
A New Standard in HIV-1 Confirmation and Viral Load Monitoring
FIRST and ONLY Dual Claim HIV-1 Assay
The Aptima HIV-1 Quant Dx Assay is intended for use:
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To confirm HIV-1 infection in an individual whose plasma or serum specimen is reactive with an approved assay with an indication as an aid in the diagnosis of HIV-1 infection.
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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
Performance You Can Count On
Explore the Aptima HIV-1 Quant Dx Assay
A highly sensitive assay for reliable quantitation of HIV-1 RNA.
Limit of Detection (LoD): The Aptima HIV-1 Quant Dx assay can detect HIV-1 RNA as low as 12 copies/mL using a 0.5-mL sample.1
Lower Limit of Quantitation (LLoQ): The Aptima HIV-1 Quant Dx assay reports HIV-1 viral load as low as 30 copies/mL.1
Ensures HIV-1 can be accurately quantified across major groups and subtypes.
The LoD has been thoroughly verified across HIV-1 groups M, N, and O with multiple replicates and multiple reagent lots.1
The LLoQ has been thoroughly established and verified across HIV-1 groups M, N, and O.1,2
Thoughtful assay design to guard against mutations.
The Aptima HIV-1 Quant Dx assay provides 3 levels of protection for confidence in assay performance despite drug selection pressures and growing genetic diversity3:
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Dual-target approach for built-in redundancy, with both targets chosen within highly conserved genomic regions of HIV-1 (LTR and pol) to ensure accurate quantitation.
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Sophisticated primer design—including length—to tolerate mutations.
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Redundant oligonucleotides for additional protection.
Ordering information
References
1. Aptima HIV-1 Quant Dx assay. US package insert AW-18107. Hologic, Inc.; 2020.
2. Manak M. Evaluation of the Hologic (Gen-Probe) Aptima HIV-1 RT quantitative assay on HIV-1 subtypes. Paper presented at: The 21st Conference on Retroviruses and Opportunistic Infections; March 3-6, 2015; Boston, MA.
3. Data on file. Hologic, Inc., 2015.