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Test Code COV2AB SARS-CoV-2 Antibody, IgG

Important Note

For use under FDA Emergency Use Authorization (EUA) only.

  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Testing with a molecular diagnostic should be considered to evaluate for active 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.
  • Cross-reactivity with antibodies to non-SARS-CoV-2 coronavirus strains (HKU1, NL63, OC43 and 229E) have not been evaluated by this assay.
  • Not for the screening of donated blood.
  • It is uncertain at this time if positive serology implies long term immunity.

Additional Codes

ALAB: COV2AB

Powerchart: SARS CoV2 COVID Corona Antibody IgG

MA Cerner: SARS-CoV-2 IgG

Specimen Requirement

EDTA plasma or serum is acceptable

Collection Instructions:

  • Minimum volume: 0.5 mL
  • Hemolysis: Grossly hemolyzed specimens will be rejected.
  • Lipemia: No information
  • Icterus:  No information
  • Storage: Specimens are stable at room temperature for up to 2 days or may be stored refrigerated for up to 7 days.

Method

Chemiluminescent Microparticle Immunoassay (CMIA); Abbott Architect

Reference Value

Negative

The cutoff is 1.4 Index (S/C). Index < 1.4 is negative. Index ≥ 1.4 is positive. 

Useful For

The detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.

Performance

Testing is performed Monday through Friday. Batched run once per day during the PM shift.

CPT Code Information

86769

LOINC Code Information

94563-4