New sensitive and specific assay for human immunodeficiency virus antibodies using labeled recombinant fusion protein and time-resolved fluoroimmunoassay

J Clin Microbiol. 1990 Sep;28(9):2022-9. doi: 10.1128/jcm.28.9.2022-2029.1990.

Abstract

A new, rapid method for the detection of human immunodeficiency virus type 1 (HIV-1) antibody by time-resolved fluoroimmunoassay (TR-FIA) was developed. In this assay format, microtitration strips were coated with a recombinant fusion protein, and the same protein was labeled with europium and added into the wells simultaneously with the test specimens. The recombinant fusion protein contained the HIV-1 p24 gag protein sequence that carried an insertion, near the carboxyl terminus, of a 23-amino-acid sequence from a highly conserved region of the HIV-1 gp41 envelope protein. This recombinant antigen enabled the detection of antibodies to both gag and env gene products. When this assay was compared with a commercially available recombinant enzyme-linked immunoabsorbent assay (ELISA) by using four quality-control panels, the TR-FIA detected all 20 positive specimens, while the recombinant ELISA detected only 16 of them. This increased sensitivity could be demonstrated directly by the assay of dilution series of HIV-1-positive sera. The analysis of two seroconversion panels by TR-FIA and six ELISAs showed that TR-FIA allowed detection of antibody in infected individuals 16 days earlier than the other assays did. In addition to being highly sensitive, the assay was highly specific; of the 57 samples shown to be repeatedly positive by ELISA but known to be HIV-1 negative by Western immunoblot analysis, only 1 sample reacted positively in this assay. The specificity of the assay was 99.9% when 1.054 random serum specimens were tested.

Publication types

  • Comparative Study

MeSH terms

  • Amino Acid Sequence
  • Blotting, Western
  • Enzyme-Linked Immunosorbent Assay
  • Evaluation Studies as Topic
  • Fluoroimmunoassay*
  • Gene Products, gag / immunology
  • HIV Antibodies / analysis*
  • HIV Antigens
  • HIV Core Protein p24
  • HIV-1 / immunology*
  • Humans
  • Molecular Sequence Data
  • Recombinant Fusion Proteins / immunology
  • Viral Core Proteins / immunology

Substances

  • Gene Products, gag
  • HIV Antibodies
  • HIV Antigens
  • HIV Core Protein p24
  • Recombinant Fusion Proteins
  • Viral Core Proteins