What is Coronavirus Disease 2019 (COVID-19)?
Coronaviruses are a large family of viruses common in people and in various animal species. In rare cases, animal coronaviruses can infect humans and then spread between people, as seen with MERS-CoV, SARS-CoV, and the novel SARS-CoV-2 associated with COVID-19.
For current public health guidance, see the CDC’s COVID-19 resource.
FDA EUA Granted & CLIA Validated
FDA Emergency Use Authorization
Avellino completed validation for AvellinoCoV2 according to FDA guidance for high-complexity laboratories operating under CLIA. The test is available by physician order and is not sold directly to the public.
CLIA Validation
AvellinoCoV2 was validated to CLIA Lab Developed Test (LDT) standards. CLIA establishes federal quality standards for all U.S. facilities that test human specimens for health assessment or diagnosis, with oversight by CMS, FDA, and CDC.
Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2)
What the test does
The AvellinoCoV2 test is a non-invasive, swab-based RT-PCR assay used to detect the presence of the SARS-CoV-2 virus. A positive result generally indicates an active infection.
Negative results should not be the sole basis for treatment or other patient management decisions. Results must be considered with clinical observations, patient history, and epidemiological information.
How the Test Works
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1. Healthcare provider orders and receives the AvellinoCoV2 test kit. |
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2. Provider collects swab samples from the patient’s nose and mouth. |
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3. Sample is shipped to Avellino’s CLIA-qualified laboratory. |
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4. Avellino performs RT-PCR testing in the lab. |
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5. Avellino prepares the patient report. |
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6. Results are sent to the ordering healthcare provider. |
Frequently Asked Questions
Who can order the AvellinoCoV2 test?
The test must be ordered by a licensed healthcare provider and is not offered directly to the public.
How quickly are results available?
Turnaround times may vary by volume and logistics. Your provider will advise expected timelines based on current lab capacity.
What do positive and negative results mean?
A positive result generally indicates active infection. A negative result should not be the sole basis for clinical decisions and should be evaluated with symptoms, exposure history, and epidemiological factors.
Where can I find public health guidance?
Refer to the CDC COVID-19 page for the latest guidance.