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

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

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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.

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* The Aptima SARS-CoV-2, Aptima Zika Virus, Aptima SARS-CoV-2/Flu and Panther Fusion SARS-CoV-2 assays have not been FDA cleared or approved: These tests have been authorized by FDA under an EUA for use by authorized laboratories; The Aptima and Panther Fusion SARS-CoV-2 assays have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; The Aptima Zika Virus assay has been authorized only for the detection of nucleic acid from Zika virus, not for any other viruses or pathogens; The Aptima SARS-CoV-2/Flu assay has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, influenza A virus, influenza B virus, and not for any other viruses or pathogens. The Aptima SARS-CoV-2, Panther Fusion SARS-CoV-2, and Aptima SARS-CoV-2/Flu assays are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. The Aptima Zika assay is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

 

† In development and not for sale.

 

‡ Follow local and state guidelines for waste disposal.

 

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