The American Academy of Pediatrics and the Centers for Disease Control and Prevention recommend testing for infections with SARS-CoV-2, the virus that causes COVID-19, to inform individual patient care and decision-making for parents and families.
Children, especially those school-aged, may be in close contact with their peers, which increases the likelihood of exposure and spread in their households. Pediatric healthcare providers should be prepared to test them and make recommendations based on their circumstances.
The Thermo Fisher Scientific Accula SARS-CoV-2 Test can be used with patients of any age. The simple testing workflow uses a minimally invasive anterior nasal swab, and the entire testing process requires as little as two minutes of hands-on time. Anterior nasal swabs from children ages 0–4 should be collected by the clinician, whereas children 5 years and older can be collected by an adult*.
This test utilizes a small reusable palm-sized dock that can plug into any standard electrical outlet and can be run at the point of care. The single-use test cassette is self-contained and compact. Finally, the test can be used in any CLIA‑waived environment.
The Accula SARS-CoV-2 Test uses proprietary Oscar™ PCR technology to shorten thermocycling times and provide a result in about 30 minutes. The Limit of Detection (LoD) is among the lowest measured for the FDA SARS-CoV-2 Reference Panel**.
*Should follow instructions on collection by a clinician.
**Data source: US FDA. SARS-CoV-2 Reference Panel comparative data. Content current as of 12/07/20.
The Accula SARS-CoV-2 Test has not been FDA cleared or approved but has been authorized for emergency use by 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.