Severe Acute Respiratory Syndrome

Coronavirus 2 (SARS-CoV-2) IgG Antibody, Serum

COR2G – Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) IgG Antibody, Serum

COR2G : Detection of IgG-class antibodies against severe acute respiratory syndrome coronavirus 2, agent of coronavirus disease 2019 (COVID-19). Detection of IgG-class antibodies against severe acute respiratory syndrome coronavirus 2, agent of coronavirus disease 2019 (COVID-19)

This test provides qualitative detection of serum IgG-class antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of coronavirus disease 2019 (COVID-19)

Test should not be used to detect recent or acute COVID-19.

Testing is only recommended in individuals at least 10 days post-symptom onset or following exposure to individuals with confirmed COVID-19.


Advisory Information

Molecular testing is the recommended diagnosis of coronavirus disease 2019 (COVID-19) in symptomatic patients. For more information see:
COVID / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection


Reject Due To:

Gross hemolysisReject
Gross lipemiaReject
Gross icterusReject
Heat inactivated serumReject

Useful For

Detection of IgG-class antibodies against severe acute respiratory syndrome coronavirus 2, agent of coronavirus disease 2019 (COVID-19)


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). Like other coronaviruses that infect humans, SARS-CoV-2 can cause both upper and lower respiratory tract infections. Symptoms can range from mild (ie, the common cold) to severe (ie, pneumonia) in both healthy and immunocompromised patients. SARS-CoV-2 transmission occurs primarily via respiratory droplets. During the early stages of COVID-19, symptoms may be nonspecific and resemble other common respiratory tract infections, such as influenza.

The incubation period for COVID-19 ranges from 5 to 7 days. Typically, immunocompetent individuals with COVID-19 develop detectable IgG-class antibodies against SARS-CoV-2 approximately 8 to 11 days following the onset of symptoms. Patients tested prior to this time may be negative for SARS-CoV-2 IgG antibodies.


Interpretation

Negative:

No IgG antibodies to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) detected. Negative results may occur in serum collected too soon following infection, or in immunosuppressed patients.
Indeterminate (Index of > or =1.01 to <1.21):

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. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. Serologic results should not be used as the sole basis to diagnose recent SARS-CoV-2 infection. Infrequently, false-positive results may be due to prior infection with other human coronaviruses.


Cautions

Symptomatic patients suspected to have acute coronavirus disease 2019 (COVID-19) should be tested using a molecular assay to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA. For more information see:
COVID / Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection,

Serologic testing should not be used to diagnose SARS-CoV-2 infection in symptomatic patients presenting soon after symptom onset due to the risk of false-negative serologic results.

False-negative serologic results may occur in serum collected too soon after symptom onset. Typically, the majority of patients seroconvert between 8 to 11 days post-symptom onset; specimens collected and tested prior to this time point may be negative.

False-positive results may occur in a small percentage of individuals. Preliminary data indicate minimal cross-reactivity between antibodies to SARS-CoV-2 and the commonly circulating coronavirus strains, OC43, 229E, NL63, and HKU1.

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