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A Rapid Point-of-Care Test for the Serodiagnosis of Hepatitis Delta Virus Infection
Viruses. 2021 Nov 26;13(12):2371. doi: 10.3390/v13122371.
Florian A Lempp12, Imme Roggenbach1, Shirin Nkongolo123, Volkan Sakin1, Franziska Schlund1, Paul Schnitzler4, Heiner Wedemeyer5, Frédéric Le Gal6, Emmanuel Gordien6, Cihan Yurdaydin78, Stephan Urban12
Department of Infectious Diseases, Molecular Virology, University Hospital Heidelberg, 69120 Heidelberg, Germany.
German Centre for Infection Research (DZIF), 69120 Heidelberg, Germany.
Toronto Centre for Liver Disease, University Health Network, Toronto, ON M5G 1L7, Canada.
Department of Infectious Diseases, Virology, University Hospital Heidelberg, 69120 Heidelberg, Germany.
Clinic for Gastroenterology and Hepatology, University Hospital Essen, 45147 Essen, Germany.
Laboratoire de Microbiologie Clinique, Hôpital Avicenne, APHP, 93000 Bobigny, France.
Department of Gastroenterology, University of Ankara, Ankara 06560, Turkey.
Department of Gastroenterology and Hepatology, Koç University Medical School, Istanbul 34450, Turkey.
Hepatitis Delta virus (HDV) is a satellite of the Hepatitis B virus (HBV) and causes severe liver disease. The estimated prevalence of 15-20 million infected people worldwide may be underestimated as international diagnostic guidelines are not routinely followed. Possible reasons for this include the limited awareness among healthcare providers, the requirement for costly equipment and specialized training, and a lack of access to reliable tests in regions with poor medical infrastructure. In this study, we developed an HDV rapid test for the detection of antibodies against the hepatitis delta antigen (anti-HDV) in serum and plasma. The test is based on a novel recombinant large hepatitis delta antigen that can detect anti-HDV in a concentration-dependent manner with pan-genotypic activity across all known HDV genotypes. We evaluated the performance of this test on a cohort of 474 patient samples and found that it has a sensitivity of 94.6% (314/332) and a specificity of 100% (142/142) when compared to a diagnostic gold-standard ELISA. It also works robustly for a broad range of anti-HDV titers. We anticipate this novel HDV rapid test to be an important tool for epidemiological studies and clinical diagnostics, especially in regions that currently lack access to reliable HDV testing.