Diagnosis of human immunodeficiency virus type 1 infection in infants by immune complex dissociation p24 assay

Using immune complex dissociation (ICD), we retrospectively examined serum and plasma of 206 infants aged 0 to 4 months who were perinatally exposed to human immunodeficiency virus (HIV). All samples were analyzed in a blinded manner. Infection status was determined based on the results of HIV culture and Centers for Disease Control and Prevention classification. The overall diagnostic sensitivity of the assay was 59% (93 samples, 73 infants), and specificity was 100% (160 samples, 133 infants). When the samples were analyzed according to age, sensitivity was highest at age 1 to 2 months (17 of 21 infants, 81%). Sensitivities at other ages were 53% at < 1 month, 55% at 2 to 3 months, and 48% at 3 to 4 months (9 of 17, 11 of 20, and 12 of 25 cases, respectively). In 11 evaluable cases there was a possible correlation of p24 antigen quantitation (in picograms per milliliter) with disease progression. We conclude that, as determined in this study, the ICD p24 is a rapid diagnostic assay for HIV infection with a sensitivity of > 80% at 1 to 2 months of age and 100% specificity, as evaluated, up to 4 months of age.