title: Detection of human immunodeficiency virus type 1 p24 antigen and plasma RNA: relevance to indeterminate serologic tests.
abstract: BACKGROUND
  Most enzyme immunoassay-reactive specimens producing indeterminate Western blot results belong to individuals who are not infected with human immunodeficiency virus type 1 (HIV-1). However, a small percentage may correspond to early seroconversion or advanced disease, at which stage partial reactivity on Western blot may be observed.
  
  
  METHODS
  To determine the utility of HIV-1 p24 antigen and cell-free RNA detection for the resolution of Western blot-indeterminate serologic results, several types of enzyme immunoassay-positive, sero-indeterminate specimens were analyzed. Samples were obtained from infected individuals at the time of seroconversion (n = 20), from patients with AIDS (n = 2), as specimens from clinical samples obtained for diagnostic testing (n = 57), from blood donors producing persistent indeterminate results (n = 47), and from random blood donors (n = 72).
  
  
  RESULTS
  HIV-1 p24 antigen was detected in 10 of 20 specimens collected from 9 of 12 individuals who seroconverted and in 2 of 2 AIDS patients. HIV-1 plasma RNA was positive in 22 of 22 samples from those 14 individuals. All of 57 diagnostic specimens and 47 samples obtained from persistently indeterminate donors were negative for HIV-1 p24 antigen and plasma HIV-1 RNA. One of 72 blood donor specimens was positive for HIV-1 plasma RNA and had borderline reactivity for p24 antigen.
  
  
  CONCLUSIONS
  The detection of plasma RNA appears to be sensitive and specific; negative test results may be used to identify false-positive serologic reactions. The detection of p24 antigen and plasma RNA can also be used to confirm HIV-1 infection in persons with indeterminate serologic results associated with early seroconversion or late-stage disease.
authors.affiliation: Department of Medical Research, Abbott Laboratories, Abbott Park, Illinois.
authors.forename: D R
authors.initials: DR
authors.lastname: Henrard
authors.forename: J
authors.initials: J
authors.lastname: Phillips
authors.forename: I
authors.initials: I
authors.lastname: Windsor
authors.forename: D
authors.initials: D
authors.lastname: Fortenberry
authors.forename: L
authors.initials: L
authors.lastname: Korte
authors.forename: C
authors.initials: C
authors.lastname: Fang
authors.forename: A E
authors.initials: AE
authors.lastname: Williams
mesh_terms: D015153:Blotting, Western; D005188:False Negative Reactions; D005189:False Positive Reactions; D016655:HIV Core Protein p24 / Q000032:analysis*; D015497:HIV-1 / Q000235:genetics; D006801:Humans; D007124:Immunoenzyme Techniques; D012367:RNA, Viral / Q000097:blood*
chemical_list: D016655:HIV Core Protein p24; D012367:RNA, Viral