title: Comparative performances of an HTLV-I/II EIA and other serologic and PCR assays on samples from persons at risk for HTLV-II infection.
abstract: BACKGROUND
  HTLV-I and HTLV-II are related exogenous pathogenic human retroviruses. Until recently, ELISAs based on HTLV-I antigens have been used to screen for the presence of HTLV-I or -II antibodies. The HTLV-I-based assays have not been as sensitive in detecting antibodies to HTLV-II as in detecting antibodies to HTLV-I. The Abbott HTLV-I/HTLV-II ELISA uses a combination of HTLV-I and HTLV-II antigens to detect antibodies to the whole HTLV group. The performance of this ELISA was compared to that of several HTLV-I-based serologic assays and an HTLV-II PCR assay in cohorts of South American Indians and New York City IV drug users (IVDUs) in whom HTLV-II is endemic.
  
  
  METHODS
  Sera from 429 South American Indians and New York City IVDUs were evaluated for HTLV antibodies by the use of three ELISAs (rgp21-enhanced HTLV-I/II, Cambridge Biotech; Vironostika HTLV-I/II, Organon Teknika; and HTLV-I/HTLV-II, Abbott), and a Western blot (WB) assay. Peripheral blood leukocyte DNA from each person was analyzed for HTLV-I and HTLV-II pol DNA via PCR. The HTLV-II PCR-positive samples were further subtyped via cloning and sequencing and/or oligomer restriction.
  
  
  RESULTS
  Two hundred four samples (48%) were positive for HTLV-II by serologic and/or PCR assays. All of the positive samples from the Indians and approximately one-third of the positive samples from the IVDUs were of the HTLV-IIB subtype. Comparative analyses indicate that the sensitivity and specificity of the various assays were: PCR, 98 and 100 percent; Abbott HTLV-I/HTLV-II, 78 and 95 percent; Cambridge Biotech HTLV-I/II, 76 and 96 percent; Vironostika HTLV-I/II, 71 and 98 percent; and WB, 73 and 100 percent, respectively.
  
  
  CONCLUSIONS
  There were no significant differences among the sensitivities and specificities of the HTLV-I/II ELISAs (p values, 0.056-0.438). The WB and PCR assays were much more specific than the other serologic assays (p</=0.03). However, the PCR assay is significantly (p<0.001) more sensitive than any of the serologic assays in the detection of HTLV-II infection. Thus, optimal detection of HTLV-II infection would seem to require both serologic and DNA PCR assays.
authors.affiliation: Department of Medicine, State University of New York, Health Science Center, Syracuse, New York 13210, USA. poieszb@mailbox.hscsyr.edu
authors.forename: B J
authors.initials: BJ
authors.lastname: Poiesz
authors.forename: S
authors.initials: S
authors.lastname: Dube
authors.forename: D
authors.initials: D
authors.lastname: Choi
authors.forename: E
authors.initials: E
authors.lastname: Esteban
authors.forename: J
authors.initials: J
authors.lastname: Ferrer
authors.forename: M
authors.initials: M
authors.lastname: Leon-Ponte
authors.forename: G E
authors.initials: GE
authors.lastname: de Perez
authors.forename: J
authors.initials: J
authors.lastname: Glaser
authors.forename: S G
authors.initials: SG
authors.lastname: Devare
authors.forename: A S
authors.initials: AS
authors.lastname: Vallari
authors.forename: G
authors.initials: G
authors.lastname: Schochetman
mesh_terms: D004797:Enzyme-Linked Immunosorbent Assay; D015481:HTLV-I Antibodies / Q000276:immunology*; D015482:HTLV-II Antibodies / Q000276:immunology*; D015491:HTLV-II Infections / Q000235:genetics*; D006801:Humans; D016133:Polymerase Chain Reaction; D013223:Statistics as Topic
chemical_list: D015481:HTLV-I Antibodies; D015482:HTLV-II Antibodies