Detection of HIV-1 proviral DNA with the AMPLICOR HIV-1 DNA Test, version 1.5, following sample processing by the MagNA Pure LC instrument

J Clin Virol. 2006 Nov;37(3):195-8. doi: 10.1016/j.jcv.2006.08.001. Epub 2006 Sep 12.

Abstract

Background: The AMPLICOR HIV-1 DNA Test, version 1.5 (AMP HIV-1 DNA 1.5), is a new commercially available PCR assay for the detection of human immunodeficiency virus type 1 (HIV-1) proviral DNA in human whole blood.

Objective: This study evaluates the performance characteristics of the assay following automated sample processing by the MagNA Pure LC instrument (MP).

Study design: Analytical sensitivity and reproducibility were assessed by testing replicate HIV-1 DNA dilution panels over 5 days. Clinical sensitivity and specificity were studied among 28 HIV-1 DNA-positive clinical specimens, 60 specimens from healthy blood donors, and 63 specimens from HIV-1-seropositive patients with HIV-1 RNA plasma levels ranging from <50 to >100,000 copies/mL.

Results: Following MP sample processing, the assay yielded an analytical sensitivity (95% detection rate) of 66.3 copies/mL (95% CI, 50.7-106.8), with clinical sensitivity and specificity of 100%.

Conclusions: MP is a reliable, labor-saving platform capable of processing specimens for AMP HIV-1 DNA 1.5. When combined with MP sample processing, AMP HIV-1 DNA 1.5 is a sensitive and reproducible assay for the detection of HIV-1 DNA in clinical whole blood specimens. However, the current AMP HIV-1 DNA 1.5 kit configuration may result in inefficient utilization of reagents.

Publication types

  • Evaluation Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Child
  • Child, Preschool
  • DNA, Viral / blood*
  • DNA, Viral / isolation & purification
  • Electronic Data Processing
  • HIV-1 / genetics*
  • HIV-1 / isolation & purification
  • Humans
  • Infant
  • Middle Aged
  • Polymerase Chain Reaction / methods
  • Proviruses / isolation & purification*
  • Sensitivity and Specificity

Substances

  • DNA, Viral