Understanding if a patient has been recently or previously infected with SARS-CoV-2 and how long antibodies stay in the body is important for the continued management of COVID-19. Serology tests can provide this broader picture. Abbott has partnered with laboratories around the world in the COVID-19 crisis by providing 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.
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.
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.
Download SARS-CoV-2 IgG II Semi-Quant EUA Resources
Analytical specificity: No cross-reactivity observed from individuals with other medical conditions, including Human Coronavirus 229E, HKU1, NL63, or OC43.1,2
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
Download the AdviseDx SARS-CoV-2 IgM EUA Resources
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
Download SARS-CoV-2 IgG EUA Resources
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).
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.
|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 is your total laboratory solution, a unified, holistic family of systems designed to deliver unprecedented integration across your laboratory. 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.
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.
Visit our e-commerce website to quickly and efficiently order
SARS-CoV-2 assays online.
For more information contact your Abbott Representative.
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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