Name: SARS-CoV-2 IgG Antibody Test
Brand: BECKMAN COULTER, INC.

Covid-19 BECKMAN COULTER, INC.

Clinical Laboratory

SARS-CoV-2 IgG (1st IS) Test
Access SARS-CoV-2 IgG (1st IS)

The Access SARS-CoV-2 IgG (1st IS) is a fully-quantitative lab-based Immunoglobulin G (IgG) serology test that measures the quantity of antibodies against the virus that causes COVID-19. The assay is traceable to the 1st WHO International Standard for anti-SARS-CoV-2, 20/136 and reports results directly aligned with BAU/mL (Binding Antibody Units) established by the World Health Organization. The test can be used in Random Access Mode (RAM) and seamlessly integrated into existing workflows without batch processing. Results of the new quantitative antibody test are delivered on Beckman Coulter's immunoassay analyzers, including the DxI 800 high-throughput analyzer, which is capable of processing up to 200 Access SARS-CoV-2 IgG (1st IS) samples per hour.

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SARS-CoV-2 IgG Antibody Test
Access SARS-CoV-2 IgG Antibody Test

The Access SARS-CoV-2 IgG Antibody Test is designed to target antibodies against the coronavirus spike protein that may be more likely to confer immunity and detects antibodies to the RBD (Receptor Binding Domain) of the spike protein. The assay features market-leading 100% sensitivity‡ and 99.8% specificity, and is being validated against over 1,000 negative broad population-based samples.

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SARS-CoV-2 (COVID-19) Antibody Test
Access SARS-CoV-2 IgM Antibody Test

The Access SARS-CoV-2 IgM Antibody Test targets antibodies that recognize the receptor binding domain (RBD) of the spike protein which SARS-CoV-2 uses to bind to a human cell receptor. The IgM antibody test demonstrated 99.9% specificity against 1,400 negative samples and 98.3% sensitivity at 15-30 days post-symptom onset, and provides information about an individual's immune status with a positive predicative value of 95.5% in a population with disease incidence as low as 3%.

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SARS-CoV-2 IgG Antibody Test
Access SARS-CoV-2 IgG Antibody Test

The Access SARS-CoV-2 IgG antibody test detects antibodies to the RBD (Receptor Binding Domain) of the spike protein and can be run in random access mode, seamlessly integrating into current laboratory workflow without the need for batching or special maintenance. The test features market-leading sensitivity and specificity along with its throughput on Beckman Coulter immunoassay and integrated systems leading the industry at up to 200 tests per hour depending on the analyzer used (up to 4,800 tests/day).

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SARS-CoV-2 Antibody Test
Access SARS-CoV-2 IgG II Assay

The Access SARS-CoV-2 IgG II assay is a semi-quantitative and qualitative immunoassay that measures IgG antibodies directed to the receptor-binding domain of the spike protein of the novel coronavirus in response to a previous infection. The assay then provides a numerical result ranging from 2.00-450/mL1 as well as a qualitative result for SARS-CoV-2 IgG antibodies and can be used in Random Access Mode (RAM) as well as seamlessly integrated into existing workflows without batch processing.

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News of BECKMAN COULTER, INC.

Beckman Coulter Becomes First Diagnostics Company to Offer Workflow Automation Specifically for Mid-Volume Laboratories

05 May 2021

Beckman Coulter (Brea, CA, USA) has announced the global launch of the DxA 5000 Fit, a workflow-automation solution designed to fit into medium-sized labs that run fewer than 5,000 tests a day.

Beckman Coulter Launches New DxH 560 AL Tabletop Hematology Analyzer for Small- and Medium-Sized Labs

01 Feb 2021

Beckman Coulter (Brea, CA, USA) has launched the new DxH 560 AL, a tabletop hematology analyzer geared to reduce the time and resource constraints faced by small to mid-sized laboratories.

Beckman Coulter presenta una nueva solución de automatización total de laboratorios

29 May 2019

La última incorporación de Beckman Coulter (Brea, CA, EUA) a su cartera de automatización, la solución de automatización total de laboratorios, DxA 5000, ha logrado la aprobación de la Marca CE Europea y de la Administración de Alimentos y Medicamentos de China. El primero de un conjunto de sistemas DxA, actualmente en desarrollo, el DxA 5000 mejora la cartera completa de soluciones escalables de Beckman Coulter y es un componente clave de su visión para llevar la automatización del flujo de trabajo a los laboratorios de todos los tamaños.

Beckman Coulter Introduces New Total Laboratory Automation Solution

20 May 2019

Beckman Coulter’s latest addition to its automation portfolio, the DxA 5000 total laboratory automation solution has achieved European CE Mark and China Food and Drug Administration approval.

Beckman Coulter Life Sciences hace una sociedad con Apostle

05 Mar 2019

Beckman Coulter Life Sciences (Indianápolis, IN, EUA) se asoció con Apostle Inc. (Menlo Park, CA, EUA) para el lanzamiento del kit de aislamiento de ADN libre de células de alta eficiencia, MiniMax de Apostle, un kit magnético basado en nanopartículas para extraer ADN libre circulante (cfADN) del plasma mediante flujos de trabajo manuales o automáticos.

Beckman Coulter Life Sciences Enters Partnership with Apostle

01 Mar 2019

Beckman Coulter Life Sciences has entered into a partnership with Apostle Inc. for the launch of Apostle MiniMax High Efficiency Cell-Free DNA Isolation Kit, a magnetic nanoparticle-based kit to extract circulating free DNA (cfDNA) from plasma using manual or automated workflows.

Beckman Coulter lanza el Sistema ClearLLab 10C para los laboratorios de citometría de flujo

30 Jan 2019

Beckman Coulter (Brea, CA, EUA) ha lanzado el Sistema ClearLLab 10C para los laboratorios de citometría de flujo que incluye los primeros 10 paneles CE-IVD a color de reactivos de inmunotipificación tanto para el linaje linfoide como mieloide. Los cuatro paneles ClearLLab 10C fueron diseñados específicamente para ser procesados en los citómetros de flujo, Navios y Navios EX de Beckman Coulter, con el nuevo software avanzado de configuración de compensación, Navios.

Beckman Coulter Launches ClearLLab 10C System for Clinical Flow Cytometry Labs

23 Jan 2019

Beckman Coulter has launched the ClearLLab 10C System for clinical flow cytometry labs that includes the first 10-color CE-IVD panels of immunophenotyping reagents for both lymphoid and myeloid lineages.

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SARS-CoV-2 IgG Antibody Test

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