HCV false positive immunoassays in patients with LVAD: A potential trap! |
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| Affiliation: | 1. Microbiology Department, ULB—Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium;2. Cardiac Surgery Department, ULB—Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium;1. Comparative Tropical Medicine and Parasitology, Ludwig-Maximilians-Universität München, Leopoldstrasse 5, 80802 Munich, Germany;2. University of South Bohemia, Faculty of Science and Biology Centre of the ASCR, Parasitology Institute, České Budějovice, Czech Republic;3. Onderstepoort Veterinary Institute, Private Bag X5, Onderstepoort 0110, South Africa;4. Department of Veterinary Tropical Diseases, Faculty of Veterinary Science, University of Pretoria, Private Bag X4, Onderstepoort 0110, South Africa;5. Department of Life and Consumer Sciences, College of Agriculture and Environmental Sciences, Unisa, Private Bag X06, Florida 1710, South Africa;6. The Pirbright Institute, Pirbright Laboratory, Ash Road, Pirbright, Surrey GU24 0NF, UK;7. Departamento de Medicina Veterinária Preventiva, Escola de Veterinária-UFMG, Belo Horizonte, Minas Gerais, Brazil;1. Heart Care Foundation Onlus, Florence, Italy;2. Department of Cardiovascular Research, Istituto di Ricovero e Cura a Carattere Scientifico, Istituto di Ricerche Farmacologiche Mario Negri, Milan, Italy;3. Centro Cardiologico Monzino, Milan, Italy;4. Servizio di Ricerca Cardiovascolare, Cardiocentro Ticino, Lugano, Switzerland;5. Department of Cardiology, Ospedale Policlinico, Modena, Italy;6. Department of Cardiology, Santa Croce Hospital, Fano, Italy;7. Fondazione Toscana Gabriele Monasterio, Stabilimento di Massa, Unità Operativa Adult Cardiology, Massa, Italy;8. Department of Cardiology, Nuovo Ospedale Versilia, Lido di Camaiore, Italy;9. Department of Cardiology, Ospedale Civile A. Murri, Fermo, Italy;10. Istituto di Fisiologia Clinica-Consiglio Nazionale delle Ricerche, Fondazione Toscana G. Monasterio, S.A. Emodinamica, Pisa, Italy;11. Associazione Nazionale Medici Cardiologi Ospedalieri Research Center, Florence, Italy;1. Centers for Disease Control and Prevention 1600 Clifton Rd NE Mailstop E46, Atlanta, GA 30333, USA;2. David Axelrod Institute, Wadsworth Center NYS Department of Health, PO Box 22002, Albany, NY 12201-2002, USA;1. Department of Infectious Diseases, Infection Control and Employee Health, The University of Texas MD Anderson Cancer Center, Houston, TX;2. Department of Stem Cell Transplantation and Cellular Therapy, The University of Texas MD Anderson Cancer Center, Houston, TX;3. Department of Gastroenterology, Hepatology, and Nutrition, The University of Texas MD Anderson Cancer Center, Houston, TX;4. Department of General Internal Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX;4. Departments of Clinical Virology, New Delhi, India;1. Departments of Transplantation and HPB Surgery, New Delhi, India;2. Departments of Pathology, New Delhi, India;3. Departments of Clinical Research, Institute of Liver and Biliary Sciences, New Delhi, India |
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| Abstract: | BackgroundLeft ventricular assist devices (LVAD) are a therapeutic choice for patients with advanced heart failure prior cardiac transplantation. Patients with a LVAD implant are frequently monitored for hepatitis C virus (HCV) as a positive result may be an exclusion criterion for transplantation.ObjectivesTo determine the rate of false positive results with immunoassays for HCV antibodies in a LVAD population.Study designBetween June 2011 and January 2015, HCV antibody testing using a chemiluminescent immunoassay (CLIA) (Liaison, Diasorin) was performed for 32 patients prior and post LVAD implantation. A HCV reactive result by CLIA was repeated and further tested by an enzyme linked fluorescent assay (ELFA) (VIDAS, bioMérieux). For patients with a positive HCV CLIA and ELFA test, immunoblot and HCV RNA detection were performed.ResultsPrior to LVAD implantation, all patients showed a negative HCV serology. After LVAD implantation, 19 patients (59%) had positive results for HCV antibody using CLIA and ELFA technologies. The HCV immunoblot was negative for 17 patients and indeterminate for two patients. For 15 patients, HCV RNA detection was performed and was undetectable. Actually, no HCV infections were observed among those who were tested for HCV RNA.ConclusionsHCV serological tests routinely used in our laboratories are not reliable in patients with cardiac devices. A positive CLIA and/or ELFA reaction in patients with a LVAD should be confirmed by HCV immunoblot and by HCV RNA PCR detection in order to rule out a HCV infection. |
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| Keywords: | HCV serology Left ventricular assist device False-positive |
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