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
LGC Clinical Diagnostics

Download Mobile App





FDA Grants EUA to One of the First Tests That Measures Specific Levels of COVID-19 Neutralizing Antibodies

By LabMedica International staff writers
Posted on 26 Nov 2020
Print article
Illustration
Illustration
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) to one of the first tests that measures specific levels of COVID-19 neutralizing antibodies.

COVID-SeroKlir, a semi-quantitative SARS-CoV-2 IgG antibody test kit from Kantaro Biosciences, LLC (New York, NY, USA), a joint venture between the Mount Sinai Health System (New York, NY, USA) and Renalytix AI (New York, NY, USA), has been granted EUA by the FDA. Unlike other antibody tests, COVID-SeroKlir determines the presence and precise level of IgG antibodies and has a broad range of applications in the fight against COVID-19. Through a commercial partnership with Bio-Techne Corporation (Minneapolis, MN, USA), the test kits are being manufactured at scale with a capacity of up to 10 million tests per month and the ability to scale up.

COVID-SeroKlir is a two-step enzyme-linked immunosorbent assay (ELISA) and can be used by any CLIA-certified laboratory without the need for proprietary equipment. Mount Sinai developed the underlying technology in COVID-SeroKlir, which has been used and validated in a highly diverse population of over 80,000 patient samples. COVID-SeroKlir has demonstrated 98.8% sensitivity and 99.6% specificity for detecting SARS-CoV-2 specific IgG antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain. The Kantaro test kit received CE mark in October 2020 and is available in 29 countries in Europe.

Measuring IgG antibody levels with COVID-SeroKlir can inform healthcare decision-making and public health strategies, as well as assess vaccine response. Semi-quantitative antibody testing is also an essential component of a general health check to determine past COVID-19 infections. An increased risk of potentially life-threatening complications, including lung, kidney, and cardiovascular disease, has been linked to COVID-19.

"COVID-SeroKlir is based on Mount Sinai technology that was developed at the height of the COVID-19 pandemic in New York City," said Sara Barrington, Kantaro's chief commercial officer. "It is a high performing test that quantifies antibody levels for individuals, which medical professionals and policymakers alike can trust. Having a numerical understanding of antibody levels can be especially powerful for patients, enabling them to take control of their health and enjoy some peace of mind during these uncertain times."

Related Links:
Kantaro Biosciences, LLC
Mount Sinai Health System
Renalytix AI
Bio-Techne Corporation


Platinum Member
COVID-19 Rapid Test
OSOM COVID-19 Antigen Rapid Test
Specimen Collection & Transport
POCT Fluorescent Immunoassay Analyzer
FIA Go
Gold Member
SARS‑CoV‑2/Flu A/Flu B/RSV Sample-To-Answer Test
SARS‑CoV‑2/Flu A/Flu B/RSV Cartridge (CE-IVD)

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: MOF materials efficiently enrich cfDNA and cfRNA in blood through simple operational process (Photo courtesy of Science China Press)

Blood Circulating Nucleic Acid Enrichment Technique Enables Non-Invasive Liver Cancer Diagnosis

The ability to diagnose diseases early can significantly enhance the effectiveness of clinical treatments and improve survival rates. One promising approach for non-invasive early diagnosis is the use... 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 OvaCis Rapid Test discriminates benign from malignant epithelial ovarian cysts (Photo courtesy of INEX)

Intra-Operative POC Device Distinguishes Between Benign and Malignant Ovarian Cysts within 15 Minutes

Ovarian cysts represent a significant health issue for women globally, with up to 10% experiencing this condition at some point in their lives. These cysts form when fluid collects within a thin membrane... Read more
Copyright © 2000-2024 Globetech Media. All rights reserved.