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

Download Mobile App





BioMérieux SARS-CoV-2 Serology Tests Granted FDA Emergency Use Authorization

By LabMedica International staff writers
Posted on 11 Aug 2020
BioMérieux’s (Marcy-l'Étoile, France) has been granted Emergency Use Authorizations (EUAs) by the US Food and Drug Administration (FDA) for two SARS-CoV-2 serology tests.

The FDA has granted EUA to BioMérieux’s VIDAS SARS-COV-2 IgM and VIDAS SARS-COV-2 IgG automated qualitative assays which rapidly detect antibodies to help identify individuals with previous exposure to SARS-CoV-2. More...
With the same protocols to differentiate IgM and IgG results, the VIDAS SARS-COV-2 IgM detects IgM specific for SARS-CoV-2 while the VIDAS SARS-COV-2 IgG detects IgG specific for SARS-CoV-2.

Both the assays use a two-step sandwich enzyme immunoassay method with final fluorescence detection (ELFA). Available on-demand 24/7 on all VIDAS platforms, they offer flexibility and reliability for results in less than 30 minutes. All the assay steps are performed automatically by the instrument which is intuitive and easy to use with limited maintenance, calibration and controls. Both the assays deliver a performance with high specificity and sensitivity from day eight and generate results that help provide additional pandemic analysis data. According to the FDA, both the tests can be used by any lab CLIA-certified to perform moderate- or high-complexity testing.

Related Links:

BioMérieux


Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
Portable Electronic Pipette
Mini 96
Automated Chemiluminescence Immunoassay Analyzer
MS-i3080
Human Estradiol Assay
Human Estradiol CLIA Kit
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








Channels

Hematology

view channel
Image: New evidence shows viscoelastic testing can improve assessment of blood clotting during postpartum hemorrhage (Photo courtesy of 123RF)

Viscoelastic Testing Could Improve Treatment of Maternal Hemorrhage

Postpartum hemorrhage, severe bleeding after childbirth, remains one of the leading causes of maternal mortality worldwide, yet many of these deaths are preventable. Standard care can be hindered by delays... Read more

Immunology

view channel
Image: The TriVerity IVD test includes the TriVerity cartridge and the Myrna instrument (Photo courtesy of Inflammatix)

Blood-Based Immune Cell Signatures Could Guide Treatment Decisions for Critically Ill Patients

When a patient enters the emergency department in critical condition, clinicians must rapidly decide whether the patient has an infection, whether it is bacterial or viral, and whether immediate treatment... Read more

Technology

view channel
Image: The technology could be used for the early diagnosis of diseases such as cancers and Alzheimer\'s (Photo courtesy of PolyU)

3D Micro-Printed Sensors to Advance On-Chip Biosensing for Early Disease Detection

Early-stage disease diagnosis depends on the ability to detect biomarkers with exceptional sensitivity and precision. However, traditional biosensing technologies struggle with achieving this at the micro-scale,... Read more

Industry

view channel
Image: ELITechGroup’s unique Real-Time PCR technologies include the revolutionary Minor Groove Binder (Photo courtesy of ELITechGroup)

ELITech and Hitachi High-Tech to Develop Automated PCR Testing System for Infectious Diseases

Molecular testing has become central to diagnosing and monitoring infectious diseases by analyzing genetic information. The use of PCR during the COVID-19 pandemic showed its value, but traditional systems... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.