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:

  • 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.

  • 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

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

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Lower Limit of Quantitation (LLoQ): The Aptima HIV-1 Quant Dx assay reports HIV-1 viral load as low as 30 copies/mL.1

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Broad linear range.

The Aptima HIV-1 Quant Dx assay accurately quantifies HIV-1 RNA, from 30 to 10 million copies/mL.1

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Repeatable, reliable results.

The Aptima HIV-1 Quant Dx assay delivers high precision in quantitation, with a narrow coefficient of variation across the linear range—including in low-viremia samples—for results you can trust.1

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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

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The LLoQ has been thoroughly established and verified across HIV-1 groups M, N, and O.1,2

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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:

  • 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.

  • Sophisticated primer design—including length—to tolerate mutations.

  • Redundant oligonucleotides for additional protection.

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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.