title: Sensitivity and specificity of four assays to detect human T-lymphotropic virus type I or type I/II antibodies.
abstract: BACKGROUND
  Assays that detect human T-lymphotropic virus type I and type II antibody (HTLV-I/II) are widely used in the routine screening of blood donors.
  
  
  METHODS
  Four commercially available anti-HTLV-I (Fujirebio and Organon Teknika) or -HTLV-I/II assays (Murex and Ortho) were evaluated in various serum panels: A) HTLV-I-positive specimens (n = 41), confirmed by Western blot and polymerase chain reaction; B) a commercially available anti-HTLV-I/II panel; C) serial dilutions of sera from HTLV-I-positive individuals (n = 30), confirmed by immunofluorescence assay and Western blot: D) serial dilutions of HTLV-II-positive blood donors (n = 20), confirmed by Western blot and polymerase chain reaction, and E) sera from first-time blood donors (n = 1055).
  
  
  RESULTS
  All four assays elicited reactions in all 82 HTLV-I-positive samples in Panels A, B, and C. Of 32 HTLV-II-positive specimens in Panels B and D, 31 (96.9%) reacted in the Organon Teknika assay and all 32 reacted in the remaining tests. Probit analysis of test results in Panels C and D indicated that the Fujirebio test was the most sensitive assay, followed by Organon Teknika, Ortho, and Murex. The specificities of Fujirebio, Murex, Organon Teknika, and Ortho tests in 1055 first-time blood donors were 99.9, 100, 99.6, and 99.9 percent, respectively.
  
  
  CONCLUSIONS
  All four studied assays for detecting HTLV-I or HTLV-I/II antibodies are appropriate as screening tests.
authors.affiliation: Red Cross Blood Bank, Amsterdam, The Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Vrielink
authors.forename: H W
authors.initials: HW
authors.lastname: Reesink
authors.forename: H L
authors.initials: HL
authors.lastname: Zaaijer
authors.forename: C L
authors.initials: CL
authors.lastname: van der Poel
authors.forename: H T
authors.initials: HT
authors.lastname: Cuypers
authors.forename: P N
authors.initials: PN
authors.lastname: Lelie
mesh_terms: D001782:Blood Donors; D015153:Blotting, Western; D005260:Female; D015481:HTLV-I Antibodies / Q000097:blood*; D006801:Humans; D007118:Immunoassay; D008297:Male; D016133:Polymerase Chain Reaction; D012680:Sensitivity and Specificity
chemical_list: D015481:HTLV-I Antibodies