Rapid testing solutions for school health centers and more
Throughout the pandemic, colleges and universities used COVID-19 testing to limit and prevent SARS-CoV-2 transmission on campus, helping enable in-person learning and the higher education experience expected at their institutions. Campus health centers can bring COVID-19 testing in-house and offer convenience and rapid results in approximately 30 minutes.
On-campus testing benefits include:
Central and convenient testing for students, educators, or staff
Accurate and rapid PCR results in ~30 minutes
Compliance with evolving local and state regulated guidelines and protocols
Selecting the appropriate test type is important when implementing an on-campus testing solution. Reliable and accurate detection of early infection is key to preventing spread. Highly sensitive rapid RT-PCR tests can enable detection of SARS-CoV-2 days before symptoms onset [1,2] and rapid isothermal and antigen tests .
1. Arons MM, Hatfield KM, Reddy SC et al. (2020) Presymptomatic SARS-CoV-2 infections and transmission in a skilled nursing facility. N Engl J Med 382(22):2081–90. https://doi.org/10.1056/NEJMoa2008457 2. Nissen K, Hagbom M, Krambrich J et al. (2021) Presymptomatic viral shedding and infective ability of SARS-CoV-2; a case report. Heliyon 7(2):e06328. https://doi.org/10.1016/j.heliyon. 2021.e06328 3. COVID-19 Real-Time Learning Network. Rapid testing. https://www.idsociety.org/covid-19-real-time-learning-network/diagnostics/rapid-testing/. Accessed September 24, 2021
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.