کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
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3370132 | 1219067 | 2006 | 4 صفحه PDF | دانلود رایگان |

BackgroundThe 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.ObjectiveThis study evaluates the performance characteristics of the assay following automated sample processing by the MagNA Pure LC instrument (MP).Study designAnalytical 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.ResultsFollowing 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%.ConclusionsMP 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.
Journal: Journal of Clinical Virology - Volume 37, Issue 3, November 2006, Pages 195–198