Serological confirmation of human T-lymphotropic virus type I infection in
healthy blood and plasma donors
DW Anderson, JS Epstein, TH Lee, MD Lairmore, C Saxinger, VS Kalyanaraman, D Slamon, W Parks, BJ Poiesz and LT Pierik
Center for Biologics Evaluation and Review, FDA, Bethesda, MD 20892.
We wished to develop criteria for serological confirmation of human T-
lymphotropic virus type I (HTLV-I) infection in healthy donors. Selected
serum or plasma samples reactive by HTLV-I enzyme immunosorbent assay or
gel-agglutination assays with at least one viral- specific band on Western
immunoblot (WIB) were tested in six laboratories by four WIBs and four
radioimmunoprecipitation assays (RIPAs) for antibodies to HTLV-I proteins
encoded by gag (p19 and p24), env (gp46 and/or gp61), and tax (p40x) genes.
One hundred forty-two donor sera were obtained from 38 Japanese, 69
American, and 35 Caribbean blood or plasma donors. Among these samples, WIB
assays appeared more sensitive to p24 antibodies, whereas RIPAs were
significantly more sensitive to gp61 antibodies. All sera (137) with gp61
antibodies had p24 antibodies. Of the 137 sera positive for p24 and gp61
antibodies, p19 antibodies were detected in 129 sera, and p40x antibodies
were detected in 108. In sera with p19 antibodies and antibodies to env- or
tax-encoded proteins, p24 antibodies were always present. Antibodies to
p40x were not found in the absence of gp61 antibodies. Virological evidence
of infection was found in seven American donors by lymphocyte coculture
(one HTLV-I, one HTLV-II) or by polymerase chain reaction (three HTLV-I,
two HTLV-II). Sera from all seven donors showed p24 and gp46 and/or gp61
antibodies. We suggest that seroreactivity to both p24 and gp46 and/or gp61
by WIB or RIPA or both are suitable criteria to confirm but not to
distinguish HTLV-I and HTLV-II infections.
Volume 74,
Issue 7,
pp. 2585-2591,
11/15/1989
Copyright © 1989 by The American Society of Hematology
