of a novel assay for total hepatitis C virus core antigen quantification. JCM 2010; 48 (04) 1161-1168
    CrossrefPubMedGoogle Scholar
  • 13 Dati F, Denoyel G, van Helden J. European performance evaluations of the ADVIA Centaur® infectious disease assays: requirements for performance evaluation according to the European directive on in vitro diagnostics. J Clin Virol 2004; 30: 5-9
    CrossrefPubMedGoogle Scholar
  • 14 Mederacke I, Wedemeyer H, Ciesek S et al. Performance and clinical utility of a novel fully automated quantitative HCV-core antigen assay. J Clin Virol 2009; 46: 210-221
    CrossrefPubMedGoogle Scholar
  • 15 Morota K, Fujinami R, Kinikawa H et al. A new sensitive and automated chemiluninescent microparticle immunoassay for the quantitative determination of hepatitis C core antigen. J Virol Method 2009; 157: 8-14
    CrossrefPubMedGoogle Scholar
  • 16 Esteban JI, van Helden J, Alborino F et al. Multicenter Evaluation of the Elecsys® Anti-HCV II Assay for the Diagnosis of Hepatitis C Virus Infection: J. Med. Virol 2013; 85: 1362-1368
    CrossrefPubMedGoogle Scholar
  • 17 Midouge M, Saune K, Kamar N et al. Analytical evaluation of HCV core antigen and interest for HCV screening in haemodialysis patients. J Clin Virol 48 2010; 48: 18-21
    PubMedGoogle Scholar
  • 18 Seger G. Drogen und Hepatitis C: Neue Konzepte der Prävention gesucht. DÄ 2004; 101: 1929
    PubMedGoogle Scholar