Hologic SARS-CoV-2 Assays

The emergence of SARS-CoV-2 was unforeseen, and the worldwide outbreak of COVID-19 has already impacted millions Since then, the need and recommendations for testing for SARS-CoV-2 have continuously evolved, requiring labs to be flexible with their strategies over time. Hologic’s SARS-CoV-2 portfolio and scalable automation enable labs to react to these changing needs and fully automate COVID-19 testing. With Panther® Scalable Solutions, you can run over 1000 tests in 24 hours, attaining first results in about 3 hours.1† The Panther Fusion® SARS-CoV-2 assay is a real-time PCR test and the Aptima® SARS-CoV-2 assay utilizes our proprietary TMA® technology. Both assays are intended for the qualitative detection of RNA from SARS-CoV-2 isolated and purified from nasopharyngeal, nasal, mid-turbinate and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal wash, and lower respiratory tract specimens (Panther Fusion assay only) obtained from individuals who meet COVID-19 clinical and/or epidemiological criteria.2,3 These assays are also intended for upper respiratory tract swab samples from individuals without symptoms or other reasons to suspect COVID-19 infection. The Aptima SARS-CoV-2/Flu assay utilizes our proprietary real-time TMA chemistry to detect and differentiate SARS-CoV-2, influenza A and influenza B from nasopharyngeal and nasal swabs obtained from individuals with signs and symptoms of a respiratory tract infection or who meet COVID-19 clinical and/or epidemiological criteria.4


Solutions to meet your COVID-19 testing needs.

The symptoms of COVID-19 overlap substantially with those of influenza and other respiratory viruses making it impossible to diagnose based on these symptoms alone.5
Hologic’s flexible respiratory test menu allows a single patient specimen to be tested for SARS-CoV-2 as well as other common respiratory viruses on a single, high-throughput, fully-automated platform, boosting efficiency and increasing clinical insight. Additionally, when you leverage both the power of Panther and Panther Fusion systems to run your SARS-CoV-2 assays your lab can:
  • Run more efficiently with full automation from sample-to-result, without batching.
  • Receive easy to interpret results.
  • Run multiple assays from a single specimen.
  • Have the ability to run both Aptima and Panther Fusion assays alongside each other at the same time.
With the added asymptomatic distinction, and symptomatic sample pooling, the Hologic SARS-CoV-2 assays offer a vital tool in identifying early infection in individuals as well as helping laboratories to deliver increasing numbers of molecular test results more quickly.

Power of Sensitivity

A recent report published by the FDA compared more than 50 COVID-19 molecular tests and demonstrated that the Hologic Aptima and Panther Fusion SARS-CoV-2 assays are the most analytically sensitive fully automated, high-throughput molecular tests on the market.6
Additionally, the Hologic Aptima and Panther Fusion SARS-CoV-2 assays were the first molecular diagnostic tests specifically authorized for use in both symptomatic and asymptomatic people.2,3 The U.S. Centers for Disease Control and Prevention (CDC) recently issued a guidance recommending COVID-19 tests for people who have had recent contact with infected individuals, regardless of vaccination status, a key strategy for limiting the spread of the virus.7 With the asymptomatic distinction the Hologic Aptima and Panther Fusion SARS-CoV-2 assays offer a vital tool in identifying early infection in individuals.


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Aptima® Herpes Simplex 1 & 2 assay

Globally, over 4.1 billion people are infected with HSV-1 and HSV-2 and the signs and symptoms can overlap.1 It is only through laboratory tests that these subtypes can be differentiated, which is important for managing herpes infections and identifying the risk of transmission to neonates and among sex partners.2,3