TY - JOUR
T1 - 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
AU - Germer, Jeffrey J.
AU - Gerads, Tara M.
AU - Mandrekar, Jayawant N.
AU - Mitchell, P. Shawn
AU - Yao, Joseph D.C.
N1 - Funding Information:
This work was supported in part by a grant from Roche Diagnostics Corp. (Indianapolis, IN), which also provided the MagNA Pure LC and AMPLICOR kits used in this study. The HIV-1 PCR Standard (# 4678) was obtained through the AIDS Research and Reference Reagent Program, DAIDS, NIAID, NIH: PCR Panel 001 submitted by Roche Molecular Systems, Inc. (Dr. Shirley Kwok and Dr. Cindy Christopherson). We thank Dr. Brent Seaton and Jan Calma of Focus Diagnostics, Inc. (Cypress, CA), for providing the HIV-1 DNA-positive specimens used in this work.
Copyright:
Copyright 2011 Elsevier B.V., All rights reserved.
PY - 2006/11
Y1 - 2006/11
N2 - 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.
AB - 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.
KW - AMPLICOR
KW - HIV-1
KW - MagNA Pure LC
KW - Proviral
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U2 - 10.1016/j.jcv.2006.08.001
DO - 10.1016/j.jcv.2006.08.001
M3 - Article
C2 - 16973410
AN - SCOPUS:33749639541
SN - 1386-6532
VL - 37
SP - 195
EP - 198
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
IS - 3
ER -