Beckman Coulter launches new COVID-19 IgG test

By LabPulse.com staff writers

May 20, 2021 -- Beckman Coulter announced it has launched its Access SARS-CoV-2 immunoglobulin G (IgG) test, a fully quantitative, lab-based, IgG serology test that measures the quantity of antibodies against the virus that causes COVID-19.

The assay is traceable to the First World Health Organization (WHO) International Standard for anti-SARS-CoV-2 immunoglobulin (human) and reports results directly aligned with the binding antibody units/milliliter (BAU/mL) standard established by the WHO.

The Access SARS-CoV-2 IgG test can be used in random-access mode and integrates into existing workflows without batch processing, according to the company. The test is available for immediate shipping to customers in countries accepting the CE Mark and to customers throughout the U.S. and Puerto Rico under the U.S. Food and Drug Administration's (FDA) Policy D.

The company reported it has filed an emergency use authorization for the assay with the FDA.

Beckman Coulter unveils new tabletop hematology analyzer
Beckman Coulter has introduced the DxH 560 AL, a tabletop hematology analyzer targeted at small and medium-sized labs.
Beckman Coulter launches high-throughput COVID-19 assay
Beckman Coulter has debuted a new COVID-19 test, the Access SARS-CoV-2 antigen assay, which the company said is cost-effective and has high throughput.
Beckman Coulter nabs EUA for COVID-19 IgM assay
The U.S. Food and Drug Administration has granted emergency use authorization (EUA) to Beckman Coulter's Access SARS-CoV-2 immunoglobulin M (IgM) assay,...
FDA grants Beckman Coulter EUA for assay test
The U.S. Food and Drug Administration (FDA) has awarded Beckman Coulter emergency use authorization (EUA) for its Access Interleukin-6 assay.
FDA clears Beckman Coulter's automated microplate system for blood banking
Beckman Coulter has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its automated microplate system and associated reagents.

Copyright © 2021 LabPulse.com

Last Updated ls 5/20/2021 3:38:00 PM