Ordering Recommendation

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).

Mnemonic
COVID19IGG
Methodology

Enzyme-Linked Immunosorbent Assay

Performed

Sun-Sat

Reported

1-5 days

New York DOH Approval Status
This test is New York DOH approved.
Specimen Required
Patient Preparation
Collect

Serum separator tube (SST).

Specimen Preparation

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)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Grossly hemolyzed, grossly icteric, or severely lipemic specimens.

Remarks

Required: Submit specimen in ARUP Standard Transport Tube (ARUP Item # 15824) only.
Do not submit sample in original SST collection tube.

Stability

Ambient: 24 hours; Refrigerated: 2 weeks; Frozen: 1 month

Reference Interval

Negative

0.7 Index or less Negative
0.8-1.0 Index Indeterminate
1.1 Index or greater Positive

Interpretive Data

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.

Compliance Category

Emergency Use Authorization (EUA)

Note
Hotline History
N/A
CPT Codes

86769

Components
Component Test Code* Component Chart Name LOINC
3002725 COVID-19 IgG 94563-4
3002726 COVID-19 IgG IV 94505-5
* Component test codes cannot be used to order tests. The information provided here is not sufficient for interface builds; for a complete test mix, please click the sidebar link to access the Interface Map.
Aliases
  • 2019-nCoV
  • Coronavirus Disease - 2019
  • COVID-19 Illness
  • COVID-2019
  • COVID19 IgG Ab
  • SARS-CoV-2
  • Wuhan
COVID-19 IgG by ELISA