Confronting the Global Crisis

We are a precision medicine company
compelled to contribute to the global efforts to fight the novel coronavirus epidemic
by limiting exposure as quickly and effectively as possible.
Introducing AvellinoCoV2…

FDA Granted EUA

On March 5, 2020, Avellino completed the validation process for AvellinoCoV2 according to the FDA issued guidance ‘Policy for Diagnostics Testing in Laboratories Certified to Perform High-Complexity Testing under CLIA prior to Emergency Use Authorization for Coronavirus Disease-2019 during the Public Health Emergency’. The test must be ordered by a physician and cannot be made available directly to the public.

CLIA Validated

Avellino has validated the AvellinoCoV2 test according to CLIA Lab Developed Test (LDT) standards. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. The CDC, in partnership with CMS and FDA, supports the CLIA program and clinical laboratory quality.

What is Coronavirus Disease 2019?

Coronaviruses are a large family of viruses that are common in people and many different species of animals, including camels, cattle, cats, and bats. Rarely, animal coronaviruses can infect people and then spread between people such as with MERS-CoV, SARS-CoV, and now with this new virus (named SARS-CoV-2).

Avellino SARS-CoV-2/COVID-19 Test

A non-invasive genetic test to identify the coronavirus

The Avellino SARS-CoV-2/COVID-19 Test (AvellinoCoV2) is a non-invasive, swab based test used to detect the SARS-CoV-2 virus, a strong indicator of the patient having the COVID-19 disease. A positive result generally indicates an active infection, while a negative result should not be used as the sole basis for treatment or other patient management decisions. All results, whether positive or negative, must be combined with clinical observations, patient history, and epidemiological information for a proper medical diagnosis. AvellinoCoV2 was developed by Avellino Lab USA, Inc., in its CLIA-qualified lab and is authorized by the FDA under the Emergency Use Authorization.

How the Test Works

    1. Health care provider orders and receives the AvellinoCoV2 test kit.

    2. Health care provider collects swab samples from the patient’s nose and mouth.

    3. Health care provider ships patient’s sample to Avellino’s laboratory.

    4. Avellino conducts lab testing.

    5. Avellino prepares the patient report.

    6. Avellino sends the results to your health care provider.