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Aptima® HIV-1 Quant Dx Assay

Dual-claim assay to confirm HIV-1 infection and measure viral load.

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    Overview

    HIV-1 Detection and Viral Load Monitoring

    With performance you can count on, the Aptima HIV-1 Quant Dx assay is a dual-claim assay that can be used to confirm HIV-1 infection and measure viral load for optimal patient management.1 It offers reliable quantitation of HIV-1 RNA across a broad linear range, giving your lab excellent precision and sensitivity for HIV-1 detection and viral load monitoring.

    The Aptima HIV-1 Quant Dx Assay intended use is to:

    Confirm HIV Infection

    Running on the Panther® system, Aptima HIV-1 Quant Dx accurately detects and monitors HIV-1 for reliable, repeatable results.

    Monitor Viral Load

    Industry-leading precision gives you confidence that any changes in viral load reflect clinical changes in the patient—not variations in the assay.

    The Latest on Aptima Virology

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    See More Virology Highlights

    Performance You Can Count On

    Thoughtful assay design to guard against mutations.

      Sophisticated Design

      Robust assay design to guard against mutations

      The Aptima HIV-1 Quant Dx assay design provides 3 levels of protection for confidence in assay performance despite drug selection pressures and growing genetic diversity:1

      • 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 to tolerate mutations
      • Redundant oligonucleotides for consistent performance
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      High Sensitivity

      A highly sensitive assay for reliable quantitation of HIV-1 RNA.

      The Aptima HIV-1 Quant Dx Assay ensures detection and quantitation across major groups and subtypes (M, N, O)

      1) Limit of Detection (LoD): The Aptima HIV-1 Quant Dx assay can detect HIV-1 RNA as low as 12 copies/mL (3rd WHO International Standard) using a 0.5 mL sample.1

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

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      Precision

      Precise results reduce repeat testing

      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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      Claim

      Dx & Quant

      LoD

      12 copies/mL in plasma
      8.9 copies/mL in serum

      LLoQ

      30 copies/mL

      Methodology

      RT-TMA

      Verified Sample Types*

      Serum (SST, serum tubes)
      Plasma (EDTA, ACD, PPT)

      Documents

      Explore the data

      Learn More About the Aptima® Virology assays on the Panther® system.

      Package Inserts

      Your Virology IQ

      Test Your Virology Knowledge

      Take a quiz on current virology statistics and historic innovations.

      Get Started

      Question 1 of 2

      How many new cases of HIV were diagnosed in the United States in 2019?

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      ANSWER B: According to the CDC’s HIV Basic Statistics page, 36,801 people received a new HIV diagnosis in the United States and dependent areas. “An estimated 1,189,700 people in the United States had HIV at the end of 2019, the most recent year for which this information is available,” the organization reports. “Of those people, about 87% knew they had HIV.”
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      Question 2 of 2

      What significant advances in virology earned the 2004 National Medal of Technology in Medicine?

      • ×
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      ANSWER A: In 2004, the company Gen-Probe, founded in 1983 in San Diego, California, was presented with the National Medal of Technology by President George W. Bush “for the development and commercialization of new blood-testing technologies and systems for the direct detection of viral infections, including direct identification of West Nile Virus and simultaneous identification of HIV-1 and Hepatitis C virus in plasma of human blood and organ donors prior to transfusion.” Gen-Probe—and its pioneering technologies—was acquired by Hologic in 2012.
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      You’re well on your way! Continue reading about the Virology assay suite. You’ll feel more informed and empowered when speaking with your healthcare provider.

      You’re well on your way! Continue reading about the Virology assay suite. You’ll feel more informed and empowered when speaking with your healthcare provider.

      Learn More About VirologyTake Quiz Again
        References
        Disclaimer: 
        * For quantitative measurements: Tubes containing EDTA or Acid Citrate Dextrose (ACD) anticoagulants or Plasma Preparation Tubes (PPTs). For qualitative determination: Tubes containing EDTA or ACD anticoagulants, or PPTs, or Serum tubes, or Serum separator tubes (SSTs). 

        References: 
        1. Aptima HIV-1 Quant Dx Assay. US package insert AW-18107-001. Hologic, Inc,; 2020.

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