Hologic SARS-CoV-2 Assays

Global Threat with Flexible Solutions

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.†

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. 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.

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.

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.

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.

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. With the asymptomatic distinction the Hologic Aptima and Panther Fusion SARS-CoV-2 assays offer a vital tool in identifying early infection in individuals.