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
INTEGRA BIOSCIENCES AG

Download Mobile App





First True POC COVID-19 Antibody Tests Offer Convenience and Ease of Use

By LabMedica International staff writers
Posted on 16 Jun 2020
Two newly-launched rapid COVID-19 antibody tests are awaiting Emergency Use Authorization (EUA) approval from the US FDA and once authorized, would become the first true point-of-care (POC) tests designed for convenience and ease of use, allowing providers to triage their patients as efficiently as possible.

Vivera Pharmaceuticals, Inc. More...
(Newport Beach, CA, USA) has launched the POC ready rapid serology tests which are designed to serve where patients most critically require screening testing. One test is optimized for use in mass-screening settings, such as drive through testing centers, and the other test is more suitable for use in doctor's offices and health clinics. Following in the footsteps of its first EUA filing, Vivera is voluntarily taking part in the National Cancer Institute backed validation studies for its two new filings. Vivera plans to use its serology antibody tests to begin its forthcoming clinical trials in support of eventual medical device filings with the FDA as the company further expands its advanced diagnostics division.

"Vivera has undergone clinical trials with nursing homes and health clinics and we have made refinements we feel will best serve the doctors and nurses who will be the ones using the test," stated Dr. Stephen McColgan, Vivera Pharmaceuticals' Chief Medical Officer. "Eventually, as the FDA finds the right pathway, we hope to transition into supporting telemedicine providers and expanding the availability of screening testing."


Related Links:
Vivera Pharmaceuticals, Inc.


Gold Member
Multiplex Genetic Analyzer
MassARRAY Dx Analyzer (Europe only)
Collection and Transport System
PurSafe Plus®
Silver Member
PCR Plates
Diamond Shell PCR Plates
Rapid Molecular Testing Device
FlashDetect Flash10
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: A schematic illustrating the coagulation cascade in vitro (Photo courtesy of Harris, N., 2024)

ADLM’s New Coagulation Testing Guidance to Improve Care for Patients on Blood Thinners

Direct oral anticoagulants (DOACs) are one of the most common types of blood thinners. Patients take them to prevent a host of complications that could arise from blood clotting, including stroke, deep... Read more

Microbiology

view channel
Image: EBP and EBP plus have received FDA 510(k) clearance and CE-IVDR Certification for use on the BD COR system (Photo courtesy of BD)

High-Throughput Enteric Panels Detect Multiple GI Bacterial Infections from Single Stool Swab Sample

Gastrointestinal (GI) infections are among the most common causes of illness worldwide, leading to over 1.7 million deaths annually and placing a heavy burden on healthcare systems. Conventional diagnostic... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.