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Sars-cov-2 immunoassays

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Sars-cov-2 immunoassays image
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Advancing diagnostics of covid-19

Understanding if a patient has been recently or previously infected with SARS-CoV-2, how long antibodies stay in the body, and how an individual immune response reacted to the vaccine are important steps in the COVID-19 pandemic. Serology tests can provide this broader picture. Abbott has partnered with laboratories around the world by quickly developing assays for the specific detection of SARS-CoV-2 antibodies. These tests are produced in the volumes required to support the urgent needs of laboratories in their mission to support ongoing patient care.

 

Learn more about our FDA Emergency Use Authorized SARS-CoV-2 assays below.

Background

Designed to detect IgG antibodies to the receptor binding domain (RBD) of the S1 subunit of the spike protein of SARS-CoV-2, AdviseDx SARS-CoV-2 IgG II produces a qualitative and semi-quantitative result across a broad and reliable measuring interval.1,2  As we enter the next phase of COVID-19 mitigation, understanding immune responses through not just antibody detection but also having an estimate of how much of the measured antibody is present (e.g. semi-quantitative result), may help determine and quantify what level would constitute a protective titer, which would be important to the ongoing management of COVID-19.

Intended use 1,2

The AdviseDx SARS-CoV-2 IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS-CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin) on the ARCHITECT and Alinity i system. The AdviseDx SARS-CoV-2 IgG II 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 AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection.

Specific performance characteristics 

Clinical performance 1,2

Analytical specificity: No cross-reactivity observed from individuals with other medical conditions, including Human Coronavirus 229E, HKU1, NL63, or OC43.1,2

Background

The presence of IgM antibodies allows for the identification of recent infection and evaluation of disease course. Specific IgM antibodies to SARS-CoV-2 may be detectable in COVID-19 patients during the symptomatic phase of the disease. 3,4

The AdviseDx SARS-CoV-2 IgM assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative detection of IgM antibodies to SARS-CoV-2 in human serum, serum separator tube and plasma (dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin separator tube, sodium heparin). The AdviseDx SARS-CoV-2 IgM 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 AdviseDx SARS-CoV-2 IgM assay should not be used to diagnose acute SARS-CoV-2 infection. 5,6

Click here to view important safety information

Clinical performance 5

Background

The persistence of immunoglobulin class G (IgG) antibodies allows identification of people who have been infected in the past, recovered from the illness, and possibly developed immunity.7 Therefore, SARS-CoV-2 IgG immunoassays play an important role in research and surveillance.8

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 SARS-CoV-2 IgG assay should not be used to diagnose acute SARS-CoV-2 infection.9,10

Click here to view important safety information

Clinical performance 9,10      

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

aFive 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

More than 60,000 samples have been evaluated with Abbott’s SARS-CoV-2 assays in more than 20 publication/evaluations, seeking to provide key insights. Here are a few examples.

Check back frequently for more resources.

PublicationDescription
Performance Characteristics of the Abbott Architect SARS-CoV-2 IgG Assay and Seroprevalence in Boise, Idaho
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.
Prevalence of SARS-CoV-2 in Spain (ENE-COVID): a nationwide, population-based seroepidemiological study
Study published in The Lancet showed how our SARS-CoV-2 IgG assay was recently involved in one of the largest (if not the largest) seroprevalence studies in Europe and it helped Spanish government determine what has happened and inform national and local public health policies. 
SARS-CoV-2 seroprevalence and neutralizing activity in donor and patient blood from the San Francisco Bay Area
Researchers from University of California, San Francisco, provided evidence that seropositive results using the Architect SARS CoV-2 anti-nucleocapsid protein IgG (EUA) and anti-spike IgM (prototype) assays are generally predictive of in vitro neutralizing capacity.

 

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 assays are 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.

Alinity immunoassay systems Image
Alinity immunoassay systems Image
Alinity immunoassay systems Image

Architect immunoassay systems

Abbott's SARS-CoV-2 assays are 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.

 

Architect immunoassay systems image
Architect immunoassay systems image
Architect immunoassay systems image
Ordering information

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

Order here

For more information contact your representative at Abbott.

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. 

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 IMPORTANT SAFETY INFORMATION
  • For In Vitro Diagnostic Use Only. 
  • The results of this semi-quantitative test should not be interpreted as an indication or degree of immunity or protection from infection.
  • Instructions must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations from instructions. 
  • For laboratory professional use only.

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

  • These tests have not been FDA cleared or approved.
  • These tests have been authorized by FDA under EUA for use by authorized laboratories.
  • These tests have been authorized only for the detection of the presence of IgG antibodies or IgM antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  • These tests are 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.
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References
  1. Abbott ARCHITECT Advise DX SARS-CoV-2 IgG II Reagent Instructions for Use. April 2022.
  2.  Abbott Alinity i Advise DX SARS-CoV-2 IgG II Reagent Instructions for Use. April 2022
  3.  Zhao J, et al. Antibody responses to SARS-CoV-2 in patients of novel coronavirus disease 2019. Clin Inf Dis Accepted Manuscript. Published online March 28, 2020. doi:10.1093/cid/ciaa344.
  4.  Xiao AT, Gao C, Zhang S. Profile of specific antibodies to SARSCoV-2: the first report. J Infect 2020. doi:10.1016/j.jinf.2020.03.012.
  5.  Abbott AdviseDx SARS-CoV-2 IgM Reagent (ARCHITECT) Instructions for Use. September 2021.
  6.  Abbott AdviseDx SARS-CoV-2 IgM Reagent (Alinity i) Instructions for Use. September 2021.
  7.  Shen C, Wang Z, Zhao F, et al. Treatment of 5 critically ill patients with COVID-19 with convalescent plasma. JAMA Published online March 27, 2020. doi:10.1001/jama.2020.4783.
  8.  World Health Organization. Laboratory testing strategy recommendations for COVID-19: interim guidance, March 21, 2020. World Health Organization; 2020.
  9.  Abbott ARCHITECT SARS-CoV-2 IgG Reagent Instructions for Use. May 2022.
  10.  Abbott Alinity i SARS-CoV-2 IgG Reagent Instructions for Use. May 2022.
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