Accula SARS-CoV-2 Test
Rapid PCR results in ~30 minutes

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Simple minimally invasive workflow

The Accula SARS-CoV-2 Test uses an anterior 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 ~30 minutes in an easy-to-interpret lateral flow readout on the cassette face (circled in red in the illustration), 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.

Reagents can be stored at room temperature (15°C to 30°C, 59°F to 86°F). Eluted samples in Accula SARS-CoV-2 buffer may be kept at room temperature (15°C to 30°C, 59°F to 86°F) for up to 2 hours or refrigerated at 2°C to 8°C and tested within 24 hours from the time of elution. Eluted samples may also be frozen for longer storage. Eluted samples in Accula SARS-CoV-2 buffer may be stored for up to 1 week at -20°C; longer storage should be at -80°C or colder².

Rapid results

The Accula SARS-CoV-2 Test is performed in a portable, palm-sized dock with a required plug-in power cord that plugs into a standard outlet, with a 10-second dock initiation/ start-up and no data entry required. Because the test can be administered, run, and interpreted in one place, time-to-results is reduce to ~30 minutes—often while the subject waits.

This is stark contrast to a standard lab-based qPCR which relies on specialized materials and instruments, highly trained personnel, and transportation of specimens to a centralized laboratory. Samples are batched (many are run at the same time on a highthroughput instrument), and time-to-results can vary from several hours to several days.

The rapid results of PCR virus detection are achieved by using our proprietary Oscillating Amplification Reaction (Oscar) PCR technology that enables shortened thermocycling times and faster PCR completion without the need for costly thermal cycler hardware and optical detection systems used in laboratory-based qPCR.

This makes the Accula SARS-CoV-2 Test a practical tool for screening symptomatic patients or patients suspected of COVID19 by healthcare professional.

Self-contained test

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. These steps all take place inside the closed cassette under controlled, varying temperatures for optimal results.

When complete, results are visualized on the cassette face as a blue line and/or control line, similar to a home pregnancy test. Each cassette performs a single patient test and is then discarded as biowaste per local, state, and Federal regulations.

Analytical sensitivity

The lower the limit of detection, the smaller the amount of viral RNA the test 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 comparable to the leading lab-based RT-PCR test and is far more sensitive than all other rapid PCR or rapid isothermal tests.

Accuracy

Test accuracy is measured by percentage agreement with a reference method. In a prospective clinical validation study², the Accula SARS-CoV-2 Test achieved 100% positive and negative percent agreement (PPA and NPA) with an EUA-authorized RT-PCR SARS-CoV-2 test. In a retrospective specimen study² the Accula SARS-CoV-2 Test achieved 95.8% positive and 98% negative percent agreement.

FDA Reference Panel results for widely utilized lab-based and rapid NAATs².

Authorized for CLIA-waived environments

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations like ambulances, hospital rooms, physicians' offices, pharmacies, etc³.

The Accula SARS-CoV-2 Test is used in health care settings to isolate or defer treatments for patients who are in labor, require preoperative assessment, or who receive chemotherapy. In non-healthcare settings, temporary clinical laboratories have been set up close to where testing is required, such as gymnasiums, workplaces, parking lots, and even trailers. The test is excellent for screening individuals going to work or school, or participating in activities involving close human contact such as sports. It can be used in other mobile settings that need to perform frequent, accurate, rapid SARS-CoV-2 testing.

Currently, the Accula SARS-CoV-2 Test is emergency use authorized for use only in the United States.