Use for the detection of IgG antibodies against the spike protein (S1) of SARS-CoV-2 (COVID-19) to evaluate exposure. 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
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.
No compliance statements are in use for this test.
|Component Test Code*||Component Chart Name||LOINC|
|3002726||COVID-19 IgG IV||94505-5|
- Coronavirus Disease - 2019
- COVID-19 Illness
- COVID19 IgG Ab