Aptima® Virology

    Unparalleled diagnostic performance, fully automated

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    Aptima® Virology Assays

    The Aptima Virology portfolio delivers on the Hologic promise of innovation through life-changing viral testing for viruses that impact patients across the globe.

    Deliver Precise Results

    The excellent accuracy of Aptima assays for HIV-1, HCV and HBV give you the confidence to deliver reliable, repeatable results that you and your patients can count on.

    Experience Optimal Performance

    Aptima Virology assays operate on the Panther® system, which means ultra-fast, true sample-to-result automation—everything your lab needs to meet today’s molecular testing demands.

    Watch video to learn how HIV testing plays a key role in diagnosis, viral load monitoring and prevention.

    Download article and explore insights about the vital role of your local laboratories in HIV and HCV diagnosis and prevention.

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    Video Resources

    “...Increasing lab efficiency is mandated by changes in healthcare; necessitating an increase in throughput and automation while maintaining high assay performance.”

    Amendola A, et al.11

    Applied Innovation in Virology Testing

    Hologic and the Aptima Virology portfolio have a legacy of innovation and leadership, driving critical advances in the diagnosis and monitoring of Human Immunodeficiency Virus (HIV) and Hepatitis B and C viruses (HBV and HCV). This legacy began with the FDA approval of qualitative nucleic acid amplification tests (NAATs) for HIV-1 and HCV in the early 2000s. It continues with viral load testing for HIV-1, HCV, and HBV.

    Today, the Aptima Virology portfolio is a critical aid in the clinical management of HIV-1, HCV, and HBV. Run on the fully automated Panther system, these assays use proprietary real-time transcription mediated amplification (TMA) technology from Hologic.

    1997

    Development and Partnerships

    Development and Partnerships

    Hologic initiates development of the Procleix HIV-1/HCV assay and begins a strategic partnership with Grifols.1 Today, 75% of the United States’ donated blood supply is screened using this technology.1

    1997

    2004

    National Medal

    National Medal

    Hologic receives the National Medal of Technology and Innovation for blood-testing technologies and systems for the detection of West Nile Virus and identification of HIV-1 and HCV in human blood plasma and organ donors.2

    2004

    2006

    First FDA Approvals

    First FDA Approvals

    The Aptima HIV-1 and HCV RNA qualitative assays receive their first FDA approvals.3-6

    2006

    2016

    Aptima® HIV-1 Quant assay

    Aptima® HIV-1 Quant assay

    FDA approves the Aptima HIV-1 Quant assay for quantitation of HIV-1 RNA in plasma.3

    2016

    2017

    Aptima® HCV Quant Dx assay

    Aptima® HCV Quant Dx assay

    FDA approves the Aptima HCV Quant Dx assay for both detection and quantitation of HCV RNA in fresh and frozen serum and plasma.4

    2017

    2018

    Aptima® HBV Quant assay

    Aptima® HBV Quant assay

    FDA approves the Aptima HBV Quant assay for quantitation of HBV in plasma and serum.5

    2018

    2020

    Aptima HIV-1 Quant Dx assay

    Aptima HIV-1 Quant Dx assay

    For the first time, FDA designates a dual claim for detection and quantitation of HIV-1 with the Aptima HIV-1 Quant Dx assay.8

    2020

    2022

    Aptima® CMV Quant assay

    Aptima® CMV Quant assay

    FDA approves the Aptima® CMV Quant assay for quantitation of CMV in plasma

    2022

    The Power to Choose, The Potential to Grow.

    All virology assays are fully automated on the Panther® system, using transcription mediated amplification (TMA). TMA is widely used to amplify nucleic acids and uses specific target capture and isothermal amplification to detect nucleic acids in multiple infectious diseases, including CT, NG, HPV, Trich, and HIV/HCV/HBV for blood donor testing.* 1,2

    Choose from a broad range of STI, Women’s health, Viral load and respiratory assays on a single, fully automated platform that meets your laboratory needs, while providing a scalable and economical path to expansion for years to come.

