Aptima® SARS-CoV-2 Assay

Fully-automated, high-throughput assay for the detection of SARS-CoV-2.1

Assay box in lab background

    Overview

    Documents

    Training

    The Performance & Flexibility You Need

    Accurate and fully-automated testing is critical in the fight against the threat of SARS-CoV-2. The assay is used for the qualitative detection of SARS-CoV-2 from individuals meeting COVID-19 clinical and/or epidemiological criteria, as well as individuals without symptoms or other reasons to suspect COVID-19 infection.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 SARS-CoV-2 to guide patient management.1

    Variety

    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 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.

    Technician walking through Panther systems in a lab setting

    Challenges Facing Laboratories

    The COVID-19 pandemic put unprecedented pressures on laboratories across the globe: 

    • huge sample demand, underscoring the need for high-throughput molecular automation3
    • the 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

    Applicable specimen types include:1

    • Nasopharyngeal, nasal and oropharyngeal swab specimens collected in UTM/VTM, saline, liquid Amies, eSTM or Aptima Specimen Transport Medium
    • Saliva specimens in Minimum Essential Medium
    • Pooled samples containing up to 5 individual saliva samples or upper respiratory swab specimens
    Male lab technician pushing tray of vials into medical system

    Evidence. Insight. Collaboration.

    Our education portal improves patient care through excellence in education, communication of clinical and scientific evidence, and partnerships with the healthcare community.

    Insights

    Healthcare provider looking at scan images on monitor display

    FDA Market Authorisation for Genius™ Digital Diagnostics System

    Cervical screening infographics

    Discover the Future of Cervical Cancer Screening

    A Vision for Women-centric Care

    A Vision for Women-centric Care

      *The number of actual test results per day may vary based on individual lab practices and workflows.
      1. Aptima SARS-CoV-2 Assay [package insert]. AW-22752-001 Rev. 005. San Diego, CA: Hologic, Inc.; 2023
      2. Panther/Panther Fusion System Operator´s Manual. AW-26055-001 Rev 001, San Diego, CA: Hologic Inc.; 2022
      3. 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.
      4. 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.
      5. 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.
         

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