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Aptima HIV-1 Quant Assay (US-IVD)

The Aptima HIV-1 Quant assay is an FDA approved viral load assay intended for use in conjunction with clinical presentation and other laboratory markers for disease prognosis and for use as an aid in monitoring the effects of antiretroviral treatment, as measured by changes in plasma HIV-1 RNA levels.

  • Provides multiple levels of protection against  HIV-1 mutations.

  • Performs with excellent sensitivity and precision across a wide linear dynamic range.

  • Offers convenience and efficiency with total automation on the Panther system.

 

Please contact your local sales representative for product availability.

About

The Aptima HIV-1 Quant assay is an in vitro nucleic acid amplification test (NAAT) for the quantitation of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from HIV-1 infected individuals on the fully automated Panther® system. The Aptima HIV-1 Quant assay quantitates HIV-1 RNA groups M, N, and O over the range of 30 to 10,000,000 copies/mL. One international unit is equivalent to 0.35 copies of HIV-1 RNA for the WHO 3rd International Standard for 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 of HIV infected patients

In conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals, 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.  This assay is not intended for used as a donor screening test for HIV-1 or as a diagnostic test to confirm the presence of HIV-1 infection. 

 

Performance
Excellent sensitivity

The limit of detection (LoD) is defined as the concentration of HIV-1 RNA that is detected at 95% or greater probability according to CLSI EP17-A2 (37). The Aptima HIV-1 Quant assay’s LoD in subtype B samples (3rd International WHO Standard) is 12 copies/mL.

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 assay’s lower limit of quantitation (LLoQ) 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.

 

Verification of the LLoQ by HIV-1 Subtype or Group

 
Linearity of the Aptima HIV-1 Quant Assay

 

Linearity Across the Dynamic Range

Linearity Across Groups and Subtypes

 

Reliable Quantitation

The Aptima HIV-1 Quant 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 Quant Assay

CV=coefficient of variation, SD=standard deviation

a This panel member was diluted 1:3 with specimen diluent and tested to evaluate the precision of the diluted sample.

Note: Variability from some factors may be numerically negative, which can occur if the variability due to those factors is very small. When this occurs, SD=0 and CV=0%. The total number of replicates tested was 162 for each panel; only replicates with a numerical value were analyzed.

 

Diagnostic Performance

 

Correlation Between Aptima HIV-1 Quant Assay and Comparator Assay

 

 

 

References

1. Aptima HIV-1 Quant Assay [package insert]. AW-13242-001. San Diego, CA; Hologic, Inc., 2017.

Glossary

CLSI

Clinical and Laboratory Standards Institute

LLoQ

Lower Limit of Quantitation

LoD

Limit of Detection

LTR

Long Terminal Repeat

pol

Polymerase