Accula SARS-CoV-2 Test for pharmacies

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

 

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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 anterior nasal swab 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
 
Article
 
Article

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. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. We hereby disclose that this email communication is for commercial purposes.

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The Accula SARS-CoV-2 Test has not been FDA cleared or approved but has been authorized for emergency use by FDA for use by laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C. §263a, that meet requirements 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 test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

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United States

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