We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies. Cookie Policy.

Features Partner Sites Information LinkXpress
Sign In
Advertise with Us
Abbott Diagnostics

Healgen

Healgen Scientific, a wholly-owned subsidiary of Zhejiang Orient Gene Biotech Co., Ltd., develops, manufactures and c... read more Featured Products: More products

Download Mobile App





Healgen’s COVID-19 IgG/IgM Rapid Test Kit Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 03 Jun 2020
Print article
Image: The Healgen COVID-19 IgG/IgM rapid test cassette (Photo courtesy of Healgen Scientific, LLC)
Image: The Healgen COVID-19 IgG/IgM rapid test cassette (Photo courtesy of Healgen Scientific, LLC)
Healgen Scientific, LLC’s (Houston, TX, USA) COVID-19 IgG/IgM Rapid Test Kit has been granted Emergency Use Authorization (EUA) by the US Food and Drug Administration (FDA).

As a result of the FDA authorization, Confirm BioSciences (San Diego, CA, USA), the largest North American distributor for Healgen, a subsidiary of Zhejiang Orient Gene Biotech, maker of the COVID-19 test, will have an ample supply of test kits for medical professional use starting in early June. Confirm expect to have millions of tests available, enough to satisfy existing pre-orders and future orders. Zhejiang has also appointed Aytu BioScience, Inc. (Englewood, CO, USA) as the US distributor for the COVID-19 test and has delivered more than 1.4 million rapid tests to the company for distribution in the country.

An easy-to-use test kit that provides results in just 10 minutes, COVID-19 IgG/IgM Rapid Test kits are designed for use with whole blood, serum or plasma samples. With a high degree of accuracy, the kits detect IgM that may appear in blood within three-five days following incubation and IgG that appears as soon as 1-2 weeks. As part of the FDA review, a National Institutes of Health (NIH) study comparing rapid test kits found that the COVID-19 Rapid Test demonstrated excellent performance. The tests are authorized for prescription use only for use in high or moderately complex CLIA laboratories. The kits have a shelf life of 24 months from the date of manufacture and can be stored at room temperature or in a refrigerator.

"We have received positive feedback on the test from our customers and independent studies, so the FDA Emergency Use Authorization validates what we already knew from real-world clinical applications," said Albert Berger, Chief Executive Officer, Confirm BioSciences. "This pandemic is an enormous challenge for medical professionals and everyone else, and as a major distributor, we're proud to do our part to increase testing capacity so that healthcare professionals can help contain the spread of the virus."


Print article

Channels

Copyright © 2000-2020 Globetech Media. All rights reserved.