Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay
Save time and resources with four results in one test, on a fully automated system.
Overview
Documents
Training
Your Solution for Respiratory Testing
Seasonal respiratory testing surges can be unpredictable. Accurate diagnosis of respiratory infections improves patient care, ensuring that patients receive timely and appropriate antiviral treatment for influenza and COVID-19.1 Choose a scalable, automated platform to detect and differentiate four of the most common seasonal respiratory viruses in one test: SARS-CoV-2, influenza A, influenza B and RSV.2 Distinguish overlapping signs and symptoms on a platform that can seamlessly adjust to increased volume demands.
Manage Sample Surges
Multiplexed respiratory testing can lessen burden on the lab, saving both time and resources.3 Prepare for unpredictable respiratory surges with full sample-to-result automation and ready-to-use reagent cartridges.
Accurately Identify Illness
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay uses PCR technology to detect and differentiate COVID-19, Flu A, Flu B and RSV. Multiplex respiratory testing is encouraged by the CDC, offering diagnosis of overlapping signs and symptoms.3
Improve Patient Management
Assay design provides comprehensive strain coverage and the ability to mask any result; positive results include Ct values.2 Using a single patient sample, run any combination of Hologic’s respiratory assays for expanded targets.
Multi-center clinical study of FDA-cleared Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay4
four target assay demonstrated robust clinical performance
comprehensive solution providing mid- to high-throughput, multiplex respiratory testing
One Sample, Multiple Insights
Our complete menu of multiplexed assays allows your lab to personalize patient testing. Process a single sample on the Panther Fusion® system with any combination of assays to distinguish overlapping signs and symptoms of common respiratory viruses. Customize seasonal respiratory testing, year-round, on a fully automated platform.
Aptima® SARS-CoV-2 Assay*
Aptima® SARS-CoV-2/Flu A/B Assay*
Panther Fusion® Flu A/B/RSV Assay
Panther Fusion® AdV/hMPV/RV Assay
Panther Fusion® Paraflu Assay
Panther Fusion® SARS-CoV-2 Assay*
Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay
Sample Type
Nasopharyngeal swab
Nasal swab in development†
Collection Devices
Universal Transport Media (UTM)
Viral Transport Media (VTM)
Enhanced Specimen Transport Media (eSTM)
Throughput
Run 1 to 1,000 tests in 24 hours
RespDirect™ Collection Kit (eSTM)
Directly load samples on the Panther Fusion system for safer handling and faster results. Eliminate uncapping and specimen transfer steps with our enhanced direct load tube with penetrable cap.
Read the Latest on Panther Fusion Respiratory Assays
Multi-center clinical evaluation of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasopharyngeal swab specimens from symptomatic individuals.
Performance Evaluation of RespDirectTM Specimen Collection Kit in the Panther Fusion® SARS-CoV-2/Flu A/B/RSV Assay.
The Panther Fusion® System:
An All-In-One Solution
- Manage high- and low-volume throughput on one system. Scale up testing when needed – utilizing the available capacity on your Panther Fusion® system.
- Increase output per shift. Process up to 1000 Panther Fusion® samples in 24 hours, without increasing staff.5
- Set it and forget it. Increase your walk-away time and increase efficiency with random and continuous access, and bi-directional LIS, on a fully automated system.
- Simplify processing and minimize waste. Reduce hands-on time with ready-to-use Panther Fusion® reagent cartridges. Each Cartridge can run 12 tests and has 60-day onboard stability.2
Ordering Information
* The Aptima SARS-CoV-2, Panther Fusion SARS-CoV-2 and Aptima SARS-CoV-2/Flu 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 SARS-CoV-2/Flu assay has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, Flu A virus, Flu 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.
† Nasal claim is in development
References: 1. CDC. Similarities and Differences between Flu and COVID-19. https://www.cdc.gov/flu/symptoms/flu-vs-covid19.htm 2. Panther Fusion SARS-CoV-2/Flu A/B/RSV [package insert]. AW-27555. San Diego, CA; Hologic, Inc. 2023. 3. CDC. 07/21/2021: Lab Alert: Changes to CDC RT-PCR for SARS-CoV-2 Testing. 4. Sasidharan A and Selvarangan R. Multi-center clinical evaluation of the Panther Fusion SARS-CoV-2/Flu A/B/RSV assay in nasopharyngeal swab specimens from symptomatic individuals. J Clin Microbiology JCM. 00827-23; DOI: 10.1128/jcm.00827-23 5. Data on File.https://www.cdc.gov/locs/2021/07-21-2021-lab-alert-Changes_CDC_RT-PCR_SARS-CoV-2_Testing_1.html.
Safety Data Sheets
Package Inserts
Overview
Package Inserts
Resources
Syndromic Respiratory Testing.
