The Accula SARS-CoV-2 Test combines RT-PCR accuracy with a simple workflow to provide fast and convenient rapid PCR-based test results. The test’s patented PCR technology enables rapid exponential amplification while reducing overall thermocycling times, resulting in faster test results. 1
The Accula SARS-CoV-2 Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected anterior nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) anterior nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider.
Features of the Accula SARS-CoV-2 Test include:
- Rapid testing results—RT-PCR SARS-CoV-2 results in ∼30 minutes
- Streamlined process—CLIA-waived workflow
- Simplified sample collection—anterior nasal swabs and nasal mid-turbinate swabs
- Easy—store at room temperature, no need for refrigeration
The Accula SARS-CoV-2 Test is a nucleic acid amplification test (NAAT) for detection of SARS-CoV-2 viral RNA in approximately 30 minutes. To perform the test, anterior nasal or nasal mid-turbinate specimens are added to the SARS-CoV-2 buffer to solubilize the sample. An aliquot of the SARS-CoV-2 buffer is then dispensed into an Accula SARS-CoV-2 test cassette. The test cassette contains internal positive and negative controls, enzymes, OscAR™ reagents, and a detection strip necessary for the full completion of the assay. There are four steps in the process:
1. Lysis of the virus
2. Reverse transcription (RT) of viral RNA to cDNA
3. Nucleic acid amplification by PCR
In approximately 30 minutes, clinicians can quickly and reliably identify patients who are positive for COVID-19. Mutations in the following SARS-CoV-2 Variants have been demonstrated to have no impact on the performance of the Accula SARS-CoV-2 Test:2
- Alpha: B.1.1.7
- Beta: B.1.351
- Delta: B.1.617.2
- Gamma: P.1
- Omicron: B.1.1.520, B.1.1.529, BA.1, BA.1.1, BA.2, BA.2.10, BA.2.12, BA.2.12.1, BA.2.75, BA.2.75.2, BA.3, BA.4, BA.4.6, BA.5, BA.5.2.6, BF.7, BF.11, BN.1, BQ.1, BQ.1.1, XBB, and XBB.1.5
The Accula™ SARS-CoV-2 Test performed on the Accula Dock or the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chain reaction (PCR) and lateral flow technologies for the qualitative, visual detection of nucleic acid from SARS-CoV-2 in clinician-collected anterior nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) anterior nasal swab specimens, collected from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate, or waived complexity tests. The Accula SARS-CoV-2 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.
Accula SARS-CoV-2 Test results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Testing facilities within the United States and its territories are required to report all results to the appropriate public health authorities.
Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be confirmed with a different authorized or cleared molecular test in a CLIA-certified laboratory that meets the requirements to perform high or moderate complexity tests. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and/or epidemiological information.
The Accula SARS-CoV-2 Test is intended for use by trained operators who are proficient in performing tests on the Accula Dock and Silaris Dock. The Accula SARS-CoV-2 Test is only for use under the Food and Drug Administration’s Emergency Use Authorization.
The Accula SARS-CoV-2 Test Kit 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.
1 Refer to IFU
2 Test reports are available through Thermo Fisher Scientific
Please note that the most recent revision of the Instructions for use (IFU) applicable for all Accula SARS-CoV-2 Test kit is available via the link below. However, there may be some Accula SARS-CoV-2 Kit in your possession which would have the negative control swab manufactured differently. The difference in manufacturing process has no impact to the performance or safety of the negative control swab.