SARS-CoV-2 Serology (COVID-19) Antibody (IgG), Immunoassay : 39504

Test Code
CVIGGP

Alias/See Also
SARS, Novel Coronavirus, nCOV, COVID-19, COVID, Wuhan, Coronavirus

CPT Codes
86769

Instructions
Serum separator tube (gold top preferred) or plain red top tube.

Transport Container
Centrifuge the serum separator tube and transport; if a plain red top tube, centrifuge and aliquot 1 mL serum  (Min. 0.5 mL ) into a standard transport tube.

Transport Temperature
Refrigerated.

Specimen Stability
Room temperature: 4 days; Refrigerated: 7 days; Frozen: 30 days

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Gross hemolysis, Gross lipemia, Grossly icteric

Methodology
Immunoassay

Setup Schedule
Sunday - Saturday

Report Available
1-2 days

Limitations
This test has not been reviewed by the FDA. Negative results do not rule out SARS-CoV-2 infection particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. Positive results could also be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.  This test is not to be used for the screening of donated blood.

Reference Range
Reference Range: Negative
   
Detection of IgG antibodies may indicate exposure to SARS-CoV-2 (COVID-19). It usually takes at least 10 days after symptom onset for IgG to reach detectable levels. An IgG positive result may suggest an immune response to a primary infection with SARS-CoV-2, but the relationship between IgG positivity and immunity to SARS-CoV-2 has not yet been firmly established. Antibody tests have not been shown to definitively diagnose or exclude SARS-CoV-2 infection. Diagnosis of COVID-19 is made by detection of SARS-CoV-2 RNA by molecular testing methods, consistent with a patient's clinical findings.
 

Clinical Significance
Detection of IgG antibodies may indicate exposure to SARS-CoV-2 (COVID-19). It usually takes at least 10 days after symptom onset for IgG to reach detectable levels. An IgG positive result may suggest an immune response to a primary infection with SARS-CoV-2, but the relationship between IgG positivity and immunity to SARS-CoV-2 has not yet been firmly established. Antibody tests have not been shown to definitively diagnose or exclude SARS-CoV-2 infection. Positive results could also be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.  Diagnosis of COVID-19 is made by detection of SARS-CoV-2 RNA by molecular testing methods, consistent with a patient’s clinical findings.

Performing Laboratory
med fusion



The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.