Aptima™ HIV-1 Quant Dx Assay

High sensitivity and excellent precision for Human Immunodeficiency Virus 1 (HIV-1) viral load monitoring.1

Hologic Aptima™ HIV-1 Quant Dx Assay in white background




    Reliable Quantitation1

    Deliver reliable, repeatable results with a robust dual-target assay that accurately detects and monitors HIV-1. Running the Aptima HIV-1 Quant DX assay on the Panther® System combines assay performance and excellent automation for viral load monitoring--a combination that delivers sample-to-result within a single integrated instrument.1

    High Accuracy & Precision

    The Aptima HIV Quant Dx assay is highly accurate for HIV-1 across the dynamic range of the assay.1-2

    Efficient Workflow & Flexible Processing

    No need for aliquoting or manual sample transfer. PPT, ACD and EDTA tubes are all validated.1 You can run multiple tests from a single sample. No manual sample preparation with primary tube loading to maintain positive sample identification.

    Random Access & Rapid Turnaround Time

    No more batching. You can run different test orders from the same sample as they arrive at the laboratory. Rapid turnaround time with first results in just 2 hours, 41 minutes. Prioritises STAT results.3

    Automated Analysis & Dilution Factor

    Automated QC analysis with Levey-Jennings plots to track and trend controls. Low sample volume option (240 μL) with automated dilution factor. Enables application of an automatic dilution factor instead of manual calculations.3

    Simplify & Scale the Future of Diagnostics

    The Aptima HIV-1 Quant Dx Assay is part of the Hologic Molecular Scalable Solution, a portfolio combining a broad, high-performing assay menu with high-throughput automation. Designed to flexibly scale to meet your needs, from a single-patient rapid result to population-level screening.

    Woman in front of Panther Machine as part of Hologic Molecular Scalable Solution

    Excellent Sensitivity & High Precision

    High assay precision provides confidence that any detected increases in viral load are due to clinical changes in patients, rather than assay variation.1,4

    12 copies/mL

    Limit of detection (LoD)*

    30 copies/mL

    Lower limit of quantitation (LLoQ)

    30-10 million copies/mL

    Linear range*

    Demand More from Your HIV-1 Assay1

    • Intended use: diagnosis of primary HIV-1 infection, confirmation of HIV-1 infection, HIV-1 viral load monitoring
    • Technology: Real-time Transcription-mediated Amplification (TMA)
    • Target region: pol/LTR
    • Groups: M, N, O
    • Sample Types: serum and plasma (qualitative), plasma (quantitative)
    Visual of viral infection or virus such as HIV-1

    Evidence. Insight. Collaboration.

    Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.

      *Established using the 1st WHO International Standard.

      1. Aptima HIV-1 Quant Dx Assay [package insert] AW-11853-001. Rev.010 San Diego, CA; Hologic, Inc., 2021.
      2. Hopkins M, Hau S, Tiernan C, et.al. Comparative Performance of the New Aptima HIV-1 Quant Dx Assay With Three Commercial PCR-Based HIV-1 RNA Quantitation Assays. J Clin Virol. 2015;69:56-62.
      3. Panther / Panther Fusion Operators Manual. AW-26055-001 Rev. 001 
      4. Nair SV, Kim HC, Fortunko J, et al. Aptima HIV-1 Quant Dx—a fully automated assay for both diagnosis and quantification of HIV-1. J Clin Virol. 2016;77:46-54.



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