Epidemiologic assessment of screening tests for antibody to human T lymphotropic virus type I (HTLV-I).

We tested 196 sera from a human T lymphotropic virus type I (HTLV-I) risk group (prostitute women) with two commercial "research" enzyme-linked immunoabsorbent assays (EIA) for HTLV-I antibodies. All tested sera were characterized by HTLV-I Western immunoblots and by HTLV-I radioimmunoprecipitation assays. The estimated sensitivities of the EIA tests were 93.8 percent and 100 percent, and the specificities were 98.8 percent and 95.8 percent, respectively, using recommended criteria for seropositivity (requiring reactivity to both gag p24 and env gp46 or gp61/68). Calculated negative predictive values remained excellent (greater than 99.9 percent and 100 percent, respectively) at lower seroprevalence rates but the positive predictive values were only 7.3 percent and 2.3 percent when calculated for a seroprevalence rate of 0.1 percent. These results emphasize the importance and need for additional HTLV-I supplementary serologic testing when screening populations with low HTLV-I seroprevalence rates.