Offer accurate, official RT-PCR COVID-19 results in ~30 minutes at your pharmacy
With the Accula SARS-CoV-2 Test, you can offer an easy to administer, minimally-invasive test right in your pharmacy that utilizes the same gold standard, reverse transcription polymerase chain reaction (RT-PCR) technology as laboratory based tests, but provides visual results in approximately 30 minutes. Administered and interpreted at the point of care, the test requires approximately 1 minute of hands-on time, while achieving equivalent accuracy and sensitivity as a laboratory-based test.
Fully integrated on a single-use cassette and a reusable, palm-sized dock, and authorized under an FDA EUA in settings operating minimally under a CLIA Certificate of Waiver. The Accula SARS-CoV-2 Test has received emergency use authorization (EUA) from the FDA and 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. The Accula SARS-CoV-2 Test has been successfully deployed in airports, pharmacies, workplaces, educational institutions, and sporting organizations. Now you can deliver trusted test results that help protect patients and the community, while supporting business growth and providing a convenient, cost-effective testing solution.
The Accula SARS-CoV-2 Test combines the accuracy of gold-standard PCR with the speed and simplicity of antigen tests, delivering visual results in approximately 30 minutes. The system enables rapid, accurate, PCR testing with these features:
Gold-standard technology for accuracy and sensitivity
The test’s sensitivity, measured by the smallest amount of viral RNA it can detect, is 475 NDU, comparable to or better than standard lab-based PCR tests according to FDA data.[i]
Self-contained and compact
Fully integrated single-use cassette and reusable, palm sized dock.
The test requires approximately 1 minute of hands-on time. Results are visually interpreted on the cassette by the presence of a blue line, similar to a home pregnancy test. Refer to the section below for details.
OSCillating Amplification Reaction (Oscar™), proprietary PCR technology, enables rapid exponential amplification while reducing overall thermal cycling times. Your customers can shop while they wait for their on-site, same- day results.
Authorized for CLIA-waived environments
The test is available under an FDA Emergency Use Authorization (EUA) in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
The Accula System workflow is elegantly simple: just swab, elute, and follow the prompts on the dock to load the sample and run the test. Hands-on time is about 1 minute, after which you can walk away and let the test run. The Accula Dock provides you with an audible notification and screen prompt indicating results are ready when the test is complete.
The Accula SARS-CoV-2 Test uses a minimally-invasive nasal swab or nasal mid-turbinate swab sample. The test allows for self-collection and elution of a nasal swab sample, minimizing the potential for transmission between subject and tester.
Results appear in approximately 30 minutes in an easy-to-interpret lateral flow readout on the cassette face, much like a home pregnancy test. Any shade of blue at the T (test) position is interpreted as a positive result. Lacking blue at the T position, any shade of blue at the C (positive control) position is interpreted as a negative result. Finally, any shade of blue at the NC (negative control) position, or no blue anywhere, represents an inconclusive or invalid result and should be repeated.
Test materials can be stored at room temperature (15°C–30°C, 59°F–86°F). Eluted samples in Accula buffer may be kept at room temperature for up to 2 hours, or refrigerated at 2°C–8°C (35.6°F–46.4°F) and tested within 24 hours from the time of elution. Eluted samples may also be frozen for longer storage.
Insurance may not be accepted for voluntary testing purposes, so customers who request to be tested prior to travel or for other personal reasons may need to pay out of pocket. However, patients who are symptomatic or have been exposed to a COVID-19 patient may qualify for no-cost testing through their insurance.
The nasal swab is simple, quick, painless, and minimally invasive compared to the more invasive nasopharyngeal swab.
RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) is a method used to determine the presence of SARS-CoV-2 viral RNA in a sample. It is the most sensitive and accurate method of detecting a virus and is usually performed in a lab. The Accula SARS-CoV-2 Test is a rapid RT-PCR test that duplicates the same process and achieves the same level of accuracy in approximately 30 minutes at the point of care.
Nucleic Acid Amplification Tests (NAAT) are molecular tests that look at DNA or RNA. There are two different types of NAAT tests available: isothermal and RT-PCR. Typically, PCR based tests are more accurate than isothermal tests. For more information, visit https://www.cdc.gov/coronavirus/2019-ncov/lab/naats.html
Whereas antigen tests detect viral proteins in a sample, PCR detects viral RNA which is a more direct and sensitive method of detection leading to higher accuracy of your test. Most COVID-19 travel requires a RT-PCR test because of its superior accuracy when compared to antigen tests.
Test sensitivity is measured by limit of detection (LoD) using a reference panel. The lower the limit of detection, the smaller the amount of viral RNA the assay can detect. The FDA established a Reference Panel for SARS-CoV-2 nucleic acid amplification tests (NAATs), enabling direct comparison of LoD) across Emergency Use Authorization (EUA) tests, utilizing standardized material and a common protocol. Data reported by the FDA on a variety of NAATs showed that the LoD of the Accula SARS-CoV-2 Test is 475 NAAT/detectable units (NDUs), comparable to the best lab-based RT-PCR test and far more sensitive than all other rapid methods tested. For data, see our website.
The reusable dock is about the size of the palm of your hand and plugs into a standard AC power outlet. It holds one test cassette and can run one test at a time, which occupies it for approximately 30 minutes, after which it can be used immediately to run another test. For higher throughput testing needs, multiple Accula Docks can be purchased and run on-site independently.
Check with your distributor or GPO to find out if they carry the Accula SARS-CoV-2 Test. The Accula SARS-CoV-2 Test is already available through McKesson, Cardinal, Henry Schein, and Medline.
You can also order directly from Thermo Fisher Scientific by requesting a quote.
This test has not been FDA cleared or approved but has been authorized for emergency use by the 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.
For Emergency Use Authorization (EUA) Only. For prescription use only. For in vitro diagnostic use.