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 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).


METHODS
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.
Germer
Jeffrey J
JJ
Division of Clinical Microbiology, Mayo Clinic, 200 First Street SW, Rochester, MN 55905, United States.
Gerads
Tara M
TM
Mandrekar
Jayawant N
JN
Mitchell
P Shawn
PS
Yao
Joseph D C
JD
D000293:Adolescent; D000328:Adult; D000368:Aged; D002648:Child; D002675:Child, Preschool; D004279:DNA, Viral / Q000097:blood* / Q000302:isolation & purification; D001330:Electronic Data Processing; D015497:HIV-1 / Q000235:genetics* / Q000302:isolation & purification; D006801:Humans; D007223:Infant; D008875:Middle Aged; D016133:Polymerase Chain Reaction / Q000379:methods; D011533:Proviruses / Q000302:isolation & purification*; D012680:Sensitivity and Specificity
D004279:DNA, Viral