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Accuracy of supplementary serologic testing for human T-lymphotropic virus
types I and II in US blood donors. Retrovirus Epidemiology Donor Study
MP Busch, M Laycock, SH Kleinman, JW Wages , M Calabro, JE Kaplan, RF Khabbaz and CG Hollingsworth
Irwin Memorial Blood Centers, San Francisco, CA 94118.
Blood donations in the United States have been screened for antibody to
human T-lymphotropic virus type I (HTLV-I) by HTLV-I enzyme immunoassay
(EIA) since November 1988. Specimens repeatedly found to be reactive by EIA
undergo confirmation by supplementary serologic tests. We assessed the
accuracy of blood center testing of 994 HTLV-I EIA repeat-reactive
specimens in five US blood centers between November 1988 and December 1991.
Of 410 confirmed HTLV-I/II donations, 407 (99.3%) were infected with
HTLV-I/II, as determined by polymerase chain reaction (PCR) (403 cases) and
by repeat serologic testing (4 cases). The three false- positive results
occurred in the first year of testing. Of 425 HTLV- indeterminate
specimens, 6 (1.4%) were found to be infected by PCR (5 with HTLV-II and 1
with HTLV-I). None of 159 confirmatory test-negative donations was PCR
positive. Of HTLV-I/II-seropositive specimens, 80.2% to 95.4% could be
typed as HTLV-I or HTLV-II by type-specific serologic assays. These results
support recommendations that HTLV-I/II- seropositive donors should be
advised that they are infected with HTLV- I, HTLV-II, or HTLV-I/II
(depending on results of type-specific assays). HTLV-indeterminate donors
should be advised that their results only rarely indicate HTLV infection.
HTLV confirmatory test-negative donors should be reassured that they are
not infected with HTLV-I or HTLV-II.
Volume 83,
Issue 4,
pp. 1143-1148,
02/15/1994
Copyright © 1994 by The American Society of Hematology
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