Use for the detection of IgG antibodies against the spike protein (S1) of SARS-CoV-2 (COVID-19) that develop in response to natural infection with SARS-CoV-2 or from a COVID-19 vaccination. There are no current recommendations for assessing COVID-19 vaccine response.
To reduce the likelihood of a false-positive result, the CDC Interim Guidelines for COVID-19 Antibody Testing suggest using an orthogonal testing algorithm so that individuals positive by one antibody test are retested with a second antibody test (refer to COVID-19 IgG, Qualitative by CIA 3002776).
Enzyme-Linked Immunosorbent Assay
New York DOH Approval Status
Serum separator tube (SST).
Separate serum from cells ASAP or within 2 hours of collection. Transfer 1 mL serum to an ARUP Standard Transport Tube. (Min: 0.1 mL)
Grossly hemolyzed, grossly icteric, or severely lipemic specimens.
Required: Submit specimen in ARUP Standard Transport Tube (ARUP Item # 15824) only.
Do not submit sample in original SST collection tube.
Ambient: 24 hours; Refrigerated: 2 weeks; Frozen: 1 month
|0.7 Index or less||Negative|
|1.1 Index or greater||Positive|
This test is for in vitro diagnostic use under the FDA Emergency Use Authorization (EUA). In compliance with this authorization, please visit https://www.aruplab.com/infectious-disease/coronavirus/testing for more information and to access the applicable fact sheets. This test should not be used for screening of donated blood.
Emergency Use Authorization (EUA)
|Component Test Code*||Component Chart Name||LOINC|
|3002726||COVID-19 IgG IV||94505-5|
- Coronavirus Disease - 2019
- COVID-19 Illness
- COVID19 IgG Ab