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Hologic SARS-CoV-2 Assays

PT. BIOMEDIKAL SCIENTIFIC INDONESIA | HOLOGIC DAN DIASORIN   →  Artikel   →  hologic   →  Hologic SARS-CoV-2 Assays
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Date Oktober 26, 2020
Categories hologic, Umum

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 thousands. In response to the desperate public need for rapid high-volume testing we developed SARS-CoV-2 assays on both our Panther® and Panther Fusion® systems.* Both assays will enable labs to run over 1000 tests in 24 hours and attain first results in 3.5 hours or less.†

The Panther Fusion® SARS-CoV-2 assay is a real-time PCR in vitro diagnostic test and the Aptima® SARS-CoV-2 assay is an in vitro diagnostic test utilizing 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.1,2

Test More Patients in Less Time

Now your lab can leverage both the power of Panther and Panther Fusions systems with highly sensitive tests that identify the SARS-CoV-2 virus.1,2  According to a recent report published by the FDA, the Hologic assays were the most sensitive fully-automated, high-throughput molecular SARS-CoV-2 assays available.3

Using either the Aptima or Panther Fusion assays, healthcare providers can test for SARS-CoV-2 from the same patient sample and collection vial currently used to diagnose other common respiratory viruses with overlapping COVID-19 symptoms — boosting efficiency and increasing clinical insight.

Flex Your Ability

  • Fully automated from sample-to-result, with easy to interpret results.
  • Run multiple assays from one specimen.
  • Detect and differentiate between other respiratory illnesses.
  • Run alongside other PCR and TMA assays simultaneously.

Verified Sample Collection Types1,2

For use with nasopharyngeal (NP), nasal, mid-turbinate and oropharyngeal (OP) swab specimens, nasopharyngeal wash/ aspirate or nasal wash.

  • ✓ Viral transport medium (VTM/UTM)
  • ✓ Saline
  • ✓ Liquid Amies
  • ✓ Specimen transport medium (STM)
  • ✓ Aptima® Multitest Swab Specimen Collection Kit‡

Additionally, the Panther Fusion assay has been verified for use with lower respiratory tract specimens

A Novel Virus

While there are still many unknown variables regarding SARS-CoV-2, it’s understood that the virus spreads easily from person-to-person and is believed to live in the air for several hours and on surfaces for as long as two to three days.4

What is known is that accurate tests are needed to help mitigate the spread of this global pandemic. Learn more about the Aptima and Panther Fusion SARS-CoV-2 assays and how we can help you react quickly to this emerging health threat.

* The  Aptima® and Panther Fusion® SARS-CoV-2 assays:
• These tests have not been FDA cleared or approved;
• These tests have authorized by FDA under an EUA for use by authorized laboratories;
• These tests haves been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
• These tests 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.

† Number of actual test results per day may vary based on individual lab practices and workflows.

‡ For oropharyngeal and nasal sample types.


References: 1. Panther Fusion SARS-CoV-2 assay [package insert]. AW-21159-001 Rev. 003. San Diego, CA: Hologic, Inc; 2020. 2. Aptima SARS-CoV-2 assay [package insert]. AW-21492-001 Rev.001. San Diego, CA: Hologic, Inc; 2020.  3. U.S. Food and Drug Administration. SARS-CoV-2 Reference Panel Comparative Data. Published September 15, 2020. Accessed September 21, 2020. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data 4. Doremalen N, et al. U.S. Government. Aerosol and surface stability of HCoV-19 (SARS-CoV-2) compared to SARS-CoV-1.https://www.medrxiv.org/content/10.1101/2020.03.09.20033217v1.full.pdf
Author Bimasindo