Ordering Recommendation

Use for the qualitative detection of IgG antibodies against the nucleocapsid protein of SARS-CoV-2 (COVID-19) that develop in response to natural infection with SARS-CoV-2. These antibodies do not develop as a result of 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) 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. Postmortem specimens.

Remarks

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

Stability

Refrigerated: 1 week; Frozen: 1 month

Methodology

Qualitative Chemiluminescent Immunoassay (CLIA)

Performed

Mon, Wed, Fri

Reported

1-5 days

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.
Use for the qualitative detection of IgG antibodies against the nucleocapsid protein of SARS-CoV-2 (COVID-19) that develop in response to natural infection with SARS-CoV-2. These antibodies do not develop as a result of a COVID-19 vaccination. There are no current recommendations for assessing COVID-19 vaccine response.

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 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-19 Illness
  • COVID-2019
  • COVID19 IgG Ab
  • SARS-CoV-2
COVID-19 IgG, Qualitative by CIA