Infectious Disease Assays
Our extensive assay menu helps physicians make timely, informed decisions throughout the continuum of care.
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 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.
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.1
A wide range of COVID-19 vaccines utilize strategies that generate antibody response to the spike protein and the RBD domain of the S1 subunit.2
Plasma from convalescent donors with neutralizing levels of specific IgG has shown some efficacy in limiting the consequences of COVID-19.3 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.4,5
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 infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine, by quantitatively measuring 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 of SARS-CoV-2 infection.
Our highly sensitive and specific SARS-CoV-2 IgG II Quant assay (positive and negative percent agreement tables below) has demonstrated the ability to detect the spike RBD-based vaccine response (Pfizer-BioNTech COVID-19 cohort represented in the chart below) in longitudinal samples from individuals both with and without prior COVID-19 infection.
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.8
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.
The positive agreement between the ARCHITECT i2000sr and the Alinity i was 100.00% and the negative agreement was 99.97%
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
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.3 Therefore, SARS-CoV-2 IgG immunoassays play an important role in research and surveillance.11
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.
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).
More than 60,000 samples have been evaluated with Abbott’s SARS-CoV-2 assays in more than 60 publication/evaluations, seeking to provide key insights. Here are a few examples.
Check back frequently for more resources.
Publication | Description |
Evaluation from University of Texas Southwestern Medical Center demonstrated a strong clinical performance of three distinct serological assays and their utility in evaluating and distinguishing serological responses to infection and vaccination. | |
Study highlighted the value of low-cost serosurveys targeting both symptomatic and asymptomatic populations to evaluate the natural immune response to SARS-CoV-2 in nonvaccinated susceptibles and design evidence-based policies for lifting lockdowns. | |
Team of researchers in Strasbourg, France, assessed the kinetics of SARS-CoV-2 antibodies and evaluated protection against reinfection and durability of vaccine protection. | |
The Abbott Global Viral Surveillance program, in collaboration with researchers from Guy’s and St Thomas’ NHS Foundation, evaluated SARS-CoV-2 variants and their impact on diagnostic assay performance. | |
Study from Tel Aviv University assessed humoral immune response and the factors associated with it in dialysis patient following vaccination. | |
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. | |
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. | |
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. |
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Infectious Disease Assays
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