Able Diagnostics, Inc.1 (858) 309-8565
12396 World Trade Drive, Suite 216, San Diego, CA 92128, USA
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SAN DIEGO, CA. (March 19, 2020) — Able Diagnostics, a biotech company based in San Diego, CA., announced that on March 19, 2020 it will start to prepare and distribute VivaDiag COVID-19 IgM/IgG Rapid Test after receiving a confirmation of notification from the U.S. Food and Drug Administration (FDA). The test can be used by clinical laboratories and healthcare professionals for Point of Care Testing (POCT) for the rapid, qualitative detection of IgM and IgG antibodies to COVID-19 in human whole blood (fingertip), serum or plasma.
The test utilizes colloidal gold technology and is designed to provide quick and easy test results within 15 minutes using a 10 μL specimen. On March 19, 2020, Lee Mariano, founder, President and Chief Executive Officer of Able Diagnostics Inc. said, "At Able Diagnostics, we truly care about our patients and we want to do our part to help. We believe healthcare professionals need a quicker and more simplified test to help detect people who might be infected in the fight against the spread of Coronavirus. Our tests will fulfill that need exactly."
VivaDiag COVID-19 IgM/IgG Rapid Test is developed and produced by the manufacturer, VivaChek Biotech (Hangzhou) Co. Ltd, and will be distributed exclusively by Able Diagnostics in the US to ensure proper distribution and good business practices during this public health emergency. "We will rely on our current trusted distribution partners first, meanwhile, we will welcome and evaluate new distribution partners as well", said by Lee Mariano.
VivaDiag COVID-19 IgM/IgG Rapid Test provides qualitative detection of IgM and IgG antibodies for current and past infections, respectively. It allows healthcare professionals to test patients who show symptoms, as well as those who do not. It is intended to be used in conjunction with molecular diagnostic testing method. This test has not been reviewed by the FDA, however, a confirmation of notification from the FDA allows distribution to begin. Results from antibody testing should not be used as the sole basis to diagnose or exclude COVID-19 infection.
For more information visit https://ablediagnostics.com/prods/vivaguard-covid19.html
About Able Diagnostics, Inc.: Able Diagnostics Inc. is the US arm of VivaChek Biotech (Hangzhou) Co. Ltd, and was founded by a highly passionate group of experienced diagnostic product professionals who want to make a difference. Together, our goal is to grow as a trustworthy POCT solution provider and deliver high quality and reliable products that exceed customers’ expectations. For more information please visit https://www.ablediagnostics.com.