Features Partner Sites Information LinkXpress hp
Sign In
Advertise with Us
PURITAN MEDICAL

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
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. More...
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



Gold Member
Universal Transport Solution
Puritan®UniTranz-RT
3-Part Differential Hematology Analyzer
Swelab Alfa Plus Sampler
New
Gold Member
Serological Pipets
INTEGRA Serological Pipets
New
PlGF Test
Quidel Triage PlGF Test
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








DIASOURCE (A Biovendor Company)

Channels

Molecular Diagnostics

view channel
Image: The RNA-seq based diagnostic test for pediatric leukemia ensures better outcomes for children with this common cancer (Photo courtesy of Qlucore)

RNA-Seq Based Diagnostic Test Enhances Diagnostic Accuracy of Pediatric Leukemia

A new unique test is set to reshape the way Acute Lymphoblastic Leukemia (BCP-ALL) samples can be analyzed. Qlucore (Lund, Sweden) has launched the first CE-marked RNA-seq based diagnostic test for pediatric... Read more

Hematology

view channel
Image: CitoCBC is the world first cartridge-based CBC to be granted CLIA Waived status by FDA (Photo courtesy of CytoChip)

Disposable Cartridge-Based Test Delivers Rapid and Accurate CBC Results

Complete Blood Count (CBC) is one of the most commonly ordered lab tests, crucial for diagnosing diseases, monitoring therapies, and conducting routine health screenings. However, more than 90% of physician... Read more

Immunology

view channel
Image: A simple blood test could replace surgical biopsies for early detecion of heart transplant rejection (Photo courtesy of Shutterstock)

Blood Test Detects Organ Rejection in Heart Transplant Patients

Following a heart transplant, patients are required to undergo surgical biopsies so that physicians can assess the possibility of organ rejection. Rejection happens when the recipient’s immune system identifies... Read more
Copyright © 2000-2025 Globetech Media. All rights reserved.