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
Sign In
Advertise with Us
INTEGRA BIOSCIENCES AG

Download Mobile App





Seasun Biomaterials Secures FDA Emergency Use Authorization for Second COVID-19 Rapid Detection Kit

By LabMedica International staff writers
Posted on 25 May 2020
Print article
Image: AQ-TOP™ COVID-19 Rapid Detection Kit (Photo courtesy of Seasun Biomaterials, Inc.)
Image: AQ-TOP™ COVID-19 Rapid Detection Kit (Photo courtesy of Seasun Biomaterials, Inc.)
Seasun Biomaterials, Inc. (Daejeon, Korea) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration for its second COVID-19 assay AQ-TOP COVID-19 Rapid Detection Kit following the completion of FDA EUA (April-27) of its U-TOP COVID-19 Real-Time Detection Kit.

The AQ-TOP technology enhances analytical speed, sensitivity and specificity of the conventional molecular methods by combining isothermal amplification and PNA (Peptide Nucleic Acid) detection probe, which has high accurate binding efficiency to the target nucleic acid. This kit targets the ORF1ab gene of the SARS-CoV-2 with an endogenous control human RNase P gene. Customers need not purchase any additional equipment and can use their existing real-time PCR instrument which is frequently used for COVID-19 diagnosis. The average number of specimens that can be tested per unit (12 hours per day) is 3,400, which is 5-6 times faster than before. The company now plans to provide the kit globally and hopes that its advantage of rapid COVID-19 diagnosis will contribute to quick follow up.

Related Links:
Seasun Biomaterials, Inc.

Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
HLX
POCT Fluorescent Immunoassay Analyzer
FIA Go
New
Gold Member
COVID-19 Rapid Test
AQ+ COVID-19 Ag Rapid Test

Print article

Channels

Clinical Chemistry

view channel
Image: Reaching speeds up to 6,000 RPM, this centrifuge forms the basis for a new type of inexpensive, POC biomedical test (Photo courtesy of Duke University)

POC Biomedical Test Spins Water Droplet Using Sound Waves for Cancer Detection

Exosomes, tiny cellular bioparticles carrying a specific set of proteins, lipids, and genetic materials, play a crucial role in cell communication and hold promise for non-invasive diagnostics.... Read more

Molecular Diagnostics

view channel
Image: The cobas Malaria test is the first FDA-approved molecular test to screen U.S. blood donors for malaria (Photo courtesy of Roche)

First FDA-Approved Molecular Test to Screen Blood Donors for Malaria Could Improve Patient Safety

Malaria, a serious illness that often leads to death, is spread by a specific mosquito species that infect humans with a parasite. Other transmission modes include blood transfusions, organ transplants,... Read more

Hematology

view channel
Image: The low-cost portable device rapidly identifies chemotherapy patients at risk of sepsis (Photo courtesy of 52North Health)

POC Finger-Prick Blood Test Determines Risk of Neutropenic Sepsis in Patients Undergoing Chemotherapy

Neutropenia, a decrease in neutrophils (a type of white blood cell crucial for fighting infections), is a frequent side effect of certain cancer treatments. This condition elevates the risk of infections,... Read more

Pathology

view channel
Image: The medical office procedure detects the key biomarker in Parkinson’s and related neurodegenerative diseases (Photo courtesy of BIDMC)

Simple Skin Biopsy Test Detects Parkinson’s and Related Neurodegenerative Diseases

Parkinson's disease and a group of related neurodegenerative disorders known as synucleinopathies impact millions globally. These conditions, including Parkinson’s disease (PD), dementia with Lewy bodies... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.