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

Jeffrey J. Germer, Tara M. Gerads, Jayawant Mandrekar, P. Shawn Mitchell, Joseph D C Yao

Research output: Contribution to journalArticle

10 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)195-198
Number of pages4
JournalJournal of Clinical Virology
Volume37
Issue number3
DOIs
StatePublished - Nov 2006

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HIV-1
DNA
Adenosine Monophosphate
Sensitivity and Specificity
Blood Donors
RNA
Polymerase Chain Reaction

Keywords

  • AMPLICOR
  • HIV-1
  • MagNA Pure LC
  • Proviral

ASJC Scopus subject areas

  • Applied Microbiology and Biotechnology
  • Virology
  • Immunology and Allergy
  • Infectious Diseases

Cite this

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. / Germer, Jeffrey J.; Gerads, Tara M.; Mandrekar, Jayawant; Mitchell, P. Shawn; Yao, Joseph D C.

In: Journal of Clinical Virology, Vol. 37, No. 3, 11.2006, p. 195-198.

Research output: Contribution to journalArticle

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abstract = "Background: The AMPLICOR{\circledR} 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.",
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