Aptima® Virology

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 1990s. Recent menu additions include viral load testing for HIV-1 and HCV, with an HBV assay coming soon. 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

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.5-7 

A new standard in viral load monitoring 

  • With performance you can count on, the Aptima HIV-1 Quant assay offers reliable quantitation of HIV-1 RNA across a broad linear range.5 Now laboratorians can deliver results, so providers can deliver the best-suited treatments for patients. The Aptima HIV-1 Quant assay is used in conjunction with clinical presentation and other laboratory markers for disease prognosis and as an aid in monitoring the effects of antiretroviral treatment.5  

Sensitivity across a wide linear range and all major genotypes 

  • 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.6 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.6

Dual-target HBV Monitoring

  • The Aptima HBV Quant assay is a molecular HBV treatment management assay with dual-target design.7 It helps providers guide treatment management for patients with chronic hepatitis B infection who are undergoing antiviral therapy.7 This unique design allows laboratorians to deliver results in the face of mutations.7

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, promote 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.

 


References: 1. Hologic, Inc. Data on File.  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 29, 2017.  3. Aptima HIV-1 RNA Qualitative Assay [package insert]. 501623, Rev. 002. San Diego, CA: Hologic, Inc.; 2015.  4. Aptima HCV RNA Qualitative Assay [package insert]. 500237, Rev. 003. San Diego, CA: Hologic, Inc.; 2016.  5. Aptima HIV-1 Quant Assay [package insert]. AW-13242, Rev. 001. San Diego, CA: Hologic, Inc.; 2017.  6. Aptima HCV Quant Dx Assay [US-IVD package insert]. AW-14498-001, Rev. 001. San Diego, CA: Hologic, Inc.; 2017.  7. Aptima HBV Quant Assay [US-IVD package insert]. AW-15644, Rev. 001. San Diego, CA: Hologic, Inc.; 2018.

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 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 and globally. This legacy began with the release of qualitative NAATs for HIV-1 and HCV in the 1990s. Recent menu additions include viral load testing for HIV-1, HCV and HBV. Significant distinguishing accomplishments in the global 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: The National Medal of Technology and Innovation (USA) awarded 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 
  • 2014: Entry into the viral load space with CE-Marked Aptima HIV-1 Quant Dx assay.5 
  • 2015: CE-Marked Aptima HCV Quant Dx and Aptima HBV Quant assays released.6,7 
     

Today, the Aptima Virology portfolio is a critical set of tools that aid in the clinical management of HIV-1, HCV and HBV.

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.5-7 

Excellent sensitivity meets excellent precision5 

  • One assay with multiple uses, the Aptima HIV-1 Quant Dx assay is used as an aid in the diagnosis of HIV-1 infection, and as a confirmation of HIV-1 infection, in conjunction with clinical presentation and other laboratory markers for disease prognosis in HIV-1 infected individuals. It is also used as an aid in the clinical management of antiretroviral treatment. The assay has excellent performance, so laboratorians can measure changes in the concentration of HIV-1 RNA with confidence. This assay uses NAAT precision for viral load testing. 

Sensitivity across a wide linear range and all major genotypes6 

  • 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 the confirmation of active infection after a positive antibody test and to monitor patients undergoing HCV antiviral drug therapy. 

The dual-target HBV monitoring assay7 

  • 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 HBV infection 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, promote flexibility and operational efficiency for viral load testing success in molecular labs across the world.

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


References: 1. Hologic, Inc. Data on File.  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 29, 2017.  3. Aptima HIV-1 RNA Qualitative Assay [package insert]. 501623, Rev. 002. San Diego, CA: Hologic, Inc.; 2015.  4. Aptima HCV RNA Qualitative Assay [package insert]. 500237, Rev. 003. San Diego, CA: Hologic, Inc.; 2016.  5. Aptima HIV-1 Quant Dx Assay [CE-IVD package insert]. AW-11853-001, Rev. 004. San Diego, CA: Hologic, Inc.; 2017.  6. Aptima HCV Quant Dx Assay [CE-IVD package insert]. AW-13249-001, Rev. 002. San Diego, CA: Hologic, Inc.; 2017.  7. Aptima HBV Quant Assay [CE-IVD package insert]. AW-13182-001, Rev. 003. San Diego, CA: Hologic, Inc.; 2017. 
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