Ordering Recommendation

Use for the qualitative detection of IgG antibodies against the nucleocapsid protein 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 by ELISA 3002723).

Mnemonic
COV19QUALG
Methodology

Qualitative Chemiluminescent Immunoassay

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) or EDTA plasma

Specimen Preparation

Separate serum or plasma from cells ASAP or within 2 hours of collection. Transfer 0.5mL serum or plasma to an ARUP Standard Transport Tube. (Min: 0.25 mL)

Storage/Transport Temperature

Refrigerated

Unacceptable Conditions

Grossly hemolyzed, grossly icteric, or severely lipemic specimens.

Remarks

Preferred: ARUP Standard Transport Tube for specimen submission (ARUP Item# 15824).

Stability

Refrigerated: 1 week; Frozen: 1 month

Reference Interval

Negative

Interpretive Data

The COVID-19 IgG, Qualitative by CIA test is for in vitro diagnostic use under an 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 information 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
3002777 COVID-19 IgG, Qualitative 94507-1
* 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, Qualitative by CIA