Accula SARS-CoV-2 Test for pharmacies

Get RT-PCR laboratory accuracy at the point of care with results in ~30 minutes

 

The Thermo Fisher Scientific™ Accula™ SARS‑CoV‑2 Test has a limit of detection (LoD) that is among the lowest measured for the FDA SARS‑CoV‑2 Reference Panel1 and is available to CLIA‑waived point‑of‑care environments under the FDA Emergency Use Authorization (EUA).

 The Accula SARS-CoV-2 Test provides you with:

  • Simple nasal swab sample collection
  • Fast, qualitative results that are easy to read
  • Room temperature reagent storage
  • Up to 18-month shelf life for self-contained test cassettes
  • A palm-sized reusable dock that can run 5,000 tests

A simple hands-on process from sample collection to starting the test is expected to take approximately one minute.

Accula test workflow
 
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1. US FDA. SARS-CoV-2 Reference Panel comparative data. Content current as of 12/07/20. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/sars-cov-2-reference-panel-comparative-data.

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For Use Under Emergency Use Authorization (EUA) Only. For Prescription Use Only. For In Vitro Diagnostic Use Only.

© 2022 Thermo Fisher Scientific Inc. All rights reserved. Alltrademarks are the property of Thermo Fisher Scientific and itssubsidiaries unless otherwise specified. We hereby disclose that thisemail communication is for commercial purposes.

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The Accula SARS-CoV-2 Test has not been FDA cleared orapproved but has been authorized for emergency use by FDA for useby laboratories certified under the Clinical Laboratory ImprovementAmendments (CLIA) of 1988, 42 U.S.C. §263a, that meetrequirements to perform high, moderate, or waived complexity tests.The test is authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver,Certificate of Compliance, or Certificate of Accreditation. This testhas been authorized only for the detection of nucleic acid fromSARS-CoV-2, not for any other viruses or pathogens. Theemergency use of this test is only authorized for the duration of thedeclaration that circumstances exist justifying the authorization ofemergency use of in vitro diagnostics for detection and/or diagnosisof COVID-19 under Section 564(b)(1) of the Federal Food, Drug, andCosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration isterminated or authorization is revoked sooner.

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