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





BD Receives CE Mark for Portable, Rapid Point-of-Care COVID-19 Antigen Test That Detects SARS-CoV-2 in 15 Minutes

By LabMedica International staff writers
Posted on 01 Oct 2020
Becton, Dickinson and Company’s (BD Franklin Lakes, NJ, USA) rapid, point-of-care, SARS-CoV-2 antigen test for use on the BD Veritor Plus System has been CE marked to the IVD Directive (98/79/EC).

The new test delivers results in 15 minutes on an easy-to-use, portable instrument, which is a critical improvement in turnaround time for COVID-19 diagnostics, because it provides real-time results and enables decision-making while the patient is still onsite. More...
The company expects commercial availability of this new assay at the end of October for countries in Europe that recognize the CE mark. The European Centre for Disease Prevention and Control (ECDC) recently released guidance that all patients with acute respiratory symptoms should be tested for both SARS-CoV-2 and influenza A+B in parallel during flu season1. The BD Veritor Plus System can test for both infections on the same platform.

The test, which has been available in the US since July through an Emergency Use Authorization by the US Food and Drug Administration (FDA), uses the BD Veritor Plus System, which is already in use across Europe to test for conditions such as Group A Strep, influenza A+B and Respiratory Syncytial Virus (RSV). The BD Veritor Plus System, which is slightly larger than a mobile phone, offers an easy-to-use workflow that makes it an ideal solution for point-of-care settings. It also offers customers traceability and reporting capabilities through the optional BD Synapsys informatics solution. BD is leveraging its global manufacturing network and scale to produce eight million SARS-CoV-2 antigen tests per month by October and expects to produce 12 million tests per month by March 2021.

"Availability of the SARS-CoV-2 assay on the BD Veritor Plus System in Europe builds on our molecular test on the BD MAX System that has been available since March," said Roland Goette, president of BD EMEA Region. "The addition of a truly portable, point-of-care test that can deliver results while the patient waits will be welcomed by health care providers and patients alike to help protect against additional waves of COVID-19."

Related Links:
Becton, Dickinson and Company


Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
Portable Electronic Pipette
Mini 96
New
Hemodynamic System Monitor
OptoMonitor
New
Alcohol Testing Device
Dräger Alcotest 7000
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

Clinical Chemistry

view channel
Image: The study highlights the potential of cCAFs as a biomarker for early diagnosis and prognosis (H J Woo et al., Analytical Chemistry (2025). DOI: 10.1021/acs.analchem.5c02154)

Simultaneous Cell Isolation Technology Improves Cancer Diagnostic Accuracy

Accurate cancer diagnosis remains a challenge, as liquid biopsy techniques often fail to capture the complexity of tumor biology. Traditional systems for isolating circulating tumor cells (CTCs) vary in... Read more

Hematology

view channel
Image: New research points to protecting blood during radiation therapy (Photo courtesy of 123RF)

Pioneering Model Measures Radiation Exposure in Blood for Precise Cancer Treatments

Scientists have long focused on protecting organs near tumors during radiotherapy, but blood — a vital, circulating tissue — has largely been excluded from dose calculations. Each blood cell passing through... Read more

Immunology

view channel
Image: The VENTANA HER2 (4B5) test is now CE-IVDR approved (Photo courtesy of Roche)

Companion Diagnostic Test Identifies HER2-Ultralow Breast Cancer and Biliary Tract Cancer Patients

Breast cancer is the most common cancer in Europe, with more than 564,000 new cases and 145,000 deaths annually. Metastatic breast cancer is rising in younger populations and remains the leading cause... Read more

Technology

view channel
Image: Conceptual design of the CORAL capsule for microbial sampling in the small intestine (H. Mohammed et al., Device (2025). DOI: 10.1016/j.device.2025.100904)

Coral-Inspired Capsule Samples Hidden Bacteria from Small Intestine

The gut microbiome has been linked to conditions ranging from immune disorders to mental health, yet conventional stool tests often fail to capture bacterial populations in the small intestine.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.