Sensitivity and specificity of four assays to detect human T-lymphotropic virus type I or type I/II antibodies

Transfusion. 1996 Apr;36(4):344-6. doi: 10.1046/j.1537-2995.1996.36496226150.x.


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.

Study design and 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.

Conclusion: All four studied assays for detecting HTLV-I or HTLV-I/II antibodies are appropriate as screening tests.

MeSH terms

  • Blood Donors
  • Blotting, Western
  • Female
  • HTLV-I Antibodies / blood*
  • Humans
  • Immunoassay
  • Male
  • Polymerase Chain Reaction
  • Sensitivity and Specificity


  • HTLV-I Antibodies