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

Background: The AMPLICOR(R) HIV-1 DNA Test, version 1.5 (AMP HTV-1 DNA 1.5), is a new commercially available PCR assay for the detection of human immunodeficiency virus type I (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 66.3copies/mL (95% Cl, 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. (C) 2006 Elsevier B.V. All rights reserved.