title: Prospective evaluation of amplification-boosted ELISA for heat-denatured p24 antigen for diagnosis and monitoring of pediatric human immunodeficiency virus type 1 infection.
abstract: The performance in pediatric human immunodeficiency virus type 1 (HIV-1) infection of a signal-amplification boosted ELISA for HIV-1 p24 antigen in plasma after heat-mediated immune complex dissociation was prospectively compared with polymerase chain reaction-based procedures. Diagnostic sensitivity and specificity of the p24 antigen test were 100% and 99.2%, respectively. Quantification revealed RNA in 85.7% and p24 antigen in 87.4% of 230 samples from 25 infected children. Concentrations of these indices in individual samples correlated (P<.0001). Introduction or modification of antiretroviral treatment showed concordant responses of RNA and p24 antigen in 39 (90.7%) of 43 instances. The treatment-induced changes in concentrations of RNA were higher than those of p24 antigen in 11 instances. In 1 instance, however, the concentration change of p24 antigen was greater than that of RNA (P=. 002). Variation of RNA concentrations was more marked than that of p24 antigen (P=.002). The p24 antigen test was equivalent to PCR for diagnosing and monitoring pediatric HIV-1 infection.
authors.affiliation: Pediatric Infectious Diseases Unit, Universitäts-Kinderklinik, CH-8032 Zurich, Switzerland. dnadal@kispi.unizh.ch
authors.forename: D
authors.initials: D
authors.lastname: Nadal
authors.forename: J
authors.initials: J
authors.lastname: Böni
authors.forename: C
authors.initials: C
authors.lastname: Kind
authors.forename: O E
authors.initials: OE
authors.lastname: Varnier
authors.forename: F
authors.initials: F
authors.lastname: Steiner
authors.forename: Z
authors.initials: Z
authors.lastname: Tomasik
authors.forename: J
authors.initials: J
authors.lastname: Schüpbach
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use; D002940:Circadian Rhythm; D004797:Enzyme-Linked Immunosorbent Assay / Q000379:methods; D016655:HIV Core Protein p24 / Q000097:blood*; D015658:HIV Infections / Q000097:blood / Q000175:diagnosis* / Q000188:drug therapy; D015497:HIV-1 / Q000302:isolation & purification*; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008991:Monitoring, Physiologic; D009500:Neutralization Tests; D016133:Polymerase Chain Reaction / Q000379:methods; D011446:Prospective Studies; D011489:Protein Denaturation; D012367:RNA, Viral / Q000097:blood; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D019562:Viral Load / Q000379:methods*
chemical_list: D019380:Anti-HIV Agents; D016655:HIV Core Protein p24; D012367:RNA, Viral