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Epic Code LAB1230623 Discontinued: COVID-19 IgG Antibody

Important Note

This test was discontinued on 3/17/21. Replacement test: LAB1230810

COVID-19 IgG Antibody test (LAB1230623) does not assess for immune response to mRNA vaccines encoding the spike protein of SARS-CoV-2.  Current testing consists of a two-test algorithm consisting of a first-tier total antibody assay that targets the viral nucleocapsid component and if positive, the specimen will reflex to an IgG-specific antibody assay that targets the viral spike component.  Therefore, persons receiving spike mRNA vaccines will have undetectable antibodies in the first-tier total anti-nucleocapsid assay and will not reflex to the IgG anti-spike assay. 

Clinical Information

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a positive-sense, single-stranded RNA virus that causes coronavirus disease 2019 (COVID-19). The COVID-19 IgG Antibody test is intended for the qualitative detection of IgG-class antibodies against COVID-19.  A positive IgG result indicates previous infection with COVID-19 but does not indicate immunity or protection against future infection.  Serology testing is recommended only for individuals at least 10-14 days either post-symptom onset or following an exposure to individuals with confirmed COVID-19 infection.  Patients tested prior to this time may be falsely negative for IgG antibodies.  Serology testing may be used to screen patients as donors of convalescent plasma for use as a therapeutic.  This test should not be used to detect acute COVID-19 disease.  Symptomatic patients suspected to have acute COVID-19 infection should be tested using a molecular assay.

Reference Range

Negative

No IgG antibodies to SARS-CoV-2 detected. 

Negative results do not preclude SARS-CoV-2 infection.  Negative results may occur in serum collected too soon following infection, in immunosuppressed patients, or in some individuals with prior mild illness.  Most immunocompetent individuals with SARS-CoV-2 infection will develop detectable IgG-class antibodies approximately 10 days following onset of symptoms.  Patients tested prior to this time may be negative for IgG antibodies.  Follow-up testing with a molecular test is recommended in symptomatic patients.  Results from serologic testing should not be used as the sole basis to diagnose or exclude active and/or recent SARS-CoV-2 infection.  Results should be assessed in conjunction with the patient’s medical history, epidemiologic risk factors, clinical examination, and other laboratory findings.

 

Indeterminant

Repeat testing in 7 to 10 days may be considered to determine definitive serologic status.

 

Positive

SARS-CoV-2 IgG antibodies detected. 

Results suggest recent or prior infection with SARS-CoV-2.  Serologic tests should not be used to diagnose acute SARS-CoV-2 infection.  If acute infection is suspected, molecular testing for SARS-CoV-2 is suggested.  It is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity.  False positive results may occur, but are not expected, due to prior infection with other human coronaviruses (e.g. SARS-CoV-1, HKU1, NL63, OC43, 229E), from pre-existing antibodies, or other possible causes.  Results from serologic testing should not be used as the sole basis to diagnose or exclude active and/or recent SARS-CoV-2 infection.  Results should be assessed in conjunction with the patient’s medical history, epidemiologic risk factors, clinical examination, and other laboratory findings.

Performing Department

Chemistry and Immunochemistry

Performing Department Laboratory Location

Spectrum Health Regional Laboratory (SHRL BW), Grand Rapids, MI

Methodology

ELISA and ECLIA

CPT

86769

Epic Test ID

1230102243

LOINC

94762-2

Beaker LOINC

COVID MDI: N/A
COVID METHOD (KIT): N/A
COVID-19 ANTIBODY: 94762-2

Reviewed Date

3/17/2021

Beaker Names

Beaker Procedure Name: COVID-19 IGG ANTIBODY
Beaker Display Name: COVID-19 IgG Antibody
BEAKER TEST NAME: COVID-19 IGG ANTIBODY
BEAKER TEST REPORT NAME: COVID-19 IgG Antibody

Beaker Synonyms

COVID-19|COVID|CORONAVIRUS

Beaker Location, Container and Temperature

BW CHEMISTRY: GOLD TOP SST TUBE R (Preferred)-Refrigerated
BW IMMUNOCHEM: GOLD TOP SST TUBE R (Preferred)-Refrigerated