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Test Code COVIDGAB SARS-CoV-2 Antibody, IgG

Performing Laboratory

Northwell Health Laboratories

Methodology and Reference Values

    Instrument       Methodology   Anti-SARS-CoV-2 Antibody Interpretation
     
Inova Quantilink/QL 3000        Euroimmun ELISA Negative </= 0.7 Ratio
    Equivocal 0.8 - 1.0 Ratio
    Positive >/= 1.1 Ratio
     
Dynex DSX        Ansh Labs ELISA  Negative </= 9.9 AU/mL
    Equivocal 10.0 - 12.0 AU/mL
    Positive >/= 12.1 AU/mL
     
Abbott Architect      Abbott CMIA Negative </= 1.3 Index
    Positive >/= 1.4 Index
     
Diasorin Liaison XL      Diasorin CMIA Negative    </= 14.9 AU/mL
    Positive       >/= 15.0 AU/mL
     
Ortho Vitros 3600      Ortho Immunometric IgG Negative </= 0.9 Index
    Positive >/= 1.0 Index
     
Roche 801 Roche ECLIA Total (GAM) Ab Negative </= 0.9 Index
    Positive >/= 1.0 Index

Test Classification and CPT Coding

86769

Specimen Requirements

Container/Tube: Gold top tube, Red top tube or MInt Green Lithium Heparin

Specimen: 1.0 mL serum or plasma (0.5 mL min)

Transport Temperature: Refrigerated

Stability:   24 Hrs Room Temperature

                 14 Days Refrigerated

                   6 Months Frozen

 

Day(s) and Time(s) Performed

Sunday - Saturday

TAT: 2 Days

Computer Interface Code

PDM # 2057204

Interpretive Data

This test has not been reviewed by the FDA. It has been validated to be accurate

by Northwell Health Laboratories.

 

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

 

Northwell Health Laboratories, through extensive validation testing, has confirmed that this risk is minimal with this test