Multicenter evaluation of a new, automated enzyme-linked immunoassay for detection of human immunodeficiency virus-specific antibodies and antigen.

A collaborative multicenter study was conducted to evaluate the sensitivity, specificity, and precision of a three-step, fully automated, qualitative microparticle-based enzyme-linked immunoassay (AxSYM HIV Ag/Ab Combo; Abbott Laboratories), designed to simultaneously detect (i). antibodies against human immunodeficiency virus type 1 (HIV-1) and/or type 2 (HIV-2) and (ii). HIV p24 antigen. A significant reduction in the HIV seroconversion window was achieved by combining detection of HIV antibodies and antigen into a single assay format. For 22 selected, commercial HIV seroconversion panels, the mean time of detection with the combined-format HIV antigen-antibody assay was reduced by 6.15 days compared to that with a similar third-generation single-format HIV antibody assay. The quantitative sensitivity of the combination assay for the p24 antigen (17.5 pg/ml by use of the p24 quantitative panel VIH SFTS96') was nearly equivalent to that of single-format antigen tests. The combination assay demonstrated sensitive (100%) detection of anti-HIV immunoglobulin in specimens from individuals in CDC stages A, B, and C and from individuals infected with different HIV-1 group M subtypes, group O, or HIV-2. The apparent specificity for hospitalized patients (n = 1938) was 99.90%. In a random population of 7900 volunteer blood donors, the specificity (99.87%) was comparable to that of a third-generation single-format HIV antibody assay (99.92%) on the same donor specimens. In addition, the combination assay was robust to potential interfering specimens. The precision of the combination was high, with intra- and interrun variances of <or=9.3% for each precision panel specimen or assay control and <or=5.3% for the negative assay control.
AuthorsEva Sickinger, Myriam Stieler, Boris Kaufman, Hans-Peter Kapprell, Daniel West, Arnold Sandridge, Sushil Devare, Gerald Schochetman, J C Hunt, David Daghfal,
JournalJournal of clinical microbiology (J Clin Microbiol) Vol. 42 Issue 1 Pg. 21-9 (Jan 2004) ISSN: 0095-1137 [Print] United States
PMID14715727 (Publication Type: Journal Article, Multicenter Study)
Chemical References
  • HIV Antibodies
  • HIV Core Protein p24
  • Enzyme-Linked Immunosorbent Assay (methods)
  • HIV Antibodies (blood)
  • HIV Core Protein p24 (blood)
  • HIV-1 (immunology)
  • HIV-2 (immunology)
  • Humans
  • Sensitivity and Specificity

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