Offer efficient & accurate COVID-19 testing at your urgent care with results in ~30 minutes
With the rapid Accula SARS-CoV-2 Test, you get a small, point-of-care diagnostic platform that delivers PCR-accurate results you can trust for all patients in approximately 30 minutes. The workflow is simple and requires just one minute of hands-on time with no data entry or instrument self-test. It’s that simple.
Patients expect fast, quality care. Deliver a higher quality of care with a diagnostic test that is not only simple to run but consistently enables accurate, reliable results.
The Accula SARS-CoV-2 Test combines the accuracy of RT-PCR laboratory tests with the speed and simplicity of antigen tests, delivering visual results in approximately 30 minutes at the point of care. The system enables rapid, accurate, PCR testing with these features:
The test is minimally invasive and requires about 1 minute of hands-on time: collect and load the sample and walk away. Results are visualized on the cassette face as one or more blue lines, similar to a home pregnancy test. See the next section for details.
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.1
Proprietary technology shortens PCR cycling times, providing results in approximately 30 minutes.
Self-contained and compact
Fully integrated single-use cassette and reusable, palm-sized dock.
Authorized for CLIA-waived environments
The test is available under an FDA Emergency Use Authorization (EUA) in settings operating under a CLIA Certificate of Waiver, and is appropriate for near-patient testing at the point of care.
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 about 1 minute, after which you can walk away.
The dock notifies you to read the results when the test is complete. Results appear in approximately 30 minutes in an easy-to-interpret lateral flow readout on the cassette face, much like a home pregnancy test. With PCR accuracy and lateral flow simplicity, the Accula System offers unrivaled efficiency in point-of-care diagnostic testing.
Urgent care providers looking to deliver PCR accuracy to their patients often send their samples out to centralized laboratories that run hundreds of samples each day on highly complex RT-PCR instruments. While this method delivers highly accurate results, the time to result can be a day or more. For many patients, this inconvenience and delay may lead them to seek a faster solution.
The Accula System delivers highly accurate PCR results in approximately 30 minutes using our proprietary PCR technology that enables shortened thermocycling times and faster PCR completion. This technology allows for the accuracy of laboratory-based PCR, right at the point of care. Because the test can be administered, run, and interpreted in your urgent care center, time-to-results is reduced to approximately 30 minutes. With an unparalleled combination of speed, simplicity and PCR accuracy, the Accula System is well suited for the urgent care environment to help deliver results you can trust with the convenience your patients expect.
RT-PCR (Reverse Transcriptase Polymerase Chain Reaction) is a method of detecting nucleic acid in order 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. Many COVID-19 screening applications, such as travel, require a RT-PCR test because of its greater accuracy over 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 nasal swab is simple, quick, painless, and minimally invasive compared to the more invasive nasopharyngeal swab.
The reusable dock is about the size of your palm 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. To run multiple tests simultaneously, just add additional docks.
You’ll need a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver to administer the Accula SARS-CoV-2 Test under the FDA’s Emergency Use Authorization. Learn more at this CDC page.
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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 Shein, and Medline.
You can also order directly from Thermo Fisher Scientific:
Check back for information about other rapid tests on the Accula platform. The Accula SARS-CoV-2, Flu A/B Combo Rapid PCR Test is currently in development and coming soon. Assays for Influenza A/ B, Respiratory Syncytial Virus (RSV), and Strep A have already received Section 510(k) clearance and CLIA waiver from the FDA.
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.
1US FDA. SARS-CoV-2 Reference Panel comparative data. Content current as of 12/07/20. Full text