title: Improved detection of HCV Infection in hemodialysis patients using a new HCV RNA qualitative assay: experience of a transplant center.
abstract: BACKGROUND
  Hepatitis C virus (HCV) is frequently a silent infection in hemodialysis (HD) patients with a prevalence of 8-10%. Improving HCV detection in this population prior to transplantation is critical both for infection control and optimal patient care.
  
  
  OBJECTIVE
  To assess the current HCV testing practice of the National Institute for Transplantation (PCR testing of enzyme immunoassay (EIA) positive HD patients) by evaluating a subset of EIA positive and EIA negative samples with the VERSANT HCV RNA Qualitative Assay based on transcription mediated amplification (HCV Qual (TMA)) (sensitivity < or = 9.6 IU/ml) and in-house PCR (HCV Qual (PCR)) (sensitivity approximately 149 IU/ml).
  
  
  METHODS
  2321 HD patients were screened by Abbott HCV EIA 2.0. A subset of 80/169 E IA positive samples and 100/2152 EIA negative samples were tested by both assays. TMA/PCR discordant samples were genotyped.
  
  
  RESULTS
  PCR and TMA gave concordant results in 67/80 (83.8%) of EIA positive samples. 11/80 (14.7%) were reactive by HCV Qual (TMA), but not by HCV Qual (PCR); 2/80 (2.7%) were reactive by HCV Qual (PCR), but not by HCV Qual (TMA). 2/100 (2%) EIA negative samples were reactive and 95/100 (95%) were non-reactive by both assays. Three (3%) were only HCV Qual (TMA) reactive. 11/14 TMA+/PCR-samples with sufficient volume were genotyped.
  
  
  CONCLUSIONS
  HCV Qual (TMA) identified active HCV infection in more EIA positive and EIA negative patients than HCV Qual (PCR) and should be part of our testing algorithm.
authors.affiliation: National Institute of Transplantation, Los Angeles, CA, USA.
authors.forename: Nasreen
authors.initials: N
authors.lastname: Khan
authors.forename: Sali
authors.initials: S
authors.lastname: Aswad
authors.forename: Hamid
authors.initials: H
authors.lastname: Shidban
authors.forename: Mehbobeh
authors.initials: M
authors.lastname: Aghajani
authors.forename: Ralph
authors.initials: R
authors.lastname: Mendez
authors.forename: Robert
authors.initials: R
authors.lastname: Mendez
authors.forename: Lorraine
authors.initials: L
authors.lastname: Comanor
mesh_terms: D005838:Genotype; D016174:Hepacivirus / Q000235:genetics / Q000302:isolation & purification*; D006526:Hepatitis C / Q000175:diagnosis* / Q000453:epidemiology; D006801:Humans; D016030:Kidney Transplantation; D016133:Polymerase Chain Reaction / Q000379:methods; D012367:RNA, Viral / Q000097:blood*; D006435:Renal Dialysis / Q000009:adverse effects*; D012680:Sensitivity and Specificity; D014850:Waiting Lists
chemical_list: D012367:RNA, Viral