Characterization of the third generation enzyme immunoassay IEA-HIV1/2-IIIfor the detection of anti-HIV specific antibodies in human sera

The sensitivity and specificity of the developed anti-HTV1/2 third generati on enzyme immunoassay, the IEA-HIV1/2-III, was examined. The test system fo r the detection of anti-HIV antibodies included peroxidase-conjugated HIV-s pecific recombinant Gag protein fragments (epitopes of p24 and p17 proteins ), Env-1 (epitopes of p41 and p120 proteins), and Env-2 (p36 epitopes). Sen sitivity was evaluated with 346 sera from HIV1-seropositive subjects, Anti- HIV1 Low Titer panels no.10 and PRE-106 and seropositive panel PRE-931 in c om-parison with other third- and second-generation assays. The IEA-HIV1/2-I II assays are characterized with high sensitivity comparable to the other t hird generation assays and the better sensitivity with respect to the secon d generation test-kit to determine HIV-specific antibodies in human sera. T he specificity was determined using three hundred sixty-seven potentially c ross-reactive samples (but negative for anti-HIV1/2). Only one specimen amo ng them was reactive by IEA-HIV1/2-III.