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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.

FDA EUA
SARS-CoV-2 IgG

Intended UsE 1,2

The SARS-CoV-2 IgG assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (ACD, CPD, CPDA-1, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium citrate, sodium heparin). The SARS-CoV-2 IgG assay is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. The SARSCoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, to perform moderate or high complexity test.

Results are for the detection of SARS CoV-2 antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.

The sensitivity of SARS-CoV-2 IgG early after infection is unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

False positive results for SARS-CoV-2 IgG assay may occur due to cross-reactivity from pre-existing antibodies or other possible causes.

The SARS-CoV-2 IgG assay is only for use under the Food and Drug Administration’s Emergency Use Authorization.

See below for important safety information. 

 

Download SARS-CoV-2 IgG EUA Resources

download-icon_20x20.png Fact Sheet for Recipients: Understanding the Abbott SARS-C0V-2 IgG EUA Assay Results download-icon_20x20.png Fact Sheet for Healthcare Providers: Interpreting Abbott SARS-CoV-2 IgG EUA Assay Results

 

 

 

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 foot 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.

 

 

 

 

Ordering Information

Visit our e-commerce website to quickly and efficiently order
SARS-CoV-2 IgG assays online.

Order Here  

 For more information contact your Abbott Representative.


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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. 

Important Safety Information
 
  • For In Vitro Diagnostic Use Only.
  • Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from these instructions. 
  • For laboratory professional use only. 

For use under an Emergency Use Authorization (EUA) Only: 

  • Prescription Use only.
  • This test has not been FDA cleared or approved.
  • This test has been authorized by FDA under EUA for use by authorized laboratories.
  • This test has been authorized only for the detection of IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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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