    The Panther system has set the standard for flexibility, reliability, and performance, serving as the foundation for assay consolidation, scalability, and growth.

    As treatment options continue to evolve, Hologic offers highly sensitive virology assays on the Panther system. The Aptima Virology portfolio may be run in conjunction with the Aptima STI portfolio and Aptima HPV assays. This consolidated menu streamlines workflows, providing a solution to the challenges faced by molecular laboratories.

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    Assay Menu

    Infectious Disease

    HIV-1 Quant Dx 

    HCV Quant Dx

    HBV Quant

    CMV Quant

    Flu A/B/RSV

    Paraflu

    AdV/hMPV/RV

    SARS-CoV-2

    SARS-CoV-2/Flu/A/B

    SARS-CoV-2/Flu/A/B/RSV

    GI Bacterial

    GI Extended Bacterial

    GI Viral

    GI Parasite

    EBV

    BKV

    C. Difficile

    M. gen macrolide resistance

      Disclaimer: 
      * TMA technology is patented and owned by Hologic. In 2014, Grifols, S.A. was granted rights of commercialization of the blood and plasma screening brand, Procleix, a triplex TMA assay. In 2014, Grifols acquired certain assets from Novartis, which, among other things, included the rights to market transfusion medicine assays, Tigris and Panther instruments using TMA technology. The transaction enabled Grifols to offer screening solutions to blood and plasma donation centers. Grifols acquired Hologic’s rights to the blood screening business in 2017.
      †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 

      References: 
      1. Gill, P. and Ghaemi, A. 2008. Nucleic acid isothermal amplification technologies: a review. Nucleosides Nucleotides Nucleic Acids. 27(3):224-43. 2. Hill, C. 2001. Molecular diagnostic testing for infectious diseases using TMA technology. Expert Reve. Mol. Diagn. 1(4): 445-455. 3. Data on File. Hologic, Inc. 4. National Science & Technology Medals Foundation. Gen-Probe Incorporated: 2004 National Medal of Technology and Innovation: Medicine. Accessed April 12, 2022. 5. Aptima HIV-1 RNA Qualitative Assay. US package insert. 501623. Hologic, Inc.; 2015. 6. Aptima HCV RNA Qualitative Assay. US package insert 500237. Hologic, Inc.; 2016. 7. Aptima HIV-1 Quant Assay. US package insert AW-13242-001. Hologic, Inc.; 2016. 8. Aptima HCV Quant Dx Assay. US package insert AW-14498-001. Hologic, Inc.; 2018. 9. Aptima HBV Quant assay. US package insert AW-15644_002. Hologic Inc.; 2017. 10. Aptima HIV-1 Quant Dx Assay. US package insert AW-18107-001. Hologic, Inc.; 2021.

      Aptima® Virology

      Unparalleled diagnostic performance, fully automated

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      Information provided on this tab is intended for audiences outside the United States. Consult "USA" tab for products and claims available in the United States.

        Expand the hunt for viral targets with precise Aptima® Virology assays

        The Aptima Virology portfolio delivers on the Hologic promise of innovation through life-changing viral testing for viruses that impact patients in the United States and across the globe. Aptima Virology assays for HIV-1, HCV and HBV deliver reliable quantitation to aid in the management of these challenging viruses.

        As treatment options continue to evolve in the viral space, Hologic has answered the call for highly sensitive nucleic acid amplification tests (NAATs) with Aptima Virology assays on the fully automated Panther® system. Our Aptima Virology portfolio may be run in conjunction with the Aptima STI (sexually transmitted infections) portfolio and Aptima HPV assays. This consolidated menu streamlines workflow, providing a solution to the challenges faced by today's molecular lab.

