Aptima® SARS-CoV-2/Flu Assay
<!--td {border: 1px solid #cccccc;}br {mso-data-placement:same-cell;}--> Fully automated, high-throughput assay for the detection of SARS-CoV-2, influenza A (Flu A) and influenza B (Flu B) in one single assay.1
Information for Healthcare Professionals
Overview
Documents
The Performance & Flexibility you Need
Accurate and fully automated testing is critical in the fight against the threat of SARS-CoV-2. This is key to quickly identifying who’s infected and subsequently helping alleviate the spread of this virus. The assay is used for the qualitative detection and differentiation of SARS-CoV-2, influenza A virus and influenza B virus from individuals suspected of respiratory viral infection consistent with COVID-19.1
The Power to Choose & Potential to Grow
Leverage the flexibility and scalability of the Panther® System.
Efficiency
Meet any urgent need for high-throughput and fully-automated testing, delivering more than 1000 test results in 24 hours.*,2
Accuracy
Detect and differentiate SARS-CoV-2 and influenzas A and B during respiratory season to guide patient management.1
Variety
<!--td {border: 1px solid #cccccc;}br {mso-data-placement:same-cell;}--> The assays can be run alongside current infectious disease, women’s health and virology assays, enabling laboratories to unlock the free capacity on their existing Panther Systems.
Simplify & Scale the Future of Diagnostics
The Aptima SARS-CoV-2 /Flu Assay is part of the Hologic Molecular Scalable Solution, a portfolio combining a broad, high performing assay menu with high throughput automation. Designed to flexibly scale to meet your needs, from a single patient result to population level screening.
Excellent Clinical Performance
Evaluated in comparison to the Aptima SARS-CoV-2 Assay and the Panther Fusion Flu A/B/RSV assay, using a panel of remnant clinical nasopharyngeal specimens collected from patients with signs and symptoms of respiratory infection.
96.1% Positive agreement
99.6% Negative agreement
SARS-CoV-21
100% Positive agreement
99.2% Negative agreement
Influenza A1
100% Positive agreement
100% Negative agreement
Influenza B1
Challenges Faced by Laboratories During the Pandemic
The COVID-19 pandemic put unprecedented pressures on laboratories across the globe.
- Huge sample demand, underscoring the need for high-throughput molecular automation3
- Requirement to deliver rapid results to patients and clinicians3
- Uncertainty around the future for SARS-CoV-2 and other respiratory viruses4,5
Hologic was in the right place at the right time to make a profound impact on human health. Learn more about our collaboration and journey with labs during the pandemic and beyond.
Applicable Specimen Types
Nasopharyngeal swab specimens collected in UTM/VTM or Aptima Specimen Transport Medium.1
Insights
*The number of actual test results per day may vary based on individual lab practices and workflows
Aptima SARS-CoV-2/Flu Assay [package insert]. AW-26521-001. San Diego, CA: Hologic, Inc.; 2023
Panther/Panther Fusion System Operator´s Manual. AW-26055-001 Rev 001, San Diego, CA: Hologic Inc.; 2022.
Vandenberg O, Martiny D, Rochas O, van Belkum A, Kozlakidis Z. Considerations for diagnostic COVID-19 tests. Nat Rev Microbiol. 2021 Mar;19(3):171-183. doi: 10.1038/s41579-020-00461-z. Epub 2020 Oct 14. PMID: 33057203; PMCID: PMC7556561.
Messacar K, Baker RE, Park SW, Nguyen-Tran H, Cataldi JR, Grenfell B. Preparing for uncertainty: endemic paediatric viral illnesses after COVID-19 pandemic disruption. Lancet. 2022 Jul 14:S0140-6736(22)01277-6. doi: 10.1016/S0140-6736(22)01277-6. Epub ahead of print. Erratum in: Lancet. 2022 Jul 18;: PMID: 35843260; PMCID: PMC9282759.
Baker RE, Park SW, Yang W, et al. The impact of COVID-19 nonpharmaceutical interventions on the future dynamics of endemic infections. Proc Natl Acad Sci U S A. 2020 Dec 1;117(48):30547-30553. doi: 10.1073/pnas.2013182117. Epub 2020 Nov 9. PMID: 33168723; PMCID: PMC7720203.
Safety Data Sheets
Package Inserts
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