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Aptima HIV-1 Quant Assay

• Thoughtfully designed with multiple levels of protection
against future HIV-1 mutations.
• Performs with excellent sensitivity and precision across a
wide linear dynamic range.
• Offers convenience and efficiency with superior automation
on the Panther system.
 
This assay is not available for sale in the US.
About
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
Performance

Excellent Sensitivity

The Aptima HIV-1 Quant Dx assay’s limit of detection in subtype B samples (3rd International WHO Standard) is 12 copies/mL. In other samples such as those from subtype F or Group N or Group O, the assay’s LOD is less than 9 copies/mL.

(All tables and figures in this section can be found in the Aptima HIV-1 Quant Dx package insert.)

Limit of Detection Using the 3rd Party HIV-1 WHO International Standard Limit of Detection Across HIV-1 Subtypes and Groups

Lower Limit of Quantitation

The Aptima HIV-1 Quant Dx assay’s lower limit of quantitation was established and verified using the strict CLSI guidelines. The LLoQ of the assay is set at the highest concentration of all subtypes tested: 30 copies/mL. In samples such as subtype B, F, CRF01_AE or Group N and O, the LLoQ is 15 copies/mL or less.

Verification of LLoQ by HIV-1 Subtype or Group

Linearity of the Aptima HIV-1 Quant Dx assay

Linearity Across the Dynamic Range

Linearity Across Groups and Subtypes

 

Reliable Quantitation

The Aptima HIV-1 Quant Dx assay offers precise quantitation across the linear range in addition to accurate quantitation.

Precision is maintained in samples with low-viremia with narrow CV of less than 10% in samples with 1.80 log copies/mL HIV-1.

Precision of the Aptima HIV-1 Quant Dx Assay

 

 

References
  1. CE_IVD Aptima HIV-1 Quant Dx package insert. San Diego, CA; Hologic, Inc., 2015.
  2. Metsch LRPereyra M, Messinger S, et al. HIV transmission risk behaviors among HIV-infected persons who are successfully linked to care. Clin Infect Dis 2008; 47:577–84.
Glossary
CLSI Clinical and Laboratory Standards Institute
LLoQ Lower Limit of Quantitation
LoD Limit of Detection
LTR Long Terminal Repeat
pol Polymerase