        Applied innovation in virology testing

        The Aptima Virology portfolio has a legacy of innovation and leadership in the viral space in the United States. This legacy began with the FDA approval of qualitative NAATs for HIV-1 and HCV in the early 2000s. Menu includes viral load testing for HIV-1, HCV, and HBV. Significant distinguishing accomplishments in the virology market include:

        • 1997: Hologic developed technology to be used for the development of the Procleix HIV-1/HCV assay and began a strategic partnership with Grifols.1 Today, 75% of the United States donated blood supply is screened using this technology.1 
        • 2004: Hologic received the National Medal of Technology and Innovation for blood-testing technologies and systems for the detection of West Nile Virus and identification of HIV-1 and HCV in human blood plasma and organ donors.2 
        • 2006: Hologic gained FDA approval for the Aptima HIV-1 RNA qualitative assay and launched the Aptima HCV RNA qualitative assay.3,4 
        • 2016: FDA approval for the Aptima® HIV-1 Quant assay.5  
        • 2017: FDA approval for the Aptima® HCV Quant Dx assay.6
        • 2018: FDA approval for the Aptima® HBV Quant assay.7
        • 2020: FDA approval for the diagnostic claim to the Aptima HIV-1 Quant assay.8

        Today, the Aptima Virology portfolio is a critical set of tools that aid in the clinical management of HIV-1, HCV and HBV. Run on the fully automated Panther system, these assays use proprietary real-time transcription mediated amplification (TMA) technology from Hologic.

        The Aptima Virology portfolio: Exceptional performance meets full automation

        The Aptima viral load assays on the Panther system deliver strong assay performance, industry-leading sensitivity, broad dynamic range and flexibility in sample requirements demonstrated through substantial data and designed with users in mind.6-8

          With performance you can count on, the Aptima HIV-1 Quant Dx assay is the FIRST and ONLY dual-claim assay to confirm HIV-1 infection and measure viral load for optimal patient management.8 The Aptima HIV-1 Quant Dx assay offers reliable quantitation of HIV-1 RNA across a broad linear range.8 Now laboratorians can deliver results, so providers can deliver the best-suited treatments for patients

          Further expanding the hunt for viral load targets, the Aptima HCV Quant Dx assay features ultrasensitive performance across a wide linear range and all major HCV genotypes. This assay is indicated for use as an aid in the diagnosis of active HCV infection and as an aid in the management of HCV-infected patients undergoing HCV antiviral drug therapy.

          The Aptima HBV Quant assay is a molecular HBV treatment management assay with dual-target design. It helps providers guide treatment management for patients with chronic hepatitis B infection who are undergoing antiviral therapy. This unique design allows laboratorians to deliver results in the face of mutations.

          Proven assay performance joins Panther system automation

          The robust performance of the Aptima viral load assays, demonstrated through substantial data, provides confidence in ensuring excellence in the clinical management of patients. This proven performance, combined with the benefits of Panther system automation, promotes flexibility and operational efficiency for viral load testing success in molecular labs across the world.


          To learn more about the Aptima Virology portfolio, visit USAptimaVirology.com.

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          References: 1. Data on File. Hologic, Inc.  2. National Science & Technology Medals Foundation. Gen-Probe Incorporated: 2004 National Medal of Technology and Innovation: Medicine. https://www.nationalmedals.org/laureates/gen-probe. Accessed November 6, 2020.  3. Aptima HIV-1 RNA Qualitative Assay.  US package insert. 501623. Hologic, Inc.; 2015.  4. Aptima HCV RNA Qualitative Assay. US package insert 500237. Hologic, Inc.; 2016.  5. Aptima HIV-1 Quant Assay.  US package insert AW-13242-001. Hologic, Inc.; 2016.  6. Aptima HCV Quant Dx AssayUS package insert AW-14498-001. Hologic, Inc.; 2018.  7. Aptima HBV Quant Assay. US-IVD package insert AW-15644-001. Hologic, Inc.; 2018.  8. Aptima HIV-1 Quant Dx Assay. US package insert AW-18107-001. Hologic, Inc.; 2020.

          Package inserts