Are you looking for accuracy or a rapid turnaround time for your SARS-CoV-2 testing results? There is no need to choose between these two important features in SARS-CoV-2 point of care testing. The rapid Thermo Fisher Scientific Accula SARS-CoV-2 Test uses proprietary Oscar PCR technology to shorten thermocycling times and provide a result in approximately 30 minutes.

The Limit of Detection (LoD) is among the lowest measured in the FDA SARS-CoV-2 Reference Panel. Additionally, the Accula SARS-CoV-2 Test received a Rapid Acceleration of Diagnostics contract (RADx) for rapid manufacturing scale up to meet the COVID testing demand in the United States. The test is now used routinely used in hospitals, physician office labs, urgent care centers and clinics, pharmacies, and in non-healthcare areas like schools, travel, and entertainment.

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Workflow

Accula Rapid PCR System Workflow

Here are the high-level steps of the Accula Test workflow. The test workflow begins with a sample collected by anterior or mid-turbine nasal swab and eluted in the provided sample buffer. The sample is loaded into the test cassette, and after the test runs for approximately 30 minutes, the result is visually read on the front of the test cassette.

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.

Accula Dock with Accula SARS-CoV-2 Test

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.

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.

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Resources and specifications

Accula SARS-CoV-2 Test


Format

Test Cassette Kit

Organism group

Virus

Detectable analytes

SARS-CoV-2 RNA

Sample type

Anterior nasal swab; nasal mid-turbinate swab

Technology

RT-PCR

Control sets

High/low/neg

Shelf life

Up to 18 months

Storage requirements

Room temperature

Regulatory

Certifications/ compliance

FDA Emergency Use Authorized

CLIA complexity

Waived

Accula Dock


Analysis time

~30 minutes

Throughput

~2 tests/hour per dock

Components

Accula Dock, AC power adapter, AC power cord

Electrical requirements

Dock power input: 12VDC ± 1VDC, 1A maximum

AC Power Adapter Input: 100-240VAC, 50/60Hz

AC Power Adapter Output: 12VDC, 2.08A, 25W maximum

Operating temperature

15°C to 30°C (59 to 86°F)

Dimensions (D x W x H)

14.5 x 9.9 x 9.7 cm (5.7 x 3.9 x 3.8 in)

Weight

619 g (<1.4 lb), including Dock, power adapter, and US power cord

* 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.

The Accula SARS-CoV-2 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.

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