Simultaneous confirmation and differentiation of human T‐lymphotropic virus types I and II infection by modified western blot containing recombinant envelope glycoproteins

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Abstract
A modified Western blot (WB) that includes both shared (r21e) and unique recombinant envelope proteins from human T‐lymphotropic virus (HTLV) type I (rgp46I) and type II (rgp46II) was compared to conventional HTLV serologic tests in 379 United States blood donors and individuals residing in diverse geographic regions, and the specimens were categorized as positive (n = 158), indeterminate (n = 158), or negative (n = 63) for HTLV infection. Of the 158 HTLV‐I/II‐positive specimens (66 requiring radioimmunoprecipitation assay [RIPA] for confirmation), 156 reacted concordantly with r21e, gag, and either rgp46I or rgp46II, thus eliminating the need for RIPA in all but two specimens and yielding a test sensitivity of 98.7 percent. Of the 158 indeterminate and 63 negative specimens, none reacted with r21e and rgp46I or rgp46II, yielding a test specificity of 100 percent. Furthermore, analysis of an additional 184 consecutive specimens from a retrovirology reference laboratory demonstrated that the modified WB correctly identified 27 of 28 HTLV‐I specimens and all 13 HTLV‐II specimens, with a test sensitivity of 97.6 percent. None of specimens that were indeterminate or nonreactive in conventional WB and/or RIPA and none of the screening enzyme immunoassay‐negative specimens reacted with r21e and either rgp46I or rgp46II, for a test specificity of 100 percent. Thus, the modified WB appears to be highly sensitive and specific for simultaneous detection and discrimination of HTLV‐I from HTLV‐II and has the advantage of being a one‐step assay that is easily performed in all types of laboratory settings and allows rapid, reliable, and standardized testing for HTLV‐I/II infection.