Fort Lauderdale’s Trividia Health, which is a global leader in blood glucose monitoring systems, is scaling up production of a test to detect the virus that causes COVID-19.
The SARS-CoV-2 Antibody Test Kit is a rapid, accurate and simple point-of-care antibody test kit that can qualitatively detect IgM and IgG antibodies against the virus that causes COVID-19, the company says. The test has been acknowledged by the FDA as part of the public health emergency.
The test provides healthcare professionals a fast, convenient way to provide patients results within 15 to 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 health care professionals for point-of-care testing and not for at-home testing.
Trividia says 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. Health care professionals will be told to 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 retailers including Walgreens, CVS, Rite Aid, Walmart, and major distributors including McKesson, Cardinal and AmerisourceBergen, as well as state and federal government agencies.
Trividia Health is the maker of the TRUE brand and is the largest U.S. manufacturer of store brand products for people with diabetes.