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SARS-CoV-2 Antibody, IgG

CPT: 86769
Updated on 11/4/2020
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Synonyms

  • COVID-19
  • Severe Acute Respiratory Syndrome (SARS)

Expected Turnaround Time

1 - 3 days


Related Documents

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper


Specimen Requirements


Specimen

Serum


Volume

0.5 mL


Minimum Volume

0.4 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube or serum from red-top tube or serum transfer tube


Collection

Standard aseptic procedures


Storage Instructions

Room temperature


Stability Requirements

Temperature

Period

Room temperature

3 days

Refrigerated

7 days

Frozen

7 days

Freeze/thaw cycles

Stable x3


Patient Preparation

No special preparation required.


Causes for Rejection

Gross hemolysis; visible microbial contamination; specimen type other than serum


Test Details


Use

Qualitative detection of IgG antibodies to SARS-CoV-2, the virus that causes COVID-19, to help identify individuals who have been exposed to the virus. Serologic results should not be used as the sole basis to diagnose or exclude recent SARS-CoV-2 infection. This test is recommended in individuals at least 10 days post symptom onset or following exposure to individuals with confirmed COVID-19.


Limitations

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b) (1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens.

∗Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.

∗Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

∗Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.


Methodology

Immunoassay


Additional Information

The incubation period for COVID-19 ranges from 5 to 7 days. Current literature suggests that detectable IgG-class antibodies against SARS-CoV-2 develop approximately 8 to 11 days following onset of symptoms. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. A positive serological result is not diagnostic but indicates that an individual has likely been infected with SARS-CoV-2 and produced an immune response to the virus. It is not known at this time whether detectable antibody correlates with immunity. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing. While contingent on a variety of factors, this could be due to testing too early in the course of infection, the absence of exposure to the virus, or the lack of adequate immune response, which can be due to conditions or treatments that suppress immune function.

∗FDA-authorized Fact sheets for patients and providers can be accessed at the following link: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd


References

Coronavirus Disease 2019 (COVID-19). Centers for Disease Control and Prevention web site. https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html. Accessed March 2020.
Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff: March 2020. US Food & Drug Administration web site. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-diagnostic-tests-coronavirus-disease-2019-during-public-health-emergency. Accessed March 2020.
Woo PC, Lau SK, Wong BH, et al. Differential Sensitivities of Severe Acute Respiratory Syndrome (SARS) Coronavirus Spike Polypeptide Enzyme-Linked Immunosorbent Assay (ELISA) and SARS Coronavirus Nucleocapsid Protein ELISA for Serodiagnosis of SARS Coronavirus Pneumonia. J Clin Microbiol. 2005 Jul;43(7):3054-3058.16000415
Yu F, Le MQ, Inoue S, et al. Recombinant truncated nucleocapsid protein as antigen in a novel immunoglobulin M capture enzyme-linked immunosorbent assay for diagnosis of severe acute respiratory syndrome coronavirus infection. Clin Vaccine Immunol. 2007 Feb;14(2):146-149.17202310

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
164055 SARS-CoV-2 Antibody, IgG 94563-4 164057 SARS-CoV-2 Antibody, IgG 94563-4
Reflex Table for SARS-CoV-2 Antibody, IgG
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164056 Euroimmun SARS-CoV-2 Ab, IgG 164056 Euroimmun SARS-CoV-2 Ab, IgG 94563-4
Reflex Table for SARS-CoV-2 Antibody, IgG
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164059 IDK SARS-CoV-2 Antibody, IgG 164059 IDK SARS-CoV-2 Antibody, IgG 94563-4
Reflex Table for SARS-CoV-2 Antibody, IgG
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164060 DiaSorin SARS-CoV-2 Ab, IgG 164060 DiaSorin SARS-CoV-2 Ab, IgG 94563-4
Reflex Table for SARS-CoV-2 Antibody, IgG
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 164058 GSD SARS-CoV-2 Antibody, IgG 164058 GSD SARS-CoV-2 Antibody, IgG 94563-4

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