The Accula SARS-CoV-2 Test lets you deliver leading analytical sensitivity with ~1 minute of hands-on time

 

Deliver trusted test results that help protect customers and the community. Get a sample‑to‑answer solution with high sensitivity, all with less than 1 minute of hands‑on time. The Thermo Fisher Scientific™ Accula™ SARS-CoV-2 rapid PCR test* delivers among the lowest limits of detection (475 NDU/mL) and qualitative results in approximately 30 minutes.

This rapid diagnostic platform combines the accuracy of RT‑PCR with the ability to test right at the pharmacy with:

  • Gold-standard PCR technology—100% positive agreement (PPA) and negative agreement (NPA) with an EUA-authorized RT-PCR SARS‑CoV‑2 test comparator
  • Simple sample collection—prepare and load nasal swab samples quickly
  • Fast results—qualitative, rapid PCR-based test provides visual results in approximately 30 minutes
  • Compact design—dock fits in the palm of your hand; ideal fit for the retail pharmacy space
  • Easy storage—reagents stored at room temperature (15°C to 30°C, 59°F to 86°F); no calibration, easy to maintain and train on

Offer your pharmacy customers a premier COVID‑19 testing solution today.

 
 
 
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For Emergency Use Authorization (EUA) only. For prescription use only. For in vitro diagnostic use.

© 2021 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., in patient 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 MKT‑70039

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United States

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