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

BIOHIT Healthcare OY

Offers technologies and services for diagnosing and preventing gastrointestinal diseases and associated risks read more Featured Products: More products

Download Mobile App

Biohit's SARS-CoV-2 IgM/IgG Antibody Test Kit Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 25 Jun 2020
Print article
Image: Biohit`s SARS-CoV-2 IgM/IgG Antibody Test Kit (Photo courtesy of Biohit Healthcare)
Image: Biohit`s SARS-CoV-2 IgM/IgG Antibody Test Kit (Photo courtesy of Biohit Healthcare)
Biohit Healthcare’s (Helsinki, Finland) SARS-CoV-2 IgM/IgG antibody test kit has been authorized by the FDA under a EUA (Emergency Use Authorization) for use in laboratories certified by CLIA (Clinical Laboratory Improvement Amendments of 1988).

EUA authorization is given only to products that have met FDA's rigid criteria showing these tests may be effective in detecting recent or prior infection by identifying individuals with an adaptive immune response to the virus that causes COVID-19 disease. In an independent study by a FDA-designated agency using frozen positive and negative antibody serum samples, Biohit’s SARS-CoV-2 IgM/IgG Antibody Test Kit was estimated to show a very high IgM and IgG sensitivity as well as a very high specificity. It is also a rapid test, giving results within minutes.

For critically ill COVID-19 patients, the FDA has authorized the transfusion of convalescent plasma (CP) to improve the patient's outcome. CP obtained from former COVID-19 patients who have been free of symptoms for more than 14 days, has shown to be extremely effective in helping the seriously ill recover.

"The utilization of the Biohit SARS-CoV-2 IgM/IgG antibody test kit can play an integral role in the selection of CP donors," said Frederick M. Schaffer M.D., Board certified Immunologist, formerly an Associate Professor at the Medical University of South Carolina. "CP is thought to diminish the morbidity and mortality associated with COVID-19 infections."

Additionally, a Yale University study in respect to Biohit concluded, "Overall, this LFA (lateral flow immunoassay) shows promise for use as a mobile diagnostic tool, and underscores the potential utility of such a simple and cost-effective assay for cataloging epidemiological data like prevalence and past infection status."

Print article


Molecular Diagnostics

view channel
Image: Schematic representation of Chiari malformation type 1; it involves the lower part of the cerebellum known as tonsils, but not the brain stem (Photo courtesy of Healthline).

Common Brain Malformation Traced to Its Genetic Roots

About one in 100 children has a common brain disorder called Chiari 1 malformation, but most of the time such children grow up normally and no one suspects a problem. However about one in 10 of those children,... Read more


view channel
Image: uPath HER2 Dual ISH image analysis for breast cancer (Photo courtesy of Roche)

Roche Launches Digital Pathology Image Analysis Algorithms for Precision Patient Diagnosis in Breast Cancer

Roche (Basel, Switzerland) has announced the CE-IVD launch of its automated digital pathology algorithms, uPath HER2 (4B5) image analysis and uPath Dual ISH image analysis for breast cancer to help determine... Read more
Copyright © 2000-2021 Globetech Media. All rights reserved.