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This Fact Sheet informs you of the significant known and potential risks and benefits of the emergency use of a Molecular Laboratory Developed Test (LDT) COVID-19 Authorized Test ( Molecular LDT COVID-19 Authorized Test) that has been issued an Emergency Use Authorization (EUA) by FDA. The Molecular LDT COVID-19 Authorized Test is authorized for use on respiratory specimens collected from individuals suspected of COVID-19 by their healthcare provider.
Mean incubation time is estimated to be ~5 days after exposure (range 4.1 - 7.0 days, but as short as 36 hours or as long as 14 days). Transmission can occur from an infected person who is asymptomatic (prior to onset of symptoms), although transmission is likely more efficient once symptoms develop.
Aegis personnel are not able to collect specimens for SARS-CoV -2 diagnostic testing. At this time, the CDC recommends that specimens be collected either by a healthcare professional or under the supervision of a healthcare professional.
Aegis currently utilizes a molecular real-time RT-PCR assay manufactured by Thermo Fisher Scientific, Inc. known as the TaqPath COVID-19 Combo Kit, which is used in accordance with the manufacturer's EUA authorization. Aegis' in-house verification of the performance of the aforementioned assay demonstrated.
Supervisory guidelines may be altered, including for resident trainees. Telehealth opportunities are also increased. Physicians and extenders should consult their local state boards to ensure that any COVID-19-related practice initiatives align with state law and the provider's scope of practice.
Precise, Flexible Molecular Diagnostic Testing for Rapid, Accurate Diagnoses of Infectious Diseases
Aegis offers a suite of the most common pathogens customized for precision diagnostics.
Speed up the time to finding and eliminating the problem for your patients. Our Infectious Disease testing was specially designed to offer: