New Screening Test for COVID-19
First sentence of seventh paragraph of release dated April 21, 2020 should read: Trividia Health will make the test kits available through major retail pharmacies and distributors, as well as state and federal government agencies. (instead of: Trividia Health will make the test kits available through major retailers including Walgreens, CVS, Rite Aid, Walmart, other leading pharmacies, and major distributors including McKesson, Cardinal and AmerisourceBergen, as well as state and federal government agencies.)
The corrected release reads:
TRIVIDIA HEALTH, INC. ANNOUNCES LAUNCH OF SARS-COV-2 ANTIBODY TEST KIT
New Screening Test for COVID-19
Trividia Health, Inc. unveiled its plans to aid in the detection of the SARS-CoV-2 virus. The first phase is a new test that has been acknowledged by the FDA under section IV.D of FDA’s Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency and is currently in the process to scale up production.
The SARS-CoV-2 Antibody Test Kit is a rapid, accurate and simple point-of-care IgG-IgM combined antibody test kit which can qualitatively detect IgM and IgG antibodies against the virus that causes COVID-19.
This test provides healthcare professionals a fast, convenient way to provide patients results within 15-20 minutes. Unlike other test methods that require a lab or proprietary analyzer, the SARS-CoV-2 test is an easy two step operation. The sample volume required is only 10 microliters of whole blood. The test is designed to provide rapid screening that is currently in high demand. These tests are needed to help identify potential patients and asymptomatic carriers to prevent secondary transmission and assure timely treatment measures.
The SARS-CoV-2 Antibody Test Kits are only to be used by clinical laboratories or healthcare professionals for point-of-care testing, and not for at-home testing. The results from antibody testing are not to be used as the only basis of diagnosis or to exclude exposure to the virus that causes COVID-19. The final diagnosis will be confirmed by a healthcare professional based on clinical symptoms and various detection indicators. As such, healthcare professionals will refer to the product labeling to review important information with regards to test results.
The second phase of Trividia’s plan is a traditional instrument based molecular diagnostic test. This test would be part of the confirmation process of the virus. The necessary data will be submitted to regulatory agencies over the next few weeks. Trividia will begin distribution upon approval.
"Trividia Health is committed to providing healthcare professionals the tools they need to quickly test patients and triage the virus on a massive scale. We hope this relieves some of the stress on our healthcare system and allows for readiness in advance of future COVID-19 virus outbreaks," said Scott Verner, President and CEO of Trividia Health. "We are proud to provide this product and deliver accurate, fast results to patients and healthcare professionals that need testing solutions at an affordable cost."
Trividia Health will make the test kits available through major retail pharmacies and distributors, as well as state and federal government agencies. Each of these partners are providing resources and assistance differently in which Trividia Health will work with them on the best way to adapt the platform to their plans.
For more information, please contact 1-800-588-0306 or COVinfo@trividiahealth.com.
About Trividia Health
Trividia Health, Inc., is a global health and wellness company based in Fort Lauderdale, Florida and a leading developer, manufacturer and marketer of advanced performance products for people with diabetes. With products sold under TRUE and store brand labels, the company is the exclusive partner and supplier of affordable, high-quality blood glucose monitoring and health and wellness solutions for the world’s leading retail pharmacies, distributors and mail service providers. For more information, please visit: www.TrividiaHealth.com.
(800) 342-7226, ext. 3150