title: Sensitivity of two hepatitis B virus, hepatitis C virus (HCV), and human immunodeficiency virus (HIV) nucleic acid test systems relative to hepatitis B surface antigen, anti-HCV, anti-HIV, and p24/anti-HIV combination assays in seroconversion panels.
abstract: BACKGROUND
  Accurate determination of the infectious window period (IWP) that remains with individual-donation (ID) or minipool (MP) NAT compared to those with serology assays is essential for residual risk estimations.
  
  
  METHODS
  The relative sensitivity of the Procleix Tigris system (Gen-Probe/Chiron) used in ID-NAT format and cobas s 201 (Roche Molecular Systems) applied in 1:6 diluted samples to mimic six-minipool (MP6) nucleic acid test (NAT) was assessed by quadruplicate testing of five seroconversion panels per marker. A mathematical analysis based on the log-linear increase of viremia in the ramp-up phase, as established with bDNA 3.0 assays enabled estimation of the IWP for human immunodeficiency virus (HIV) and hepatitis B virus (HBV) assays.
  
  
  RESULTS
  The mean IWPs were Tigris HIV RNA 5.5 days, s 201 (1:6) HIV RNA 7.4 days, GenScreen Plus p24/anti-HIV 17.8 days, PRISM anti-HIV 19.0 days, Tigris HBV DNA 20.6 days, s 201 (1:6) HBV DNA 22.6 days, Bio-Rad hepatitis B surface antigen (HBsAg) 37.8 days, and PRISM HBsAg 35.5 days. At estimated 50 percent NAT seroconversion rates, s 201 (1:6) and Tigris showed mean window-period reduction times (WPRTs) of 30.5 to 35.5 days to hepatitis C virus antibody (anti-HCV) assays, 10.4 to 13.5 days to anti-HIV, or combination p24/anti-HIV assays and 12.8 to 17.2 days to HBsAg assays.
  
  
  CONCLUSIONS
  Tigris ID-NAT detected HIV RNA 2 days earlier than s 201 MP6-NAT, but the difference in sensitivity between the two NAT systems was not significant in HBV seroconversion panels. Insufficient seroconversion samples were available for reliable modeling of WPRT in early HCV infection, but 1.4 to 2.0 days could be predicted by translating analytical sensitivity data. Both multiplex NAT systems demonstrate significant WPRTs compared to (combined) antigen and antibody assays.
authors.affiliation: Etablissement Français du Sang , La Plaine Saint Denis, France. azzedine.assal@efs.sante.fr
authors.forename: Azzedine
authors.initials: A
authors.lastname: Assal
authors.forename: Valérie
authors.initials: V
authors.lastname: Barlet
authors.forename: Marie
authors.initials: M
authors.lastname: Deschaseaux
authors.forename: Isabelle
authors.initials: I
authors.lastname: Dupont
authors.forename: Pierre
authors.initials: P
authors.lastname: Gallian
authors.forename: Cathy
authors.initials: C
authors.lastname: Guitton
authors.forename: P
authors.initials: P
authors.lastname: Morel
authors.forename: Harry
authors.initials: H
authors.lastname: van Drimmelen
authors.forename: Bernard
authors.initials: B
authors.lastname: David
authors.forename: Nico
authors.initials: N
authors.lastname: Lelie
authors.forename: Philippe
authors.initials: P
authors.lastname: De Micco
mesh_terms: D004279:DNA, Viral / Q000097:blood; D006678:HIV / Q000235:genetics*; D016174:Hepacivirus / Q000235:genetics*; D006514:Hepatitis B Surface Antigens / Q000097:blood*; D006515:Hepatitis B virus / Q000235:genetics*; D006801:Humans; D021141:Nucleic Acid Amplification Techniques; D012367:RNA, Viral / Q000097:blood; D012044:Regression Analysis; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012698:Serologic Tests / Q000379:methods*; D013997:Time Factors; D014766:Viremia / Q000097:blood
chemical_list: D004279:DNA, Viral; D006514:Hepatitis B Surface Antigens; D012367:RNA, Viral