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The Thermo Fisher Scientific Accula System is a rapid diagnostic point-of-care platform that enables simple sample-to-answer results with RT-PCR accuracy1,2.
The Accula System consists of the Accula Dock and Accula Test Kit. The dock is a small, reusable device about the size of your palm that holds a cassette. It plugs into a standard electrical outlet and provides power to the cassette, which contains the components and reagents for viral lysis, reverse transcription, and PCR amplification. The Accula rapid PCR tests facilitate reliable, qualitative PCR results in ~30 minutes.
Accula rapid PCR testing products
The Accula Dock consists of an electro-mechanical interface to a single test cassette with all electrical systems, controls, and logic necessary to orchestrate an in vitro diagnostic test.
The Accula Flu A/Flu B Test Kit is an RT-PCR–based test designed for use at point of care locations and combines the accuracy of PCR with the simplicity of rapid antigen tests.
The Accula SARS-CoV-2 Test Kit combines the accuracy of PCR with the simplicity of rapid antigen tests, delivering visual results in ~30 minutes.
Workflow
The Accula System workflow is elegantly simple: swab, elute, and follow the prompts on the dock to load the sample and run the test. Hands-on time is ~1 to 2 minutes, after which you can walk away. The dock notifies you to read the results when the test is complete.
What customers are saying
There's a significant edge to rapid PCR technology. It makes testing programs a lot more convenient, while imparting greater confidence.
– Dr. Vin Gupta, Critical Care Pulmonologist and Professor at the University of Washington’s Institute for Health Metrics and Evaluation
A good thing about this equipment is you can set up a testing area in a small space. It’s amazing.
– Paula Smith, Head of School, University Child Development School
The most important factor was the accuracy of the test. Number two was convenience. Having both of those made it a no brainer to incorporate Accula tests as the primary means of testing.
– James Murphy, ProAm founder and CEO
People wanted a more sensitive, more specific test to confirm their diagnosis. We felt better being able to offer a molecular option.
– Seth Beltran, Director of Point of Care Services
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References
1. Accula Flu A/Flu B Test Instructions for Use (IFU)
2. Accula SARS-CoV-2 Test Instructions for Use (IFU)
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.
The Accula SARS-CoV-2 Test is for use under Emergency Use Authorization (EUA) Only. For Prescription Use Only. For In Vitro Diagnostic Use. © 2022 Thermo Fisher Scientific Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified.
* Patient self-collection: On-site, supervised patient self-collection may be employed to reduce risk of SARS-CoV-2 transmission between patients and testing site personnel. Patients may conduct nasal swab self-collection of themselves or a child, as described in the Self Collection Quick Reference Guide. Testing site personnel must provide a physical or digital copy of the Self-Collection Quick Reference Guide to the patient prior to collection. Self-collection must occur on-site, under supervision by testing site personnel. Self-collection is limited to patients 18 years and older. Collection by an adult on a child should only be performed on children 5 years and older. Nasal swabs from children ages 0-4 years should be collected by the clinician.
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