Patient-Specific Results.
The Panther Fusion Respiratory assays are the premier set of assays on the Panther Fusion® system. You can provide truly personalized syndromic respiratory testing with qualitative detection and differentiation of the most common respiratory viruses from a single patient sample. Each Panther Fusion Respiratory assay can be processed independently or simultaneously with other Panther Fusion® and Aptima® assays.
The Panther Fusion® SARS-CoV-2/Flu A/B/RSV, Panther Fusion® Flu A/B/RSV, Panther Fusion® Paraflu, Panther Fusion® AdV/hMPV/RV and Panther Fusion® Bordetella assays comprise the CE-IVD respiratory testing menu on the fully automated Panther Fusion system. Each is a multiplex, real-time PCR in vitro diagnostic test. These assays can be run on nasopharyngeal (NP) swab specimens obtained from individuals exhibiting signs and symptoms of a respiratory tract infection.1-5 Additionally, the Panther Fusion® SARS-CoV-2 assay has received Emergency Use Authorization for the detection of SARS-CoV-2 from nasopharyngeal, nasal, mid-turbinate and oropharyngeal swab specimens, nasopharyngeal wash/aspirate or nasal wash, and lower respiratory tract specimens.6
Personalized Respiratory Testing
The Panther Fusion assays provide the flexibility to run patient-specific targets, allowing for personalized patient testing and better cost control in your lab.
- The Panther Fusion® SARS-CoV-2/Flu A/B/RSV assay§ - Qualitative detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus and respiratory syncytial virus.1
- The Panther Fusion® Flu A/B/RSV assay - Qualitative detection and differentiation of influenza A virus, influenza B virus and respiratory syncytial virus.2
- The Panther Fusion® AdV/hMPV/RV assay - Qualitative detection and differentiation of adenovirus, human metapneumovirus and rhinovirus.3
- The Panther Fusion® Paraflu assay - Qualitative detection and differentiation of parainfluenza 1 virus, parainfluenza 2 virus, parainfluenza 3 virus and parainfluenza 4 virus.4
- The Panther Fusion® Bordetella assay† - Qualitative detection and differentiation of Bordetella pertussis and Bordetella parapertussis.5
- The Hologic® SARS-CoV-2 assays*‡ - Qualitative detection of SARS-CoV-2 virus.6-8
Flex Your Ability
With the Panther Fusion Respiratory assays, a single patient specimen can be tested for SARS-CoV-2 as well as other common respiratory viruses which present with overlapping symptoms, boosting efficiency and increasing clinical insight.
Additionally, when you leverage the power of Panther Fusion, your lab can:
- Run more efficiently with full automation from sample-to-result.
- Receive easy-to-interpret results.
- Personalize syndromic respiratory testing by processing multiple assays from a single specimen.
- Control costs by running only the required assays and reduce expense of unnecessary tests.
- Eliminate the need for reagent preparation with Panther Fusion’s ready-to-use format.
- Reduce waste with 60 day on-board reagent stability.
- Consolidate menu onto a single, fully automated platform with the ability to run both Aptima and Panther Fusion assays alongside each other at the same time.
Resources
Education
* The Aptima SARS-CoV-2, Panther Fusion SARS-CoV-2 and Aptima SARS-CoV-2/Flu 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 SARS-CoV-2/Flu assay has been authorized only for the simultaneous qualitative detection and differentiation of nucleic acid from SARS-CoV-2, Flu A virus, Flu 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 Panther Fusion Bordetella Assay is TGA approved and CE marked, it is not Health Canada approved.
‡The Panther Fusion SARS-CoV-2 Assay is Health Canada and TGA approved, it is not CE marked.
§The Panther Fusion SARS-CoV-2/Flu A/B/RSV Assay is CE marked, it is not Health Canada or TGA approved. In development and not for sale in the U.S.
References: 1. Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. Package insert AW-25328. Hologic, Inc.; 2022. 2. Panther Fusion A/B/RSV assay. Package insert AW-16162 Hologic, Inc.; 2018. 3. Panther Fusion AdV/hMPV/RV assay. Package insert AW-16164. Hologic, Inc.; 2019. 4. Panther Fusion Paraflu assay. Package insert AW-16163. Hologic, Inc.; 2018. 5. Panther Fusion Bordetella assay. Package insert AW-18637. Hologic, Inc.; 2018. 6. Panther Fusion SARS-CoV-2 assay. Package insert AW-21388. Hologic, Inc.; 2021. 7. Aptima SARS-CoV-2 assay. US package insert AW-21492-001. Hologic, Inc.; 2021. 8. Panther Fusion SARS-CoV-2/Flu assay. US package insert AW-22364. Hologic, Inc; 2021.
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