The Aptima HIV-1 Quant assay is an in vitro nucleic acid amplification test for' the
quantitation of HIV-1 RNA on the fully automated Panther' system. It is intended for
use as an aid in clinical management of patients' infected with HIV-1.'
• A dual target approach against highly conserved regions in the HIV'genome, pol
and LTR; a sophisticated primer design; and redundancy'of oligonucleotides for
protection against mutations.
• Thorough verification of performance parameters such as LoD, LLoQ, and' linearity
across groups M, N and O with well-designed studies using the' latest CLSI
guidelines.
• Excellent precision in quantitation of low viremia.
Monitoring HIV-1 infected patients
The Aptima HIV-1 Quant assay may be'used as an aid in monitoring the effect of
antiretroviral treatment by measuring changes in the concentration of HIV-1 RNA in
plasma. When used as an aid in'monitoring the effect of antiretroviral therapy,
performance for quantitative results' is established with plasma specimens only.
Serum specimens may not be used for'quantitative results. This assay is not
intended for use in screening blood or'plasma