Type: For Accula™ PCR Tests
CLIA: (CLIA) waived - Requires Companies CLIA Number
Test Count: 1
The Accula System from Thermo Fisher Scientific the gold-standard rapid diagnostic platform that combines the accuracy of RT_PCR with the simplicity, convenience, and procedural familiarity of traditional rapid immunoassays. The Accula SARS-CoV-2 dock has received and Emergency Use Authorization(EUA) from the FDA for the detection of SARS-CoV-2 in Clinical Laboratory improvement Amendments(CLIA)- Waived environments.
Features and Benefits
Qualitative PCR results in ∼30 minutes; 10-second dock initiation/start-up; no data entry required
Gold-standard PCR technology
Used for up to 3,000 tests
Fits in the palm of your hand; ideal fit for satellite locations and clinical settings
The palm-sized Accula Dock controls reaction temperatures, timing, and fluid movements within the Accula SARS-CoV-2 Test cassette, resulting in a fast and automated SARS-CoV-2 RT-PCR assay. After approximately 30 minutes, the test results are interpreted by visualization of blue test lines on the detection strip in the test cassette. A blue process control line at the control area is used to ensure proper reagent and Accula Dock function and to confirm a valid negative test result. The simplicity of the design and display screen make for an intuitive workflow when used in conjunction with the Accula SARS-CoV-2 Test.
The Accula Dock consists of an electro-mechanical interface to a single test cassette with all electrical systems, controls, and logic necessary to orchestrate in vitro diagnostic tests within the inserted cassette. Upon insertion of a test cassette, the Accula Dock detects and identifies the cassette. After the user transfers a clinical test sample into the test cassette and closes the Accula Dock lid, embedded firmware in the dock controls fluid flow of the sample into the various chambers of the cassette, applies controlled voltage signals to the various cassette heaters (monitored by sensors within the dock), and provides visual status to the user with critical information such as estimated time to read and various error states, should they be encountered.
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 nasal or nasal mid-turbinate swab specimens or clinician-instructed self-collected (collected on site) 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 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 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.
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.