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.
The Latest On Aptima Virology
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“...Increasing lab efficiency is mandated by changes in healthcare; necessitating an increase in throughput and automation while maintaining high assay performance.”11
Amendola A, et al.
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.
The Power to Choose, the Power 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.
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.
