title: HCV false positive immunoassays in patients with LVAD: A potential trap!
abstract: BACKGROUND
  Left 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.
  
  
  OBJECTIVE
  To determine the rate of false positive results with immunoassays for HCV antibodies in a LVAD population.
  
  
  METHODS
  Between 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.
  
  
  RESULTS
  Prior 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.
  
  
  CONCLUSIONS
  HCV 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.
authors.affiliation: Microbiology Department, ULB-Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium. Electronic address: amelie.heinrichs@ulb.ac.be.
authors.forename: Amélie
authors.initials: A
authors.lastname: Heinrichs
authors.affiliation: Cardiac Surgery Department, ULB-Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium.
authors.forename: Martine
authors.initials: M
authors.lastname: Antoine
authors.affiliation: Microbiology Department, ULB-Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium.
authors.forename: Deborah
authors.initials: D
authors.lastname: Steensels
authors.affiliation: Microbiology Department, ULB-Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium.
authors.forename: Isabel
authors.initials: I
authors.lastname: Montesinos
authors.affiliation: Microbiology Department, ULB-Hôpital Erasme, Route de Lennik 808, 1070 Brussels, Belgium.
authors.forename: Marie-Luce
authors.initials: ML
authors.lastname: Delforge
mesh_terms: D005189:False Positive Reactions; D006353:Heart-Assist Devices / Q000009:adverse effects*; D016174:Hepacivirus / Q000276:immunology; D006526:Hepatitis C / Q000175:diagnosis* / Q000473:pathology*; D018937:Hepatitis C Antibodies / Q000097:blood; D006801:Humans; D007118:Immunoassay / Q000379:methods*; D012698:Serologic Tests / Q000379:methods*; D018487:Ventricular Dysfunction, Left / Q000628:therapy*
chemical_list: D018937:Hepatitis C Antibodies
keywords: False-positive; HCV serology; Left ventricular assist device