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





Hardy Diagnostics Releases Autobio’s One-Step Test for COVID-19

By LabMedica International staff writers
Posted on 31 Mar 2020
Hardy Diagnostics (Santa Maria, CA, USA), an FDA-licensed manufacturer of medical devices for microbiological testing, has begun accepting orders for a new rapid, one-step lateral flowassay that detects both IgG and IgM antibodies to the SARS-CoV-2 virus. More...
The immunoassay intended specifically for determining the possibility of a COVID-19 infection was developed by Autobio Diagnostics Co., Ltd. (Zhengzhou, Henan, China), a microbiology medical device manufacturer. Hardy Diagnostics has entered into a strategic partnership with Autobio Diagnostics to become a US supplier of the new in vitro diagnostic medical device, Anti-SARS-CoV-2 Rapid Test.

The Anti-SARS-CoV-2 Rapid Test is a rapid, one-step lateral flow assay intended for the presumptive qualitative detection of IgM and IgG antibodies to the SARS-CoV-2 virus in patients suspected of a COVID-19 infection. By using a patient’s finger prick blood, serum, or plasma specimen, the Anti-SARS-CoV-2 Rapid Test offers a turnaround time of only 15 minutes. The simple-to-use test requires no equipment or special expertise or training to implement.

Through their partnership, Hardy Diagnostics and Autobio Diagnostics have begun opening up supply chains to deliver this rapid test to the US. The rapid market deployment of the new in vitro diagnostic medical device was made possible through the FDA Emergency Use Authorization (EUA) program, allowing for its simultaneous commercialization while the product is still under review, which enables Hardy Diagnostics to supply the test during this critical time.

“We are incredibly proud of the work our partners in China have accomplished,” said Andre Hsiung, Director of Technical Services at Hardy Diagnostics. “Because Autobio quickly developed this technology and because the FDA allowed Emergency Use Authorization, we will be able to more effectively leverage our sales network to get this product out to where it is needed the most.”

Related Links:
Hardy Diagnostics
Autobio Diagnostics Co., Ltd.



Gold Member
Universal Transport Solution
Puritan®UniTranz-RT
Portable Electronic Pipette
Mini 96
Gold Member
Immunochromatographic Assay
CRYPTO Cassette
Laboratory Software
ArtelWare
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 CloneSeq-SV approach can allow researchers to study how cells within high-grade serous ovarian cancer change over time (Photo courtesy of MSK)

Blood Test Tracks Treatment Resistance in High-Grade Serous Ovarian Cancer

High-grade serous ovarian cancer (HGSOC) is often diagnosed at an advanced stage because it spreads microscopically throughout the abdomen, and although initial surgery and chemotherapy can work, most... Read more

Pathology

view channel
Image: The new system allows surgeons to identify genotyping of brain tumors and determine optimal resection margins during surgery (Photo courtesy of Nagoya University)

New Technique Detects Genetic Mutations in Brain Tumors During Surgery within 25 Minutes

Determining the genetic profile of brain tumors during surgery is crucial for improving patient outcomes, but conventional analysis methods can take up to two days, delaying critical decisions.... Read more

Industry

view channel
Image: The collaboration aims to improve access to Hb variant testing with the Gazelle POC diagnostic platform (Photo courtesy of Hemex Health)

Terumo BCT and Hemex Health Collaborate to Improve Access to Testing for Hemoglobin Disorders

Millions of people worldwide living with sickle cell disease and other hemoglobin disorders experience delayed diagnosis and limited access to effective care, particularly in regions where testing is scarce.... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.