Ordering Recommendation

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.

New York DOH Approval Status

This test is New York state approved.

Specimen Required

Patient Preparation
Collect

Serum separator tube (SST). Also acceptable: lithium heparin.

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 1 mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.5 mL)

Storage/Transport Temperature

Refrigerated.

Unacceptable Conditions

Specimens containing particulate material or otherwise obviously contaminated. Severely hemolyzed, heat-inactivated, severely icteric, or lipemic specimens. Postmortem specimens.

Remarks
Stability

After separation from cells: Ambient: 72 hours; Refrigerated: 1 week; Frozen: 1 month (avoid repeated freeze/thaw cycles)

Methodology

Semi-Quantitative Chemiluminescent Immunoassay (CLIA)

Performed

Sun-Sat

Reported

Within 24 hours

Reference Interval

Less than 1.00 Index Value Negative
Greater than or equal to 1.00 Index Value 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.

Compliance Category

Emergency Use Authorization (EUA)

Note

Hotline History

N/A

CPT Codes

86769

Components

Component Test Code* Component Chart Name LOINC
3003649 COVID-19 IgG Index by CIA 94505-5
3003650 COVID-19 IgG by CIA Interpretation 94563-4
* 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 Ab
  • COVID Antibody
  • COVID Antibody Test
  • COVID-19 Illness
  • COVID-2019
  • COVID19 IgG Ab
  • SARS-CoV-2
COVID-19 IgG (Spike), Semi-Quantitative by CIA