For Immediate Release
Wednesday, April 22, 2020
Medsential will begin COVID-19 rapid antibody test kits nationwide soon
SALT LAKE CITY – U.S.-based Medsential is now offering COVID-19 IgM/IgG rapid antibody tests beginning in April. These COVID-19 IgM/IgG testing kits will be available to high complexity CLIA-certified laboratories.
“In March, Medsential introduced antibody testing to federal and state leaders. We had early access to antibody test samples mid-March,” said Chiao-ih Hui, COO of Medsential. “We knew they would be a significant game-changer to coronavirus testing across the nation. Our COVID-19 test provides results within 15 minutes on-the-spot and are easy to use. The test device is low-cost so repeat testing is cost-effective. Our test does not require any other external reading device. It requires only a finger prick.”
These particular COVID-19 tests are widely used internationally and this test has CE certification in the EU. These tests are undergoing independent validation in the U.S. and Medsential has filed an EUA with the FDA. Medsential has manufacturing and distribution operations in the U.S., China and Japan and will be able to meet high-volume demand for these antibody tests.
“Our rapid test kits show three levels of antibody build-up, unlike other antibody tests that show only one,” said Hui. “This allows for more accurate identification of community spread and exposure to coronavirus.”
U.S. Sen. Orrin Hatch said, “It’s critical that countries work together to solve this pandemic. That’s why we’ve reached out to international leaders to help U.S. manufacturers and researchers in the great work they are doing to bring tests to as many Americans as possible.”
“Medsential’s testing kit will help broaden testing efforts so that we can slow the spread of coronavirus, and get our economy back on track,” said U.S. Rep. John Curtis.
The updated FDA policy specifically contemplate the use of Medsential’s type of IgM/IgG testing stating that “[The FDA] does not intend to object if companies start offering ‘serology’ tests, which can infer the presence of the new coronavirus by detecting specific blood cells produced in response to the virus.” Medsential is an FDA-registered medical device company and plans to distribute these tests in accordance with PartD of FDA's March 16 policy.