SALT LAKE CITY, UT / ACCESSWIRE / April 22, 2020 / 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 laboratories and health care workers at the point-of-care under the updated guidelines issued by the FDA on March 16, 2020. Medsential is an FDA-registered medical device company and is operating in compliance with the FDA to begin distribution.
“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. Health care providers can assess the exposure of their staff and their patients to better protect vulnerable populations, including detecting COVID-19 before symptoms occur. In addition, our test can identify immunity to the virus as our bodies build up antibodies.”
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 guidelines 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.”
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Medsential LLC is a U.S. company that develops, manufactures, and distributes a broad range of medical products to customers. Established in 2005, Medsential is an ISO certified medical device company with the capabilities to develop, manufacture and assemble a broad range of products. Medsential has an extensive distribution channel, sales force, engineering platform, and production team to bring quality products to global markets. We also work with partner companies to provide clinical trial tests, distribution, manufacturing, and assembly. Medsential has manufacturing and distribution operations in the U.S., China and Japan.
Learn more: www.medsential.com
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SOURCE: Medsential LLC
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