Professional Documents
Culture Documents
EUA Abbott Igg HCP
EUA Abbott Igg HCP
EUA Abbott Igg HCP
Disease 2019
SARS-CoV-2 IgG assay - Abbott Laboratories Inc. December 1, 2020
(COVID-19)
All individuals whose specimens are tested • SARS-CoV-2 IgG assay can be ordered by
with this assay will receive the Fact Sheet for healthcare providers to test human serum (including
Recipients: SARS-CoV-2 IgG assay. collected using a serum separator tube) and plasma
(ACD, CPD, CPDA-1, dipotassium EDTA,
tripotassium EDTA, lithium heparin, lithium heparin
What are the symptoms of COVID-19?
in a separator tube, sodium citrate, sodium heparin)
Many patients with confirmed COVID-19 have developed
specimens to detect if there has been an adaptive
fever and/or symptoms of acute respiratory illness (e.g.,
immune response to COVID-19, indicating recent or
cough, dyspnea), although some individuals experience
prior infection.
only mild symptoms or no symptoms at all. The current
information available to characterize the full spectrum of • SARS-CoV-2 IgG assay should not be used to
clinical illness associated with COVID-19 suggests that, diagnose or exclude acute infection and should not
when present, symptoms include cough, shortness of be used as the sole basis for treatment or patient
breath or dyspnea, fever, chills, myalgias, headache, management decisions. Direct testing for SARS-
sore throat, new loss of taste or smell, nausea or CoV-2 should be performed if acute infection is
vomiting or diarrhea. Signs and symptoms may appear suspected.
any time from 2 to 14 days after exposure to the virus, • SARS-CoV-2 IgG assay is only authorized for use in
and the median time to symptom onset is approximately laboratories certified under the Clinical Laboratory
5 days. For further information on the symptoms of Improvement Amendments of 1988 (CLIA), 42
COVID-19 please see the link provided in “Where can I U.S.C. §263a, to perform moderate or high
go for updates and more information?” section. complexity tests.
• Please refer to the SARS-CoV-2 IgG assay
Public health officials have identified cases of COVID-19 instructions for use for additional information.
infection throughout the world, including the United
States, which poses risks to public health. Please check
the CDC webpage (see link provided in “Where can I go Specimens should be collected with appropriate infection
for updates and more information?” section at the end of control precautions. Current guidance is available at the
this document) or your local jurisdiction’s website for the CDC’s website (see links provided in “Where can I go for
most up to date information. updates and more information” section).
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
1|Page
FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Disease 2019
SARS-CoV-2 IgG assay - Abbott Laboratories Inc. December 1, 2020
(COVID-19)
False positive results may occur due to cross-reactivity Risks to a patient of a false negative result include:
from pre-existing antibodies or other possible causes. restriction of activities deemed acceptable for individuals
The SARS-CoV-2 IgG assay has been designed to with evidence of an IgG response to SARS-CoV-2, lack
minimize the likelihood of false positive test results. of monitoring of infected individuals and their household
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
2|Page
FACT SHEET FOR HEALTHCARE PROVIDERS Coronavirus
Disease 2019
SARS-CoV-2 IgG assay - Abbott Laboratories Inc. December 1, 2020
(COVID-19)
Report Adverse events, including problems with test performance or results, to MedWatch by submitting the online FDA Form 3500
(https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) or by calling 1-800-FDA-1088
3|Page