LABCORP
Turnaround time
3 – 5 days
Specimen
Serum
Volume
0.5 mL
Minimum volume
0.4 mL (Note: This volume does not allow for repeat testing.)
Container
Gel-barrier tube or serum from red-top tube or serum transfer tube
Stability requirements
ROOM TEMP: 3 days
REFRIGERATED: 7 days
FROZEN: 7 days
FREEZE / THAW CYCLES: stable x3
Patient preparation
No special preparation required
Causes for rejection
Gross hemolysis; visible microbial contamination; specimen type other than serum
Use
Qualitative detection of IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, to help identify individuals who have been exposed to the virus. Serologic results should not be used as the sole basis to diagnose or exclude recent SARS-CoV-2 infection. This test is recommended in individuals at least 10 days post symptom onset or following exposure to individuals with confirmed COVID-19.
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 may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This test was developed and its performance characteristics determined by LabCorp. It has not been cleared or approved by the Food and Drug Administration.
CPT code
86769
SOURCE: LabCorp