SARS-COV-2 Immunoassays

Advancing Diagnostics of Covid-19

Understanding if a patient has been previously infected with SARS-CoV-2 and how long antibodies stay in the body is an important next step in the fight against the virus. Serology tests can provide this broader picture. Abbott is partnering with laboratories around the world in the COVID-19 crisis by quickly bringing assays for the specific detection of SARS-CoV-2 antibody. These tests are produced in the volumes required to support the urgent needs of laboratories in their mission to support ongoing patient care.

 

CE Marked 
SARS-CoV-2 IgG


Intended UsE 1,2

The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Alinity i and ARCHITECT i Systems.

The SARS-CoV-2 IgG assay is to be used as an aid in the diagnosis of SARS-CoV-2 infection in conjunction with clinical presentation and other laboratory tests. Results from the SARS-CoV-2 IgG assay should not be used as the sole basis for diagnosis.

 

  

CLINICAL PERFORMANce 1,2

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 The positive agreement between the ARCHITECT i2000SR and the Alinity i was 100% and the negative agreement was 99.00%.

a Five specimens from 1 immunocompromised patient were excluded from the study. Refer to the LIMITATIONS OF THE PROCEDURE section of the package insert for further information. When the results from these specimens were included, the PPA at ≥ 14 days post-symptom onset was 96.77% (95% CI: 90.86, 99.33).

Related Publications

New research from the University of Washington, published in the Journal of Clinical Microbiology, found our SARS-CoV-2 IgG assay had 99.9% specificity and 100% sensitivity for detecting the IgG antibody in people 17 days after symptoms began.3

Read the Publication

 

Check back soon for more resources.

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ALINITY IMMUNOASSAY SYSTEMS

Alinity is your total laboratory solution, a unified, holistic family of systems designed to deliver unprecedented integration across your laboratory. The SARS-CoV-2 assay is available on the Alinity i, a compact, immunoassay system that maximizes throughput and processes more tests per square meter than other systems, making it one of the most efficient on the market today. 

Alinity is transforming labs around the world with clinical chemistry, immunoassay and integrated systems. To discover more visit the Alinity ci-series page.

 

 
 

ARCHITECT IMMUNOASSAY SYSTEMS

Abbott's SARS-CoV-2 IgG assay is also available on the high-throughput ARCHITECT i2000SR system, which can produce over 4,000 results in 24 hours, with a 29 minute time to first result. 

The ARCHITECT i2000SR and i1000SR meet your laboratory's high standards. For additional test menu, system specifications and resources visit the ARCHITECT Immunoassay Systems page.

 

 

 

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For more information contact your Abbott Representative.

 

    

COMPREHENSIVE TESTING SOLUTIONS

 

Abbott’s intention is to offer as many solutions as possible across our diagnostics platforms to help test millions of people around the world. To that end, we are also developing an IgM test for ARCHITECT and Alinity i. 

 

References
  1. Abbott ARCHITECT SARS-CoV-2 IgG Instructions for Use. H14806R01. April 2020
  2. Abbott Alinity i SARS-CoV-2 IgG Instructions for Use. H07943R01. May 2020
  3. Bryan A. et al. Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence Testing in Idaho. Journal of Clinical Microbiology May 2020, JCM.00941-20.

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