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.
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|
(Positive Percent Agreement)
|Measures test ability to correctly identify positive samples as positive.||100%*||100%*|
(Negative Percent Agreement)
|Measures test ability to correctly identify all negative results||100%||98.14%|
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.
(Due to previous infection or vaccination)
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.