COVID-19 IgM & IgG Serology Antibody Test Conducted at the Point of Care

This test should only be used by medical offices or other facilities with an NPI number.

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Overview

  • Turnaround time: 20 min.
  • Authorized (EUA)

The purpose of COVID-19 IgM & IgG serology antibody testing is to determine whether a patient has been exposed to COVID-19 and has potentially developed immunity. Patients with COVID-19 specific antibodies developed through previous infection or vaccination can test positive for IgM, IgG or both.

Test Performance

There are two key metrics that are often used to assess the quality and accuracy of an assay, sensitivity and specificity.

Metric Definition IgG Results IgM Results
Sensitivity
(Positive Percent Agreement)
Measures test ability to correctly identify positive samples as positive. 100%* 100%*
Specificity
(Negative Percent Agreement)
Measures test ability to correctly identify all negative results 100% 98.14%
*≥ 15 days following disease onset

Key Benefits

First U.S. company granted FDA EUA for point-of-care antibody test.

Uses RBD as antigen (same target as vaccination).

Easy to use,
with no additional equipment required.

Reimbursement at $45/test.

IgM & IgG Antibody Development

(Due to previous infection or vaccination)

  • IgM antibodies are the first to develop and may indicate an early immune response and that the patient was recently infected.
  • IgG follows and can be detected as early as 6 days following disease onset. The presence of IgG may point to a potentially longer term immune response.
  • The purpose of vaccination is for your body to develop an immune response. After being vaccinated, you may test positive for COVID-19 antibodies.
  • Experts are currently evaluating the potential effect of COVID-19 vaccination on antibody testing results.

Each test kit includes

25 test cassettes

25 lancets

25 pipettes

1 bottle of sample buffer

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Key Documents

Disclaimer:

This test has not been FDA cleared or approved but has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for detecting the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens; and the emergency use of this test is 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.