Medsential now offering an FDA EUA Issued Antibody Rapid Test for Point of Care Providers
SALT LAKE CITY, UT / ACCESSWIRE / December 17, 2020 / U.S.-based Medsential is now offering COVID-19 IgM/IgG rapid antibody tests to point of care providers. With Covid cases reaching an all-time high, Medsential is able to supply high volumes of these antibody tests. Medsential is an FDA-registered medical device company and is operating in compliance with the FDA.
"We are thrilled to have a point of care rapid antibody test now available. We know hospitals, medical offices, and other point of care providers have been eager to make these available to their patients to provide peace of mind," said Doris Hui, CEO of Medsential. "We have several national clients who will distribute these tests on a national level; with so many Covid hotspots, this option will be greatly welcomed."
Medsential's point of care antibody test is supplied by Assure Tech. The Assure Tech antibody test has an EUA designation from the FDA for point of care administration. These COVID-19 tests provide results within 15 minutes on-the-spot and are easy to use. The test device is low-cost, so repeat testing is cost-effective. The rapid antibody test offered by Medsential does not require any other external reading device. It requires only a finger prick.
"Our rapid test kits show three levels of antibody build-up, unlike many 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."
Because of the large demand for antibody tests, Medsential has also retained their supply relationships with Newscen to distribute COVID-19 IgM/IgG testing kits. The Newscen-supplied tests are widely used internationally and have CE certification in the EU. These tests have undergone independent validation in the U.S.
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.