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 hp
Sign In
Advertise with Us
PURITAN MEDICAL

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
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. More...
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."



Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
PlGF Test
Quidel Triage PlGF Test
New
Drug Test Kit
DrugCheck 3000
Read the full article by registering today, it's FREE! It's Free!
Register now for FREE to LabMedica.com and get access to news and events that shape the world of Clinical Laboratory Medicine.
  • Free digital version edition of LabMedica International sent by email on regular basis
  • Free print version of LabMedica International magazine (available only outside USA and Canada).
  • Free and unlimited access to back issues of LabMedica International in digital format
  • Free LabMedica International Newsletter sent every week containing the latest news
  • Free breaking news sent via email
  • Free access to Events Calendar
  • Free access to LinkXpress new product services
  • REGISTRATION IS FREE AND EASY!
Click here to Register








DIASOURCE (A Biovendor Company)

Channels

Molecular Diagnostics

view channel
Image: The new RABTA sets a high standard in laboratory diagnostics (Photo courtesy of Randox)

Pioneering Analyzer with Advanced Biochip Technology Sets New Standard in Lab Diagnostics

A state-of-the-art analyzer combines advanced technology with exceptional efficiency to meet the demanding needs of modern laboratories. Randox Toxicology (Antrim, Ireland) has launched its pioneering... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: How the predictive test works (Photo courtesy of QMUL)

World’s First Clinical Test Predicts Best Rheumatoid Arthritis Treatment

Rheumatoid arthritis (RA) is a chronic condition affecting 1 in 100 people in the UK today, causing the immune system to attack its joints. Unlike osteoarthritis, which is caused by wear and tear, RA can... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.