title: In vitro evaluation of cytomegalovirus-specific hyperimmune globulins vs. standard intravenous immunoglobulins.
abstract: OBJECTIVE
  To evaluate standard intravenous immunoglobulin (IVIG) as an alternative to intravenous cytomegalovirus hyperimmune immunoglobulin (CMVIG) for prophylaxis and therapy of cytomegalovirus (CMV) disease, we measured the ELISA and neutralizing titres of CMV-specific antibodies in CMVIG and IVIG preparations.
  
  
  METHODS
  Anti-CMV-IgG ELISA and neutralizing titres (fibroblast-based test) in CMVIG CG (Cytogam®, n = 20), CMVIG CT (Cytotect® CP, n = 3), IVIG P (Privigen®, n = 32) and IVIG K/G (Kiovig®/Gammagard®, n = 5) were compared, and IgG subclasses 1-4 were determined by nephelometry.
  
  
  RESULTS
  Cytomegalovirus hyperimmune immunoglobulins contained more than fourfold higher CMV ELISA and CMV-neutralizing activity per gram of IgG than the standard IVIGs. Pooled data for all four products showed a significant correlation between anti-CMV-IgG ELISA and neutralizing titres (r = 0·93, P < 0·001). There was a good correlation between the IgG3 content and CMV-neutralizing antibodies amongst lots of CMVIGs (r = 0·91, P = 0·01), but this did not extend to the IVIGs. CMVIG CG contained the highest CMV-neutralizing activity (3497 ± 395 PEIU/g IgG) of any product tested.
  
  
  CONCLUSIONS
  The higher anti-CMV neutralization capacity of CMVIG per gram of IgG vs. standard IVIG suggests that standard IVIGs are not equivalent to or interchangeable with CMVIG.
authors.affiliation: CSL Behring, Bern, Switzerland.
authors.forename: S M
authors.initials: SM
authors.lastname: Miescher
authors.affiliation: CSL Behring, Bern, Switzerland.
authors.forename: T M
authors.initials: TM
authors.lastname: Huber
authors.affiliation: CSL Behring, Bern, Switzerland.
authors.forename: M
authors.initials: M
authors.lastname: Kühne
authors.affiliation: CSL Behring, Bern, Switzerland.
authors.forename: P
authors.initials: P
authors.lastname: Lieby
authors.affiliation: Division of Geographic Medicine and Infectious Diseases, Tufts Medical Center, Tufts University School of Medicine, Boston, MA, USA.
authors.forename: D R
authors.initials: DR
authors.lastname: Snydman
authors.affiliation: CSL Behring, King of Prussia, PA, USA.
authors.forename: J L
authors.initials: JL
authors.lastname: Vensak
authors.affiliation: CSL Behring, King of Prussia, PA, USA.
authors.forename: M
authors.initials: M
authors.lastname: Berger
mesh_terms: D000914:Antibodies, Viral / Q000032:analysis* / Q000276:immunology; D003587:Cytomegalovirus / Q000276:immunology; D003586:Cytomegalovirus Infections / Q000188:drug therapy / Q000821:virology; D004797:Enzyme-Linked Immunosorbent Assay; D006801:Humans; D007074:Immunoglobulin G / Q000032:analysis*; D007136:Immunoglobulins / Q000276:immunology* / Q000627:therapeutic use; D016756:Immunoglobulins, Intravenous / Q000276:immunology* / Q000627:therapeutic use
chemical_list: D000914:Antibodies, Viral; D007074:Immunoglobulin G; D007136:Immunoglobulins; D016756:Immunoglobulins, Intravenous; C045781:cytomegalovirus-specific hyperimmune globulin
keywords: antibodies; cytomegalovirus; hyperimmune globulin; immunoglobulins; neutralizing; transplantation