SARS-COV-2 Immunoassays

Advancing Diagnostics of Covid-19

Understanding if a patient has been recently or 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 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 SARS-CoV-2 IgM and IgG assays by selecting the tabs below.

SARS-COV-2 IgM
 

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BACKGROUND

The presence of IgM antibodies allows for the identification of recent infection and evaluation of disease course. Accompanying an antibody test with an RNA test improves overall sensitivity of the viral diagnosis in the early stage of the infection.1





INTENDED USE 2,3

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

The SARS-CoV-2 IgM 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 IgM assay should not be used as the sole basis for diagnosis.

 

CLINICAL PERFORMANCE 2

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The positive agreement between the ARCHITECT i2000sr and the Alinity i was 100.00% and the negative agreement was 99.97%.3 

aTwenty-eight (28) specimens from 8 immunocompromised patient were excluded from the study. Refer to the LIMITATIONS OF THE PROCEDURE section of this package insert for further information. When the results from these specimens were included, the PPA at ≤ 7 days post-symptom onset was 45.26% (95% CI: 35.63, 55.26), the PPA at 8 - 14 days post-symptom onset was 79.56% (95% CI: 72.05, 85.46), the PPA at 15 - 30 days post-symptom onset was 91.26% (95% CI: 84.22, 95.33), and the PPA at ≥ 31 days post-symptom onset was 94.74% (95% CI: 75.36, 99.73). bDuration of the IgM antibody response has not been fully characterized.

SARS-Cov-2 IGG
 

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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.4 Therefore, SARS-CoV-2 IgG immunoassays play an important role in research and surveillance.5





INTENDED USE 6,7

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 6,7

chart1_post-symptom-onset.png           chart2_negative-agreement.png

 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).

SARS-CoV-2 IgG II Quant
 

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BACKGROUND

Research is ongoing to establish the extent to which IgG antibodies to SARS-CoV-2, and in particular neutralizing antibodies, confer immunity to infection. The ability to longitudinally detect and quantitate antibodies which are associated with neutralization of the virus will become increasingly important as vaccines and therapeutics gain widespread use.8

A wide range of COVID-19 vaccines in development utilize strategies that generate antibody response to the spike protein and the RBD domain of the S1 subunit.9

Plasma from convalescent donors with neutralizing levels of specific IgG has shown some efficacy in limiting the consequences of COVID-19.4 Several studies have alluded to the potential of antibody testing, correlated to neutralizing antibody titers, as part of the evaluation of convalescent COVID plasma (CCP) to assess potency and efficacy of the product.10,11




INTENDED USE 12, 13

The SARS-CoV-2 IgG II Quant assay is a chemiluminescent microparticle immunoassay (CMIA) used for the qualitative and quantitative determination of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Alinity and ARCHITECT i Systems. The SARS-CoV-2 IgG II Quant 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. The assay is also to be used as an aid in evaluating immune status of individuals with quantitative measurement of IgG antibodies against the spike receptor-binding domain (RBD) of SARS-CoV-2. Results from the SARS-CoV-2 IgG II Quant assay should not be used as the sole basis for diagnosis.

 

 

CLINICAL PERFORMANCE 

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* Plaque reduction neutralization test [PRNT] at the Broad Institute.
Positive % agreement = 100.0% (86/86) 95% CI (95.72 – 100.00)

Analytical specificity: No cross-reactivity observed from individuals with other medical conditions, including Human Coronavirus 229E, HKU1, NL63, or OC43.12,13

 



Related Publications

More than 60,000 samples have been evaluated with Abbott’s SARS-CoV-2 assays in more than 30 publication/evaluations, seeking to provide key insights. Here are a few examples.

 

Check back frequently for more resources.

 

Publication Description
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. 
Longitudinal characterization of the IgM and IgG humoral response in symptomatic COVID-19 patients using the Abbott Architect Researchers from Beaumont Health, Michigan, summarized that the combined use of IgM and IgG testing is useful to support a diagnosis of COVID-19 most notably in symptomatic individuals who test negative by molecular detection methods.

 

 
 

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.

 

 
 

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.

 

 

 

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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. We look forward to delivering more key SARS-CoV-2 serologic tools in the months to come.  


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References
  1. 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.
  2. Abbott ARCHITECT SARS-CoV-2 IgM Instructions for Use, H07914R01. August 2020.
  3. Abbott Alinity i SARS-CoV-2 IgM Instructions for Use, H16130R01. August 2020.
  4. 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.
  5. World Health Organization. Laboratory testing strategy recommendations for COVID-19: interim guidance, March 21, 2020. World Health Organization; 2020.
  6. Abbott ARCHITECT SARS-CoV-2 IgG Instructions for Use. H14806R03. May 2020.
  7. Abbott Alinity i SARS-CoV-2 IgG Instructions for Use. H07943R02. May 2020.
  8. Rogers TF, Zhao F, Huang D, et al. Isolation of potent SARS-CoV-2 neutralizing antibodies and protection from disease in a small animal model. Science 2020;369(6506):956-963.
  9. Krammer, F. SARS-CoV-2 vaccines in development. Nature 2020;586(7380):516-527.
  10. Grzelak L, et al. A comparison of four serological assays for detecting anti-SARS-CoV-2 antibodies in human serum samples from different populations. Sci Transl Med 2020:12(559).
  11. DomBourian, et al. Analysis of COVID-19 convalescent plasma for SARS-CoV-2 IgG using two commercial immunoassays. J Immunol Methods Accepted manuscript. Published online 20 August 2020.
  12. Abbott ARCHITECT SARS-CoV-2 IgG II Quant Reagent Instructions for Use. December 2020.
  13. Abbott Alinity i SARS-CoV-2 IgG II Quant Reagent Instructions for Use. December 2020.

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