Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  

SARS-COV-2 ANTIBODY

ORDERING INFORMATION:
Geisinger Epic Procedure Code: LAB3785         Geisinger Epic ID: 140789

SPECIMEN COLLECTION
Specimen type:
Serum or plasma
Preferred collection container:
Specimen required:
Minimum 0.2 mL
Special notes:
This assay is not appropriate to evaluate antibody levels post vaccination.

SPECIMEN PROCESSING
Specimen processing instructions:
Allow serum to clot. Centrifuge to separate serum or plasma. 
Transport temperature:
Refrigerated.
Specimen stability:
After separation: Room temperature: 7 days. Refrigerated (2-8°C): 7 days. Frozen: 28 days.
Rejection criteria:
Specimen will be rejected if the stability limit is exceeded or if specimen is hemolyzed, lipemic, or icteric

TEST DETAILS
Reference interval:
Negative.
Interpretation guide:

Positive

The presence of antibodies to SARS-CoV-2 is consistent with recent or past COVID-19 infection.  Correlation with clinical findings is recommended.  The presence of antibodies is not an indication of immunity to SARS-CoV-2.  

Negative

No antibodies to SARS-CoV-2 detected. Negative results may occur in patients that are immunosuppressed or in specimens collected <=14 days after symptom onset. Additionally, antibodies may decline overtime and become negative. If acute or early COVID-19 infection is highly suspected, molecular testing for acute infection is recommended.

CPT code(s):
86769
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.  The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.
Test includes:
Qualitative detection of (primarily) IgG antibodies against the nucleocapsid protein of SARS-CoV-2.
Methodology:
Chemiluminescence Immunoassay
Synonyms:
SARS-CoV-2 Serology, Covid-19 antibody, Covid-19 serology
Covid Antibody, ACOV19
Clinical significance:
Clinically, SARS-CoV-2 antibody tests are potentially useful for identifying convalescent plasma donors and for identifying potential past exposure to SARS-CoV-2 when patients present late (>/= 14 days) after symptom onset and have a negative molecular test. Antibody testing will also play a key role in epidemiology studies.

SARS-CoV-2 antibody tests are not appropriate to determine “return to work” status. Presence of antibody is only indicative of previous infection, not immunity. Currently, there is NO evidence that development of antibodies create immunity. In our internal validation, antibody test results approach 100% sensitivity 14-days post diagnosis of infection. However, it is unknown how long antibodies persist after infection. Antibody tests are not appropriate for diagnosing or ruling out acute infection. Molecular tests remain the appropriate test for diagnosing acute infection.
Doctoral Director(s:)
Hoi-Ying Elsie Yu, PhD, DABCC
Stacy Kenyon, PhD, DABCC
   
Review Date: 03/01/2021

Performing Locations

Geisinger Medical Center

Performing laboratory: Automated Chemistry
Technical Lead: Mariana Moyer, Jared Shepherd
Frequency: Daily
Performed stat? No
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